This clinical trial compared the efficacy and safety of the combination inhaled drug of fluticasone/salmeterol versus fluticasone and salmeterol given concurrently in asthma patients

Phase 4

Completed

• Conditions: Health Condition 1: null- Asthma

• Registration Number: CTRI/2010/091/003029
• Lead Sponsor: Cipla Ltd, Mumbai Central, Mumbai ? 400 008, India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 352

Inclusion Criteria

INCLUSION CRITERIA: Suitable subjects were of either sex; aged 18 to 65 years with a confirmed diagnosis of mild to moderate asthma and using ICS less than 400 & 800 mcg of beclometasone dipropionate (BDP) or equivalent per day for at least 4 weeks prior to the screening visit. Symptomatic subjects also demonstrated a prebronchodilator forced expiratory volume in one second (FEV1) greater than 60% and less than 90%

of the predicted normal value when not taking short-acting bronchodilator medication, and were able to demonstrate a greater than 12% improvement in FEV1 within 15-30 minutes after inhalation of salbutamol unless reversibility had been documented in the previous 12 months. All subjects gave written, informed consent and were, in the opinion of the investigator, able to comply with the requirements of the protocol.

Exclusion Criteria

EXCLUSION CRITERIA:
Subjects were excluded from the study if they had a daily requirement for >800 mcg BDP or equivalent, admission to hospital for treatment of asthma within 4 weeks preceding the screening visit; or had received more than 4 short courses of oral corticosteroids within the year preceding the screening visit; or any oral corticosteroids in the preceding 4 weeks. Subjects were also excluded if they had any clinically relevant medical condition that might compromise the safety of the subject or that in itself, or by its treatment, might interfere with the efficacy results of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified