Clinical Trials Directory

Trials / Completed

CompletedNCT05084222

Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

Use of Buventol Easyhaler and Bufomix Easyhaler as Relievers in Methacholine Challenge Testing and Inspiratory Flow Profiles During Induced Bronchoconstriction in Adult Subjects

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
180 (actual)
Sponsor
Orion Corporation, Orion Pharma · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGBuventol® Easyhaler® 200 µg/inhalation dmDPITwo doses will be administered
DRUGBufomix® Easyhaler® 160/4.5 µg/inhalation dmDPITwo doses will be administered
DRUGVentoline® Evohaler® 100 µg/inhalation pMDIFour doses will be administered via Volumatic spacer

Timeline

Start date
2021-11-11
Primary completion
2023-06-30
Completion
2023-06-30
First posted
2021-10-19
Last updated
2023-09-05

Locations

2 sites across 1 country: Finland

Source: ClinicalTrials.gov record NCT05084222. Inclusion in this directory is not an endorsement.