CTRI/2010/091/000276Completed未知
A randomized, double blind, double dummy four period crossover study to determine the therapeutic equivalence of a test HFA formulation of Salbutamol Sulphate (Azmasol HFA, Beximco Pharma) with the reference HFA formulation of Salbutamol Sulphate (Ventolin Evohaler, supplied by Allen & Hanburys, UK) in subjects with stable mild to moderate asthma.
Callisto Consulting0 sites124 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 124
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Aged 20 to 70 years
- •2. Stable Mild to Moderate Asthmatics for at least 12 months
- •3. Regular use of short-acting inhaled beta-adrenoceptor agonists
- •4. FEV1 values 60 to 80% of predicted values
- •5. Capable of giving Informed Consent
Exclusion Criteria
- •1. Change in treatment of asthma within 4 weeks of start of study
- •2. Treatment with drug which might effect the results of the trial
- •3. Upper Respiratory Tract Infections
- •4. Fixed airways disease
- •5. Inability to use an inhaler correctly or to withhold bronchodilators for 8 hours
- •6. No treatment at Accident & Emergency Unit or Hospital Admission within 1 week of start of study
- •7. Myocardial infarction in the last 3 months
- •8. Uncontrolled Hypertension
- •9. History of Epilepsy
- •10. History of Tuberculosis
- •11. Current smokers or those who have smoked within the last 6 months or those who have a significant smoking history
- •12. Pregnant or lactating women
- •13. Involvement in other clinical trial in last three months
- •Subjects in whom blood drawing is not possible or justifiable in the opinion of Investigator
Investigators
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