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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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221094
Enrollment
Unknown
Registered
2010-05-12
Start date
2010-05-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

investigational material(s) Generic name etc : Terbutaline Turbuhaler INN of investigational material : Therapeutic category code : 225 Bronchodilators Dosage and Administration for Investigational m

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026