A randomized, double blind, double dummy four period crossover study to determine/ compare effectiveness of two different Salbutamol sulphate formulations manufactured by Beximco pharma & Allen Hanburys respectively in subjects with mild to moderate asthma.

Not Applicable

Completed

Registration Number: CTRI/2010/091/000276

Lead Sponsor: Callisto Consulting

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 124

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the therapeutic equivalence of Azmasol HFA with Ventolin EvohalerTimepoint: Spirometric evaluation at 5, 15, 30, 45, 60, 120, 240 and 360 post dose

Secondary Outcome Measures

Name	Time	Method
1. To demonstrate a difference between the 100 and 200 mcg doses for each product <br/ ><br>2. To demonstrate the change in FVC <br/ ><br>3. To compare the safety of the test product to the reference productTimepoint: - FEV1 and FVC measured post <br/ ><br>dose at 5, 15, 30, 45, 60, 120, 240 and 360 minutes <br/ ><br>- Safety measures will be assessed at 15 minute intervals <br/ ><br>for the first hour then hourly till 6 hours post dose <br/ ><br>- Blood sample will be collected pre dose within 1 hr and at 3 hrs post dose to measure the serum potassium and plasma glucose levels