An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination of Formoterol fumarate & Mometasone furoate Dry Powder Inhaler DPI and fixed-dose combination of Formoterol fumarate & Budesonide Dry Powder Inhaler (DPI) for the treatment of bronchial asthma and or COPD.

Cadila Healthcare Ltd5 sites in 1 country200 target enrollmentStarted: September 3, 2009Last updated: November 13, 2018

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: Cadila Healthcare Ltd
Enrollment: 200
Locations: 5
Primary Endpoint: The degree of improvement in PEFR at each visit and at the end of the study as compared to baseline

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination of Formoterol fumarate & Mometasone furoate Dry Powder Inhaler (DPI) and fixed-dose combination of Formoterol fumarate & Budesonide Dry Powder Inhaler (DPI) two respicaps twice daily each in 200 patients with bronchial asthma and/or chronic obstructive pulmonary disease (COPD) that will be conducted in India. The primary outcome measures will be degree of improvement in PEFR at each visit and at the end of the study as compared to baseline.

Study Design

Study Type: Interventional
Allocation: Computer generated randomization
Masking: Open Label

Eligibility Criteria

Ages: 18.00 Year(s) to 65.00 Year(s) (—)
Sex: All

Inclusion Criteria

•1.Patients between 18-65 years of age 2.Patients with an established diagnosis of bronchial asthma and/or chronic obstructive pulmonary disease (COPD) requiring a combination of long acting beta 2-agonists and inhalation corticosteroids 3.Informed consent of the patient/relative.

Exclusion Criteria

•1.Pregnancy and/or lactation2.Patients with severe or recently unstable bronchial asthma or status asthmaticus3.Patients requiring nebulized therapy or oral corticosteroids4.Patients with active or quiescent tuberculosis infection, glaucoma, untreated systemic fungal, bacterial, viral or parasitic infections or ocular herpes simplex5.Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment6.Patients with any significant disease of any other organ system (renal, hepatic, cardiovascular, neurologic etc.) that could interfere with the study or require treatment which might interfere with the study7.Patients with history of known hypersensitivity to formoterol fumarate or mometasone furoate or budesonide or salbutamol or any component of the formulations8.Patients with any other serious concurrent illness or malignancy9.Patients with continuing history of alcohol and/or drug abuse10.Participation in another clinical trial in the past 3 months.

Outcomes

Primary Outcomes

The degree of improvement in PEFR at each visit and at the end of the study as compared to baseline

Time Frame: 1-4 weeks

Secondary Outcomes

The degree of improvement in the day-time and the night-time asthma symptoms (cough, wheeze, chest tightness, and shortness of breath) score as assessed on a 4-point scale as mentioned above at each visit and at the end of the study as compared to baseline(1-4 weeks)

Investigators

Sponsor

Cadila Healthcare Ltd

Sponsor Class

Pharmaceutical industry-Indian

Study Sites (5)

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