A clinical trial to study fixed dose combination of Formoterol fumarate & Mometasone furoate dry powder inhaler and fixed dose combination of Formoterol fumarate & Budesonide dry powder inhaler in patients with bronchial asthma and/or chronic obstructive pulmonary disease (COPD).

Phase 3

Completed

• Conditions: Health Condition 1: null- Bronchial asthma and/or chronic obstructive pulmonary disease (COPD)Health Condition 2: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 3: J459- Other and unspecified asthma

• Registration Number: CTRI/2009/091/000111
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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 lactation
2.Patients with severe or recently unstable bronchial asthma or status asthmaticus
3.Patients requiring nebulized therapy or oral corticosteroids
4.Patients with active or quiescent tuberculosis infection, glaucoma, untreated systemic fungal, bacterial, viral or parasitic infections or ocular herpes simplex
5.Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment
6.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 study
7.Patients with history of known hypersensitivity to formoterol fumarate or mometasone furoate or budesonide or salbutamol or any component of the formulations
8.Patients with any other serious concurrent illness or malignancy
9.Patients with continuing history of alcohol and/or drug abuse
10.Participation in another clinical trial in the past 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified