Asthma
Conditions
Brief summary
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.
Interventions
DRUGBuventol® Easyhaler® 200 µg/inhalation dmDPI
Two doses will be administered
DRUGBufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI
Two doses will be administered
DRUGVentoline® Evohaler® 100 µg/inhalation pMDI
Four doses will be administered via Volumatic spacer
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent (IC) obtained. 2. Finnish speaking adult (≥ 18 years old) subject indicated for methacholine challenge test. 3. The subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry.
Exclusion criteria
1. 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 2. 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 3. 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). 4. Administration of another investigational medicinal product within 30 days before the study visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | 10 minutes | Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects who recover from bronchoconstriction after first dose | 10 minutes | Proportion of the subjects who recover to FEV1 \> -10% compared to post-diluent FEV1 after first dose of reliever. |
| Forced expiratory volume in one second (FEV1) | 10 minutes | Relative recovery of FEV1 after the study treatment dosing when compared to post-diluent FEV1. |
| Number of subjects who recover from bronchoconstriction after second dose | 20 minutes | Proportions of subjects reaching FEV1 \> -10% of post-diluent value after second dose of reliever. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients needing medical attention | After study treatment administration until study completion (an average of 2.5 hours) | Proportion of subjects needing medical attention after study treatment |
| Inhalation profile via Easyhaler | Before methacholine challenge and 10 minutes after the subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry | Time-inspiratory flow -curve via Easyhaler measured with spirometer. |
Countries
Finland
Outcome results
None listed