Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

Asthma Clinical Trial

— EASYRELIEF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05084222
• Other study ID #: 0010032
• Status: Completed
• Phase: Phase 4
• Start date: November 11, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-agonists within 12 h
• Long-acting ß-agonists within 36 h
• Ultra-long-acting ß-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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Buventol® Easyhaler® 200 µg/inhalation dmDPI
Two doses will be administered
• Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI
Two doses will be administered
• Ventoline® Evohaler® 100 µg/inhalation pMDI
Four doses will be administered via Volumatic spacer

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients needing medical attention	Proportion of subjects needing medical attention after study treatment	After study treatment administration until study completion (an average of 2.5 hours)
Other	Inhalation profile via Easyhaler	Time-inspiratory flow -curve via Easyhaler measured with spirometer.	Before methacholine challenge and 10 minutes after the subject experiences FEV1 drop = 20% compared to post-diluent spirometry
Primary	Forced expiratory volume in one second (FEV1)	Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever.	10 minutes
Secondary	Number of subjects who recover from bronchoconstriction after first dose	Proportion of the subjects who recover to FEV1 > -10% compared to post-diluent FEV1 after first dose of reliever.	10 minutes
Secondary	Forced expiratory volume in one second (FEV1)	Relative recovery of FEV1 after the study treatment dosing when compared to post-diluent FEV1.	10 minutes
Secondary	Number of subjects who recover from bronchoconstriction after second dose	Proportions of subjects reaching FEV1 > -10% of post-diluent value after second dose of reliever.	20 minutes