Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI; Drug: Buventol® Easyhaler® 200 µg/inhalation dmDPI; Drug: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI

• Registration Number: NCT05084222
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Study Start: 2021-11-11
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ventoline® Evohaler® 100 µg/inhalation pMDI	Ventoline® Evohaler® 100 µg/inhalation pMDI	400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations.
Buventol® Easyhaler® 200 µg/inhalation dmDPI	Buventol® Easyhaler® 200 µg/inhalation dmDPI	400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations.
Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland