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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Two doses will be administered
Two doses will be administered
Four doses will be administered via Volumatic spacer
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
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
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