EASYRELIEF: Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Buventol® Easyhaler® 200 µg/inhalation dmDPI 400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations. |
Drug: Buventol® Easyhaler® 200 µg/inhalation dmDPI
Two doses will be administered
Other Names:
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Experimental: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI 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
Two doses will be administered
Other Names:
|
Active Comparator: Ventoline® Evohaler® 100 µg/inhalation pMDI 400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations. |
Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI
Four doses will be administered via Volumatic spacer
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent (IC) obtained.
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Finnish speaking adult (≥ 18 years old) subject indicated for methacholine challenge test.
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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:
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Any respiratory infection within 2 weeks, or severe respiratory infection within 4 weeks before the study visit
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FEV1 < 60% of predicted or < 1.0 l
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Inability to perform acceptable and repeatable spirometry manoeuvres throughout the test procedure
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Uncontrolled hypertension
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Acute chest pain or unstable angina pectoris
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Significant cardiac arrhythmias
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Pneumothorax or recent bronchoscopy
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Myocardial infarction or stroke in last 3 months
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Known aortic aneurysm
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Recent eye surgery or intracranial pressure elevation risk
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Cholinesterase inhibitor medication
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Pregnant or lactating females
- Subjects who have used the following treatments before the study visit:
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Short-acting β-agonists within 12 h
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Long-acting β-agonists within 36 h
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Ultra-long-acting β-agonists within 48 h
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Long-acting anti-muscarinic agents within 168 h
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Short-acting anticholinergics within 12 h
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Oral theophylline within 24 h
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Inhaled corticosteroids, leukotriene receptor antagonists and chromones within 4 weeks
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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).
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Administration of another investigational medicinal product within 30 days before the study visit.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tampere University Hospital | Tampere | Finland | 33520 |
Sponsors and Collaborators
- Orion Corporation, Orion Pharma
Investigators
- Study Director: Iissa Kivistö, Orion Pharma, Espoo, Finland
- Principal Investigator: Lauri Lehtimäki, Tampere University Hospital, Finland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0010032