Leaflet: information for the user

Osmohale powder for inhalation (hard capsules)

mannitol

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Osmohale is and for what it is used

2. What you need to know before starting to take Osmohale

3. How to take Osmohale

4. Possible side effects

5. Storage of Osmohale

6. Contents of the pack and additional information

Osmohale is atestto check if you have sensitivity in the respiratory tracts or not.

Osmohale contains the active ingredient manitol.

Sensitivity in the respiratory tracts can be caused by inflammation of these, which sometimes makes breathing difficult. People with sensitivity in the respiratory tracts are often very susceptible to environmental factors such as exercise, dust, smoke, and other irritating factors.

Your doctor or another specifically trained healthcare professional will ask you to breathe in Osmohale using a small inhaler.

• In people whoactuallyhaverespiratory tract sensitivity, these will constrict, and it may be more difficult to breathe.
• People whodo nothaverespiratory tract sensitivitywill not experience such constriction of these when breathing in Osmohale, and will be able to continue breathing normally.

As part of the test, you will be asked to blow into a tube that will measure the effect of Osmohale on your lungs.

This medication is used exclusively to check if you have sensitivity in the respiratory tracts.

Do not take Osmohale

• if you areallergic(hypersensitive) to mannitol or any of the other components;
• if yourlung capacityisseverely reduced(this will be measured before the test);
• if you currently have or have had a blood vessel that is distended or weakened around the heart or brain (aneurysm);
• if you haveuncontrolled hypertension;
• if you have had amyocardial infarctionin the last 6 months;
• if you have had astrokein the last 6 months.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Osmohale.

• if yourlung capacityisreduced(this will be measured before the test);
• if you have previously experienceddifficulty breathing,or have hadwheezingorcoughingduring a spirometry (study where you blow into a measuring instrument);
• if youexpectorate blood;
• if you have air in the pleural space between the chest wall and the lungs, causing chest pain and shortness of breath (pneumothorax);
• if you have recently undergoneeye surgery, stomach surgery or chest surgery;
• if you experience chest pain (angina pectoris);
• if you havedifficulty performing the spirometry(the person performing it will inform you);
• if you have had arespiratory tract infectionin the last 2 weeks.

If you experience shortness of breath, wheezing and/or coughing during the spirometry, it is possible that a medication will be administered to keep your airways open, and the test will be stopped.

Do not perform strenuous exerciseson the day of the test, especially before performing it, as it may affect the results.

Do not smokefor at least 6 hours before the test, as it may affect the results.

Do not take Osmohale on your own. Osmohale should only be administered in a clinic or laboratory, by trained professionals familiar with the use of similar tests and their possible effects, under the supervision of an experienced doctor.

Children and adolescents

Osmohale should not be administered to children under 6 years old.

Osmohale is not recommended for patients between 6 and 18 years old, due to the limited information available on the use of the medication in this population.

Other medications and Osmohale

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

If you are using other medications for the treatment of asthma or allergies, you may need to stop taking them before the test. These medications may affect your body's reaction to Osmohale. Your doctor will tell you which medication(s) to stop, and for how long (usually between 6 hours and 4 days before the test).

Use of Osmohale with food and drinks

On the day of the test, do not drink coffee, tea or cola, or eat chocolate or other foods that contain caffeine.

Pregnancy, breastfeeding and fertility

Do not undergo the test with Osmohale if you are pregnant.

You can use Osmohale during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No effects have been observed.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

A doctor or other specially trained healthcare professional will administer Osmohale through an inhaler and accompany you during the test development. You will not be left alone.

Do not insert the Osmohale capsules into your mouth or swallow them.

