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

A Randomised, Double-Blind, Double-Dummy, Parallel Group, Multicentre Study to Compare the Efficacy and Tolerability of HFA-Propelled Combination Fluticasone Propionate 125 mcg and Salmeterol Xinafoate 25 mcg pMDI with Separate HFA Propelled Fluticasone Propionate 125 mcg pMDI and CFC-Propelled Salmeterol Xinafoate 25 mcg pMDI in Subjects with Mild to Moderate Asthma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003029

Enrollment

352

Registered

2010-12-13

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

Health Condition 1: null- Asthma

Interventions

Intervention1: Fluticasone/salmeterol HFA pMDI: 2 puffs b.i.d for 12 weeks Control Intervention1: Fluticasone HFA pMDI + salmeterol CFC pMDI both taken concurrently: 2 puffs b.i.d from each inhaler

Eligibility

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
Mean morning PEFRTimepoint: Baseline and 3, 6, 9 and 12 weeks after randomization	—

Secondary

Measure	Time frame
? FEV1 ? Forced expiratory flow at 25% and 75% ? Interference of asthma symptoms with daytime activities and sleep. ? Number of administrations of rescue medication. ? Overall assessment of efficacy by investigator. Timepoint: Baseline and 3, 6, 9 and 12 weeks after randomization	—

Countries

India

Contacts

Public ContactDr. Purandare

Cipla Ltd

jgogtay@cipla.com9122-23082891

Outcome results

None listed

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