CTRI/2011/11/002161 [Registered on: 23/11/2011] Trial Registered Prospectively
Last Modified On:
31/12/2012
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the effects of Salmeterol/Fluticasone in patients with Persistent Asthma.
Scientific Title of Study
A Phase III, Randomized, Open Label, Non- Inferiority, Comparative, Multicentric Study Between HFA-Propelled Salmeterol/Fluticasone (25/250μg) pMDI And HFA-Propelled Seretide® (25/250μg) pMDI In Patients With Persistent Asthma
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GL-SF/2011-12
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
17 A/3 Patrika Marg, Civil Line Allahabad UTTAR PRADESH
9415214339
tandona21@gmail.com
Dr Shilpa Karande
TN Medical college, BYL Nair hospital
Department of Medicine, 1st Floor, Room no.104, College Building, T.N.Medical College & BYL Nair Charitable Hospital
Dr. A. L. Nair Road. Mumbai Central (E) Mumbai MAHARASHTRA
9819854135
drshilpapvk@yahoo.co.in
Dr Ravindra Sanglikar
Vedant multispecialty hospital and research centre
1. 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.
6. 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.
ExclusionCriteria
Details
1. 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
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
The mean difference between groups in Forced Expiratory Volume in 1 second (FEV1) value at the End of Treatment Visit
12 weeks
Secondary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="372" Sample Size from India="372" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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 India.
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.