Conducting the test

1. You will be asked to sit comfortably in a chair.
2. You will initially be asked to blow forcefully into a tube (spirometry).
3. Next, a nasal clip will be placed, so that you can only inhale and exhale through your mouth.
4. After exhaling all the air, you will be asked to inhale deeply the Osmohale medication, using a special inhaler.
5. You will then be instructed to hold your breath for five seconds before exhaling.
6. The nasal clip will be removed, and you will be asked to breathe normally.
7. You will then be asked to blow forcefully into the tube again. This test measures the effect of Osmohale on your lungs.
8. Steps 3 to 7 may be repeated a maximum of 9 times, with more Osmohale depending on the effect on your lungs (as measured in step 7), until the test is completed.
9. Once the study is completed, you may be administered some medication to help you breathe.

If you are unsure about any part of the test, or have any questions about the medication, speak with the doctor or specially trained healthcare professional conducting the test.

If you take more Osmohale than you should

If you think you may have been administered an excessive amount of the medication, inform the doctor or healthcare professional conducting the test immediately. If you have taken too much Osmohale, you may feel like you cannot breathe, experience wheezing or coughing. The doctor may administer oxygen or medication to help you breathe.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Adverse Effects List

Common(may affect 1 in 10 people):

• Asthma
• Shortness of breath
• Chest tightness
• Coughing
• Nausea
• Headache
• Nasal congestion and throat discomfort
• Runny nose
• Vomiting

Rare(may affect 1 in 100 people):

• Cold extremities
• Diarrhea
• Dizziness
• Anxiety
• Thirst
• Fatigue
• Erythema and sweating
• Snoring
• Itching and skin rash
• Eye itching
• Reduced oxygen in the blood
• Mouth ulcers
• Nosebleeds
• Abdominal pain
• Muscle and joint pain

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even

if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in the

Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Osmohale

The active ingredient is mannitol.

The capsules used for inhalation contain mannitol powder. A capsule contains 0 mg, 5 mg, 10 mg, 20 mg or 40 mg of mannitol.

Appearance of the product and contents of the pack

The powder is white or almost white.

The empty capsule is transparent with two white bands printed on it.

The 5 mg capsule is half white and half transparent, with the inscription 5 mg.

The 10 mg capsule is half yellow and half transparent, with the inscription 10 mg.

The 20 mg capsule is half pink and half transparent, with the inscription 20 mg.

The 40 mg capsules are half red and half transparent, with the inscription 40 mg.

The capsules are presented in blisters. A diagnostic kit, packaged in a box, consists of:

• 1 empty capsule
• 1 capsule of 5 mg
• 1 capsule of 10 mg
• 1 capsule of 20 mg
• 15 capsules of 40 mg
• 1 inhaler

Marketing Authorization Holder

Pharmaxis Europe Limited

108 Q House Furze Road,

Sandyford, Dublin 18,

D18AY29, Ireland

Manufacturer

MIAS Pharma Limited

Suite 1 Stafford House

Strand Road, Portmarnock

Co. Dublin, D13 WC83

Ireland

Arvato Supply Chain Solutions SE

Gottlieb-DaimlerStrasse 1

33428 Harsewinkel

North Rhine-Westphalia

Germany

If you have any questions about this medicine, please contact the local representative of the marketing authorization holder:

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Ll.

Barcelona

Spain

Phone: +34 93 372 71 11

Fax: +34 93 371 61 98

This medicine is authorized in the member states of the European Economic Area with the following names:

Aridol: Finland, Germany, Norway, Sweden

Osmohale: Denmark, Ireland, Netherlands, Spain, United Kingdom (Northern Ireland)

Last review date of this leaflet:06/2022

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

INFORMATION FOR MEDICAL PROFESSIONALS

This information is intended only for medical doctors or healthcare professionals:

Contraindications

Known hypersensitivity to mannitol or any of the components of the capsule.

Osmohale should not be administered to patients with severe respiratory limitation (FEV1 expected <50% or <1.0 l), or conditions that may be compromised by bronchoconstriction induction or repeated sputum induction. These include: cerebral or aortic aneurysm, uncontrolled hypertension, myocardial infarction or stroke in the six months prior.

Warnings and precautions for use

Osmohale should be administered exclusively by inhalation. Mannitol inhalation causes bronchoconstriction. The Osmohale challenge test should only be performed in suitable clinics or laboratories by a doctor or other healthcare professional properly trained to perform bronchial provocation tests and manage acute bronchoconstriction, and under the supervision of an experienced doctor. The responsible doctor, with proper training to treat acute bronchoconstriction, including the appropriate use of resuscitation equipment, should be close enough to respond quickly in case of an emergency. A stethoscope, sphygmomanometer, and pulse oximeter should be available. Once Osmohale administration has begun, the patient should not be left unattended during the procedure.

In the area where the test is performed, there should be available medications for the treatment of severe bronchoconstriction. These include adrenaline for subcutaneous injection, and salbutamol or other beta-2 agonists in dose-adjustable inhalers. There should be available oxygen. A small-volume nebulizer should be available for the administration of bronchodilators.

General precautions for spirometry and bronchial provocation tests, including additional precautions for patients with the following conditions, should be observed: respiratory insufficiency (FEV1 basal <70% of expected normal values or an absolute value of 1.5 l or less in adults), bronchoconstriction induced by spirometry, hemoptysis of unknown origin, pneumothorax, recent abdominal or thoracic surgery, recent intraocular surgery, unstable angina, inability to perform a satisfactory quality spirometry, or lower or upper respiratory tract infection in the two weeks prior.

If the patient presents with asthma induced by spirometry, or the FEV1 drop is greater than 10% after administration of the 0 mg capsule, a standard dose of bronchodilator should be applied and the Osmohale challenge test should be discontinued.

Exercises: Vigorous physical exercise should be completely avoided on the day of the test, as it may affect the results.

Smoking: As smoking may affect the test results, patients are recommended to abstain from it for at least 6 hours prior to the study.

The Osmohale challenge test should not be used in patients under 6 years of age, due to their inability to provide reproducible spirometric measurements.

The information on the use of Osmohale in patients aged 6 to 18 years is limited; therefore, the use of Osmohale in this population is not recommended.

The effects of repeated Osmohale tests in a short period have not been investigated; therefore, special consideration should be given to repeated use of Osmohale.

Instructions for the inhaler device

These instructions show how to use the inhaler

1.Removing the cap:Hold the inhaler vertically with both hands and remove the cap.

2.Opening:Hold the inhaler firmly with one hand, and open the device by turning the mouthpiece in the direction of the arrow, as shown in the image.

3.Loading:Make sure your hands are dry; remove a capsule from the inhaler container and place it in the inhaler as shown in the illustration.

It does not matter which side of the capsule is inserted into the chamber.

4.Closing:Hold the device vertically and turn the mouthpiece to the closed position until you hear a "click".

5.Perforating the capsule:Hold the inhaler vertically and press both perforation buttons on the sides of the device simultaneously and firmly.

Do this only once, as perforating the capsule more than once may cause it to break or fragment. The perforation opens holes in the capsule, allowing the powder to be released during inhalation.

6.Preparing for inhalation:Incline the inhaler so that the mouthpiece is at a 45-degree angle, as shown in the figure below, until the capsule falls into the rotating chamber. Hold the device at this angle and instruct the patient to exhale completely (outside the inhaler).

7.Inhalation:The patient should tilt their head slightly back, and holding the inhaler at a 45-degree angle, bring it to their mouth and adjust their lips to the mouthpiece. Instruct the patient to take a rapid and deep breath to fill their lungs. Then, the patient should hold their breath for 5 seconds.

Note: During a correct inhalation, you should hear a "cascabel" sound as the capsule rotates inside the device..

8.Exhalation:Remove the inhaler from the patient's mouth, and let them exhale and resume normal breathing.

9.Verification:To empty, the Osmohale capsule must rotate inside the inhaler. If, after inhalation, the capsule has not been emptied, a second inhalation (with the same capsule) may be required. Check the capsule after each inhalation.

Important note:

The inhaler is designed for SINGLE USE (one device per challenge test), and should not be cleaned during the test. Dispose of the inhaler after each challenge test with Osmohale. The inhaler should not be sterilized or reused, as this may compromise the integrity of the subsequent test results.

……………………………………………………………………………………………………..

READ THE FULL PRODUCT CHARACTERISTICS LEAFLET BEFORE PERFORMING THIS CHALLENGE TEST.

For more information, please contact:

Marketing Authorization Holder:

Pharmaxis Europe Limited

108 Q House Furze Road,

Sandyford, Dublin 18,

D18AY29, Ireland

Local Representative:

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Ll.

Barcelona

Spain

Phone: +34 93 372 71 11

Fax: +34 93 371 61 98

……………………………………………………………………………………………………..

Challenge test instructions for Osmohale

These instructions show how to use the inhaler

1.Removing the cap:Hold the inhaler vertically with both hands and remove the cap.

2.Opening:Hold the inhaler firmly with one hand, and open the device by turning the mouthpiece in the direction of the arrow, as shown in the image.

3.Loading:Make sure your hands are dry; remove a capsule from the inhaler container and place it in the inhaler as shown in the illustration.

It does not matter which side of the capsule is inserted into the chamber.

4.Closing:Hold the device vertically and turn the mouthpiece to the closed position until you hear a "click".

5.Perforating the capsule:Hold the inhaler vertically and press both perforation buttons on the sides of the device simultaneously and firmly.

Do this only once, as perforating the capsule more than once may cause it to break or fragment. The perforation opens holes in the capsule, allowing the powder to be released during inhalation.

6.Preparing for inhalation:Incline the inhaler so that the mouthpiece is at a 45-degree angle, as shown in the figure below, until the capsule falls into the rotating chamber. Hold the device at this angle and instruct the patient to exhale completely (outside the inhaler).

7.Inhalation:The patient should tilt their head slightly back, and holding the inhaler at a 45-degree angle, bring it to their mouth and adjust their lips to the mouthpiece. Instruct the patient to take a rapid and deep breath to fill their lungs. Then, the patient should hold their breath for 5 seconds.

Note: During a correct inhalation, you should hear a "cascabel" sound as the capsule rotates inside the device..

8.Exhalation:Remove the inhaler from the patient's mouth, and let them exhale and resume normal breathing.

9.Verification:To empty, the Osmohale capsule must rotate inside the inhaler. If, after inhalation, the capsule has not been emptied, a second inhalation (with the same capsule) may be required. Check the capsule after each inhalation.

Important note:

The inhaler is designed for SINGLE USE (one device per challenge test), and should not be cleaned during the test. Dispose of the inhaler after each challenge test with Osmohale. The inhaler should not be sterilized or reused, as this may compromise the integrity of the subsequent test results.

……………………………………………………………………………………………………..

Challenge test instructions for Osmohale

These instructions show how to use the inhaler

1.Removing the cap:Hold the inhaler vertically with both hands and remove the cap.

2.Opening:Hold the inhaler firmly with one hand, and open the device by turning the mouthpiece in the direction of the arrow, as shown in the image.

3.Loading:Make sure your hands are dry; remove a capsule from the inhaler container and place it in the inhaler as shown in the illustration.

It does not matter which side of the capsule is inserted into the chamber.

4.Closing:Hold the device vertically and turn the mouthpiece to the closed position until you hear a "click".

5.Perforating the capsule:Hold the inhaler vertically and press both perforation buttons on the sides of the device simultaneously and firmly.

Do this only once, as perforating the capsule more than once may cause it to break or fragment. The perforation opens holes in the capsule, allowing the powder to be released during inhalation.

6.Preparing for inhalation:Incline the inhaler so that the mouthpiece is at a 45-degree angle, as shown in the figure below, until the capsule falls into the rotating chamber. Hold the device at this angle and instruct the patient to exhale completely (outside the inhaler).

7.Inhalation:The patient should tilt their head slightly back, and holding the inhaler at a 45-degree angle, bring it to their mouth and adjust their lips to the mouthpiece. Instruct the patient to take a rapid and deep breath to fill their lungs. Then, the patient should hold their breath for 5 seconds.

Note: During a correct inhalation, you should hear a "cascabel" sound as the capsule rotates inside the device..

8.Exhalation:Remove the inhaler from the patient's mouth, and let them exhale and resume normal breathing.

9.Verification:To empty, the Osmohale capsule must rotate inside the inhaler. If, after inhalation, the capsule has not been emptied, a second inhalation (with the same capsule) may be required. Check the capsule after each inhalation.

Important note:

The inhaler is designed for SINGLE USE (one device per challenge test), and should not be cleaned during the test. Dispose of the inhaler after each challenge test with Osmohale. The inhaler should not be sterilized or reused, as this may compromise the integrity of the subsequent test results.

……………………………………………………………………………………………………..

Directives for the procedure

STEP 1:Verify that the patient has suspended the following medications (See the table below).

Recommended suspension periods for medications.

The lack of suspension of medications may affect the results of the Osmohale challenge test.

The recommended suspension periods for medications generally depend on their duration of action.

Food:The consumption of significant amounts of coffee, tea, cola drinks, chocolate, or other foods containing caffeine may reduce bronchial reactivity, and should be completely avoided on the day of the study.

Other factors that may affect the results:The day of the test, smoking and vigorous physical exercise should be completely avoided, as they may affect the results.

STEP 2:For the test, the patient should be seated. Explain the procedure, including the requirements for a forced expiratory volume maneuver and the measurement of FEV1, and the type of inspiratory flow required for the inhaler. Demonstrate if necessary.

STEP 3:Enter the patient's data into the spirometer (age, height, race, date of birth, sex, etc.).

STEP 4:Determine the FEV1 before the challenge test.Ask the patient to perform a forced expiratory volume maneuver according to the ATS/ERS guidelines, perform three acceptable maneuvers, of which two are reproduced. Use the highest value as the pre-test FEV1. The patient's FEV1 should be ≥ 70% of the expected value.

Caution should be exercised with patients who have an FEV1 of less than 70% of the expected value.

STEP 5:Calculate the basal FEV1 (0 mg)

a. Remove the 0 mg Osmohale capsule from the blister, open the inhaler (turn it as indicated by the arrow on the device), insert the capsule, and close the device.

b. Perforate the capsule only once, pressing the color buttons on both sides of the inhaler.

c. Ask the patient to put on the nasal clip and breathe through their mouth.

d. Incline the inhaler to 45° (with the mouthpiece pointing downwards). Verify that the capsule has moved from the perforation chamber to the rotating chamber, closer to the mouthpiece.

A sound may be heard as the capsule falls forward, or it may be seen through the holes on both sides of the device. Hand the inhaler to the patient, ensuring it remains at the same angle.

e. Verify that the patient is seated upright. Ask the patient to exhale (outside the inhaler), adjust their lips to the mouthpiece, and take a rapid and deep breath to fill their lungs. During a correct inhalation, you should hear a "cascabel" sound as the capsule rotates inside the device.

f. At the end of the patient's inhalation, start a 60-second timer and ask the patient to hold their breath for 5 seconds. Once the timer sounds, instruct the patient to exhale through their mouth (away from the inhaler), remove the nasal clip, and breathe normally.

g. When the timer sounds at 60 seconds, immediately ask the patient to perform two acceptable FEV1 measurements. These measurements should be within a variability of 0.15 l (150 ml). If the variability between readings is greater than 0.15 l, ask the patient to perform another FEV1 measurement. Record the highest value as the basal FEV1.

h. Compare the FEV1 value with this dose to the FEV1 objective. If the FEV1 value is ≤ the objective value, or if a ≥ 10% incremental drop in FEV1 has occurred since the previous dose, the challenge test is positive and complete. If not, continue immediately with the next dose step.

