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Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3

NCT02322788 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2017-01-13

Study results available
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Summary

A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma

Conditions

Interventions

DRUG

Terbutaline sulphate

Bricanyl Turbuhaler M2

DRUG

Terbutaline sulphate

Bricanyl Turbuhaler M3

DRUG

Placebo for terbutaline sulphate

Placebo Turbuhaler M2

DRUG

Placebo for terbutaline sulphate

Placebo Turbuhaler M3

Sponsors & Collaborators

Principal Investigators

  • Göran Eckerwall, MD · AstraZeneca Mölndal, Sweden

  • Leif Bjermer, MD, Professor · Skånes University hospital, Lund

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Canada
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02322788 on ClinicalTrials.gov