Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

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.