A Phase 4 interventional study of Buventol® Easyhaler® 200 µg/inhalation dmDPI and Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI in Asthma, sponsored by Orion Corporation, Orion Pharma. Completed at 2 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Orion Corporation, Orion Pharma · Phase 4, Interventional, and Treatment
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.
Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects not eligible for methacholine challenge test for example for any of the following reasons:
Subjects who have used the following treatments before the study visit:
400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations.
Drug: Buventol® Easyhaler® 200 µg/inhalation dmDPI
320 μg of budesonide and 9 μg of formoterol are administered from Bufomix Easyhaler as two inhalations.
Drug: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI
400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations.
Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI
Two doses will be administered
Also known as: Salbutamol 200 µg/dose dmDPI
Two doses will be administered
Also known as: Budesonide/formoterol 160/4.5 µg/inhalation dmDPI
Four doses will be administered via Volumatic spacer
Also known as: Salbutamol 100 µg/dose MDI
Forced expiratory volume in one second (FEV1)
Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever.
Time frame: 10 minutes
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.
Time frame: 10 minutes
Forced expiratory volume in one second (FEV1)
Relative recovery of FEV1 after the study treatment dosing when compared to post-diluent FEV1.
Time frame: 10 minutes
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.
Time frame: 20 minutes
Number of patients needing medical attention
Proportion of subjects needing medical attention after study treatment
Time frame: After study treatment administration until study completion (an average of 2.5 hours)
Inhalation profile via Easyhaler
Time-inspiratory flow -curve via Easyhaler measured with spirometer.
Time frame: Before methacholine challenge and 10 minutes after the subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry
Plan to share: No
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Orion Corporation, Orion Pharma