Clinical trial NCT05084222: Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing
Official title: Use of Buventol Easyhaler and Bufomix Easyhaler as Relievers in Methacholine Challenge Testing and Inspiratory Flow Profiles During Induced Bronchoconstriction in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 10 minutes
Secondary outcomes:
measure: Number of subjects who recover from bronchoconstriction after first dose
timeFrame: 10 minutes
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 10 minutes
measure: Number of subjects who recover from bronchoconstriction after second dose
timeFrame: 20 minutes
Other outcomes:
measure: Number of patients needing medical attention
timeFrame: After study treatment administration until study completion (an average of 2.5 hours)
measure: Inhalation profile via Easyhaler
timeFrame: Before methacholine challenge and 10 minutes after the subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital, Finland
name: Lauri Lehtimäki
role: PRINCIPAL_INVESTIGATOR
References: