A clinical trial to study the effects of Salmeterol/Fluticasone in patients with Persistent Asthma.

Phase 3

Completed

• Conditions: Persistent Asthma

• Registration Number: CTRI/2011/11/002161
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

This is a randomized, open–label, comparative, non-Inferiority, multicenteric study. The study will be conducted in patients with a diagnosis of persistent asthma with an FEV1 of 50% to 80% of the predicted value. Study will enroll 372 patients across different centers from xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Patients will be recruited after providing written informed consent. After screening and run in period, patient will be randomized (patient meeting randomization criteria) in 1:1 ratio to receive either HFA-Propelled Salmeterol/Fluticasone pMDI or HFA Propelled Seretide® pMDI.

The primary objective of the study is to evaluate the effect of study drug on lung function as assessed by FEV1 after the therapy (12 weeks). Secondary objective includes Change in PEF, asthma symptoms, patient / investigator’s global assessments and safety. Patients will be followed for safety and efficacy assessment at week 4, 8 and 12 after start of therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-12
• Last Update Posted: 2012-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

• The patient provides written informed consent to participate in the study 2.
• Male or female patient aged ≥12 years 3.
• Documented diagnosis of asthma 4.
• FEV1 between 50% and 80% of the predicted value 5.
• Patient willing to perform all study related procedures including the use of study inhalers, spirometer and peak flow meter.
• Female participants must have a negative pregnancy test at screening visit and willing to use acceptable contraceptive measures during the study.
• Males must agree to use barrier contraception while on study medication and for 90 days after taking the last dose of study medication.

Exclusion Criteria

• Patient with Chronic Obstructive Pulmonary Disease (COPD) 2.
• Pregnant or lactating women 3.
• Patients with a history of hypersensitivity to Salmeterol/Fluticasone and/or any other ingredients 4.
• History of Asthma exacerbation and hospitalization needed due to asthma within the last 3 months prior to the study 5.
• Patients diagnosed with Intermittent, seasonal or exercise Induced Asthma 6.
• Patients with active smoking 7.
• Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study 8.
• Clinically significant cardiovascular, haematological, endocrine, neurological, gastrointestinal, psychiatric, metabolic, immunologic, infectious, hepatic, renal, gynaecological disease or other condition that the investigator considers detrimental to the patient’s participation in the study or that may prevent the successful completion of the study 9.
• Clinically significant ECG Abnormality at baseline 10.
• Patients with documented or suspected or current history of alcohol and drug abuse 11.
• Patients who have undergone major surgery in the previous 4 weeks 12.
• Participation in an investigational drug trial within 3 months of screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean difference between groups in Forced Expiratory Volume in 1 second (FEV1) value at the End of Treatment Visit	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change over the weeks in morning PEF	12 weeks
Change over the weeks in evening PEF	12 weeks
Change in asthma symptom score	12 weeks
Change in nocturnal asthma symptom score	12 weeks
Investigator global impression	12 weeks
Patient global impression	12 weeks

Trial Locations

Locations (29)

Centre for Chest Diseases, Allergy & Sleep Disorder; 🇮🇳 Delhi, DELHI, India

Chintamani Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Coimbatore Chest Clinic; 🇮🇳 Coimbatore, TAMIL NADU, India

Cosmopolitan Medical Center; 🇮🇳 Bangalore, KARNATAKA, India

Criticare Multispecialty Hospital and Research Center; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. Mukesh Jain’s Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Fortis Escorts Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Giriraj Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Jeevanrekha Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

KIMS (Krishna Institute of Medical Sciences); 🇮🇳 Hyderabad, ANDHRA PRADESH, India

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Centre for Chest Diseases, Allergy & Sleep Disorder

🇮🇳Delhi, DELHI, India

Dr Animesh Arya

Principal investigator

011-25269552

dranimesharya@hotmail.com