Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

NCT ID: NCT05084222

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2023-06-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Buventol® Easyhaler® 200 µg/inhalation dmDPI

400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations.

Group Type: EXPERIMENTAL

Buventol® Easyhaler® 200 µg/inhalation dmDPI

Intervention Type: DRUG

Two doses will be administered

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.

Group Type: EXPERIMENTAL

Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI

Intervention Type: DRUG

Two doses will be administered

Ventoline® Evohaler® 100 µg/inhalation pMDI

400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations.

Group Type: ACTIVE_COMPARATOR

Ventoline® Evohaler® 100 µg/inhalation pMDI

Intervention Type: DRUG

Four doses will be administered via Volumatic spacer

Interventions

Buventol® Easyhaler® 200 µg/inhalation dmDPI

Two doses will be administered

Intervention Type: DRUG

Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI

Two doses will be administered

Intervention Type: DRUG

Ventoline® Evohaler® 100 µg/inhalation pMDI

Four doses will be administered via Volumatic spacer

Intervention Type: DRUG

Other Intervention Names

Salbutamol 200 µg/dose dmDPI; Budesonide/formoterol 160/4.5 µg/inhalation dmDPI; Salbutamol 100 µg/dose MDI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauri Lehtimäki

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital, Finland

Locations

Helsinki University Hospital

Helsinki, , Finland

Tampere University Hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

0010032

Identifier Type: -

Identifier Source: org_study_id