A clinical trial to study and compare the pharmacokinetic and pharmacodynamic effects of two dry powder inhaler devices, test and reference containing Salmeterol 25mcg and fluticasone propionate 250mcg with salmeterol 50mcg and fluticasone propionate 500mcg in patients with severe asthma.

Phase 1/2

Completed

• Conditions: Other and unspecified asthma,

• Registration Number: CTRI/2013/08/003878
• Lead Sponsor: Sun Pharma Advanced Research Company Ltd

Brief Summary

The study was conducted to to monitor the safety of the subjects participating in the study and to assess the comparative pharmacokinetic & pharmacodynamic of Salmeterol 25mg + Fluticasone Propionate 250mg Inhalation Powder (SUN DPI) of Sun Pharma Advanced Research Company Limited, India and SeretideTM Diskus 50/500 (Salmeterol 50mg + Fluticasone Propionate 500mg) Inhalation Powder of GlaxoSmithKline in moderate to severe asthmatic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-20
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Eighteen years or older moderate to severe asthmatic subjects with weight at least 50 kg and BMI between 18.5-3.0 kg/m2 subjects who are willing to sign written consent form prior to study entry subjects with clinically acceptable results from the screening procedure including blood pressure, pulse rate, 12-lead ECG, x-ray, physical examination, medical history, hematology, biochemistry, urinalysis and infection screen (Hepatitis C Antibody, HIV) Diagnosis of asthma.

Exclusion Criteria

• Subjects with a history of clinically significant gastrointestinal, dermatological, cardiovascular, renal, hematological, psychiatric, cerebrovascular, neurological, hepatic, pulmonary (significant respiratory disease other than asthma), or endocrine disease in the last 12 months; Allergy or Significant history of hypersensitivity or idiosyncratic reactions to fluticasone and/ or salmeterol, milk proteins and /or any related compounds etc; Subjects determined by the study physician to have any medical condition that could jeopardize their health or prejudice the results.
• (E.g. history of surgery of the gastro-intestinal tract, which may interfere with absorption, except for appendectomy); Females who are pregnant, breastfeeding, or are likely to become pregnant; Subjects with any clinically significant illness (including respiratory illness) within 4 weeks prior to Period 1 dosing, and Diagnosis of COPD.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax,AUC, Tmax, t½	1h predose, 1min, 3min, 5min, 10min, 30min, 60min, 90min, 2h, 3h, 4h, 8h, 12h and 36h postdose

Secondary Outcome Measures

Name	Time	Method
Safety parameters	at pre-dose and1, 2, 4 and 12 hours post-dose

Trial Locations

Locations (1)

Meridian Hospital; 🇮🇳 Vadodara, GUJARAT, India

Meridian Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Mallika Khanna

Principal investigator

mallikakhanna06@gmail.com