CompletedPhase 4

Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

Finland180 participantsStarted 2021-11-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent (IC) obtained.
✓. Finnish speaking adult (≥ 18 years old) subject indicated for methacholine challenge test.
✓. The subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry.

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:
✕. 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).
✕. Administration of another investigational medicinal product within 30 days before the study visit.

What they're measuring

Forced expiratory volume in one second (FEV1)

Timeframe: 10 minutes

Trial details

NCT IDNCT05084222

SponsorOrion Corporation, Orion Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-30

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