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Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

NCT05084222 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-09-05

No results posted yet for this study

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

DRUG

Buventol® Easyhaler® 200 µg/inhalation dmDPI

Two doses will be administered

DRUG

Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI

Two doses will be administered

DRUG

Ventoline® Evohaler® 100 µg/inhalation pMDI

Four doses will be administered via Volumatic spacer

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Lauri Lehtimäki · Tampere University Hospital, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Finland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05084222 on ClinicalTrials.gov