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.

A randomized, open label, two treatment, two period, two sequence, single dose, crossover, comparative pharmacokinetic & pharmacodynamic study of salmeterol 25 mcg and fluticasone propionate 250 mcg inhalation powder (SUN DPI) of Sun Pharma Advanced Research Company Limited, India and seretidetm diskus 50/500 (salmeterol 50mcg and fluticasone propionate 500mcg) inhalation powder of Glaxosmithkline in moderate to severe asthmatic patients.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/08/003878

Enrollment

Registered

2013-08-05

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

Health Condition 1: null- moderate to severe asthmatic patients Health Condition 2: J459- Other and unspecified asthma

Interventions

Intervention1: SUN DPI: Salmeterol 25 mcg + fluticasone propionate 250 mcg Duration of therapy: one day Control Intervention1: Seretide Diskus (GSK): Salmeterol 50 mcg + fluticasone propionate 500 mcg

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Cmax,AUC, Tmax, tÂ½ Timepoint: 1h predose, 1min, 3min, 5min, 10min, 30min, 60min, 90min, 2h, 3h, 4h, 8h, 12h and 36h postdose	—

Secondary

Measure	Time frame
Safety parametersTimepoint: at pre-dose and1, 2, 4 and 12 hours post-dose	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Ltd.

clinical.trials@sparcmail.com02266455645

Outcome results

None listed

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