STEP 6:5 mg capsule

a. Insert the 5 mg capsule into the inhaler and perforate it as indicated in Step 5.

b. Repeat steps 5c – f.

c. After inhalation, remove the capsule from the inhaler and verify that it has been completely emptied; if not, a second inhalation should be performed immediately.

d. After inhalation, load the 10 mg capsule as preparation for the next dose.

e. At 60 seconds after inhalation, immediately measure the patient's FEV1 twice (acceptable criteria should be met). Use the higher of these two values to calculate the FEV1 variability.

f. Compare the FEV1 value with this dose to the FEV1 objective. If the FEV1 value is ≤ the objective value, or if a ≥ 10% incremental drop in FEV1 has occurred since the previous dose, the challenge test is positive and complete. If not, continue immediately with the next dose step.

STEP 7:10 mg, 20 mg, 40 mg capsules

Administer the 10 mg, 20 mg, and 40 mg doses according to the instructions in Step 6 for the 5 mg dose.

STEP 8:80 mg dose (2 x 40 mg capsules)

a. Insert and perforate the first 40 mg capsule that forms the 80 mg dose.

b. The patient should inhale the dose in the same way as the previous doses, hold their breath for 5 seconds, and exhale.

c. Remove the first 40 mg capsule from the device and verify that it has been completely emptied; if not, a second inhalation should be performed immediately. Do this after administering each capsule.

d. After inhalation, load the second 40 mg capsule and offer it to the patient immediately after exhalation.

e. Instruct the patient to inhale the second capsule immediately, to ensure that the osmotic effect of Osmohale is cumulative.

f. Activate the timer at the end of the second capsule inhalation.

g. Instruct the patient to hold their breath for 5 seconds before exhaling.

h. At 60 seconds after the second capsule inhalation, immediately measure the patient's FEV1 twice (acceptable criteria should be met). Use the higher of these two values to calculate the FEV1 variability.

i. Compare the FEV1 value with this dose to the FEV1 objective. If the FEV1 value is ≤ the objective value, or if a ≥ 10% incremental drop in FEV1 has occurred since the previous dose, the challenge test is positive and complete. If not, continue immediately with the next dose step.

STEP 9:First 160 mg dose (4 x 40 mg capsules)

a. Insert and perforate the first 40 mg capsule that forms the 160 mg dose.

b. The patient should inhale the dose in the same way as the previous doses, hold their breath for 5 seconds, and exhale.

c. Remove the capsule from the device and verify that it has been completely emptied; if not, a second inhalation should be performed immediately. Do this after administering each capsule.

d. After inhalation, load the second 40 mg capsule and offer it to the patient immediately after exhalation.

e. The patient should inhale the second capsule, hold their breath for 5 seconds, and exhale.

f. After inhalation, load the third 40 mg capsule and offer it to the patient immediately after exhalation.

g. The patient should inhale the third capsule, hold their breath for 5 seconds, and exhale.

h. After inhalation, load the fourth 40 mg capsule and offer it to the patient immediately after exhalation.

i. Instruct the patient to inhale the fourth capsule immediately, to ensure that the osmotic effect of Osmohale is cumulative.

j. Activate the timer at the end of the fourth capsule inhalation.

k. Instruct the patient to hold their breath for 5 seconds before exhaling.

l. At 60 seconds after the fourth capsule inhalation, immediately measure the patient's FEV1 twice (acceptable criteria should be met). Use the higher of these two values to calculate the FEV1 variability.

m. Compare the FEV1 value with this dose to the FEV1 objective. If the FEV1 value is ≤ the objective value, or if a ≥ 10% incremental drop in FEV1 has occurred since the previous dose, the challenge test is positive and complete. If not, continue immediately with the next dose step.

STEP 10:Second 160 mg dose (4 x 40 mg capsules)

Administer the second 160 mg dose according to the instructions in Step 9.

STEP 11:Third 160 mg dose (4 x 40 mg capsules)

Administer the third 160 mg dose according to the instructions in Step 9.

At the end of this dose, 635 mg will have been administered. If a positive response has not been obtained, the challenge test should be considered complete and negative.

STEP 12:After completing the challenge test, administer a bronchodilator to the patient, and monitor them for 15 minutes to ensure that their FEV1 has returned to within 5% of the pre-test value. (In the case of a negative result, the administration of a bronchodilator is optional).