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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000276
Enrollment
124
Registered
2010-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Azmasol HFA: Salbutamol Sulphate (100 mcg and 200 mcg) Control Intervention1: Ventolin Evohaler: Salbutamol Sulphate (100 mcg and 200 mcg)

Sponsors

Callisto Consulting
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. To demonstrate a difference between the 100 and 200 mcg doses for each product 2. To demonstrate the change in FVC 3. To compare the safety of the test product to the reference productTimepoint: - FEV1 and FVC measured post dose at 5, 15, 30, 45, 60, 120, 240 and 360 minutes - Safety measures will be assessed at 15 minute intervals for the first hour then hourly till 6 hours post dose - 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—

Countries

India

Contacts

Public ContactDr Sujala Pathare

Manipal Acunova

nagendra.n@ecronacunova.com91-80-66915780

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026