A clinical trial to study the effects of Fixed Dose Combinations of Fluticasone Plus Formoterol in patients with Asthma.

Phase 3

Completed

• Conditions: Asthma

• Registration Number: CTRI/2012/02/002405
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

This is a randomized, open–label, comparative, non-Inferiority, multicenteric study. The study will be conducted in adolescent and adult patients with a diagnosis of Moderate-Severe Persistent Asthma with an FEV1 of ≥40% to < 80% of the predicted value. Study will enroll 372 patients across different centers from 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 FDC of Fluticasone 250 μg Plus Formoterol 12 μg as DPI (capsules)  or Fluticasone 250 μg (Fluticap 250 μg)  Plus Formoterol 12 μg (Foradil 12  μg) delivered via separate DPI’s.

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, number of asthma exacerbations, average need for use of short acting β 2 agonists 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: 2012-06-02
• Last Update Posted: 2013-07-06

Recruitment & Eligibility

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

Inclusion Criteria

• The patient and/or legally accepted representative (LAR) provides written informed consent to participate in the study.
• Male or female patient aged between 16 to 70 years with known history of moderate-severe persistent, reversible asthma for ≥ 6 months.
• FEV1 between ≥40% to < 80% of the predicted value.
• Patient willing to perform all study related procedures including the use of study inhalers, spirometer and peak flow meter 5.
• Positive response to the reversibility test.
• Females of child bearing age must have a negative pregnancy test at screening visit, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study.

Exclusion Criteria

• Inability to carry out pulmonary function testing 2.
• Significant, non-reversible, active pulmonary disease 3.
• Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients 4.
• History of near fatal asthma within the past one year 5.
• Evidence of severe asthma exacerbation or upper or lower respiratory tract infections within the past 4 weeks 6.
• Active smoker 7.
• Subjects who are using any medication or have 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.
• History of uncontrolled Diabetes mellitus 10.
• Clinically significant ECG Abnormality at baseline 11.
• Use of prohibited medication 12.
• Patients who received any investigational new drug within the last 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean difference between groups in FEV1 value at the End of Treatment Visit	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in morning PEF	12 weeks
Change in asthma symptom score	12 weeks
Number of asthma exacerbations	12 weeks
Change in evening PEF	12 weeks
Change in Diurnal variability of PEF	12 weeks
Change in nocturnal asthma symptom	12 weeks
Average need for use of short acting β 2 agonists	12 weeks

Trial Locations

Locations (10)

Aswini Hospital; 🇮🇳 Warangal, ANDHRA PRADESH, India

Chest Asthma and Allergy Clinic; 🇮🇳 Kolkata, WEST BENGAL, India

Karthick Poly Clinic; 🇮🇳 Coimbatore, TAMIL NADU, India

Mahatma Gandhi Medical College & Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Medical College , Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

National Allergy Asthma Bronchitis Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Pace Clinical Research; 🇮🇳 Bangalore, KARNATAKA, India

Shwass Center, Navkar Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

St. Theresas Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Sudha Lung Care and Research Centre; 🇮🇳 Salem, TAMIL NADU, India

Aswini Hospital

🇮🇳Warangal, ANDHRA PRADESH, India

Dr V Nagaeshwar

Principal investigator

9949529392

doctor4lungs@gmail.com