Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

Study Overview
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Brief Summary
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The study compares Buventol® Easyhaler® and Bufomix® Easyhaler® to the current standard treatment during methacholine challenge test. The trial will also provide inspiratory flow profile data for Easyhaler inhaler. This trial is designed to provide a further evidence for the use of Easyhaler in diagnostic bronchial challenge tests and on the use of Easyhaler inhaler during obstructive event.

Official Title
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Use of Buventol Easyhaler and Bufomix Easyhaler as Relievers in Methacholine Challenge Testing and Inspiratory Flow Profiles During Induced Bronchoconstriction in Adult Subjects

Conditions
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Asthma

Intervention / Treatment
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* Drug: Buventol® Easyhaler® 200 µg/inhalation dmDPI
* Drug: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI
* Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent (IC) obtained. Finnish speaking adult (≥ 18 years old) subject indicated for methacholine challenge test. The subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry. Exclusion Criteria: Subjects not eligible for methacholine challenge test for example for any of the following reasons: Any respiratory infection within 2 weeks, or severe respiratory infection within 4 weeks before the study visit FEV1 < 60% of predicted or < 1.0 l Inability to perform acceptable and repeatable spirometry manoeuvres throughout the test procedure Uncontrolled hypertension Acute chest pain or unstable angina pectoris Significant cardiac arrhythmias Pneumothorax or recent bronchoscopy Myocardial infarction or stroke in last 3 months Known aortic aneurysm Recent eye surgery or intracranial pressure elevation risk Cholinesterase inhibitor medication Pregnant or lactating females Subjects who have used the following treatments before the study visit: Short-acting β-agonists within 12 h Long-acting β-agonists within 36 h Ultra-long-acting β-agonists within 48 h Long-acting anti-muscarinic agents within 168 h Short-acting anticholinergics within 12 h Oral theophylline within 24 h Inhaled corticosteroids, leukotriene receptor antagonists and chromones within 4 weeks Known hypersensitivity to the active substance(s) or the excipients of the study treatments (for example severe milk allergy, lactose contains small amounts of milk protein). Administration of another investigational medicinal product within 30 days before the study visit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buventol® Easyhaler® 200 µg/inhalation dmDPI<br>400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations. | Drug: Buventol® Easyhaler® 200 µg/inhalation dmDPI<br>* Two doses will be administered<br>* Other names: Salbutamol 200 µg/dose dmDPI;|
| Experimental: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI<br>320 μg of budesonide and 9 μg of formoterol are administered from Bufomix Easyhaler as two inhalations. | Drug: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI<br>* Two doses will be administered<br>* Other names: Budesonide/formoterol 160/4.5 µg/inhalation dmDPI;|
| Active Comparator: Ventoline® Evohaler® 100 µg/inhalation pMDI<br>400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations. | Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI<br>* Four doses will be administered via Volumatic spacer<br>* Other names: Salbutamol 100 µg/dose MDI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in one second (FEV1) | Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who recover from bronchoconstriction after first dose | Proportion of the subjects who recover to FEV1 > -10% compared to post-diluent FEV1 after first dose of reliever. | 10 minutes | 
| Forced expiratory volume in one second (FEV1) | Relative recovery of FEV1 after the study treatment dosing when compared to post-diluent FEV1. | 10 minutes | 
| Number of subjects who recover from bronchoconstriction after second dose | Proportions of subjects reaching FEV1 > -10% of post-diluent value after second dose of reliever. | 20 minutes |