A Study to Investigate the Relative Efficacy of Terbutaline Turbuhaler 0.4 mg and Salbutamol pMDI 200mcg - a Single Blind, Single Dose, Randomized, Crossover, Phase 3 Study in Japanese Adult Asthma Patients

Phase 3

• Conditions: Asthma

• Registration Number: JPRN-jRCT2080221094
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

On ICS for at least 3 months from Visit 2 and with a prescribed constant dose during the 4 weeks prior to Visit 2

- FEV1 of at least 50 % of predicted normal value pre-bronchodilator

- Reversible airway obstruction according to reversibility test performed at Visit 2, defined as an increase in FEV1 12% or more relative baseline at 15-30 minutes after inhalation of in total 400mcg salbutamol

Exclusion Criteria

- Treatment with oral, parenteral or rectal GCS within 4 weeks or depot parenteral GCS within 3 months prior to Visit 2.

- Change in prescribed asthma medication due to exacerbation of asthma within 4 weeks prior to Visit 2 or being hospitalized due to exacerbation of asthma within 8 weeks prior to Visit 2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified