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)

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2009
INTERVENTION: Intervention1: Fixed‐dose combination of Formoterol fumarate (6 µg) & Mometasone furoate (200 µg) respicaps for Dry Powder Inhaler (DPI): Two respicaps BD Control Intervention1: Fixed‐dose combination of Formoterol fumarate (6 µg) & Budesonide (200 µg) respicaps for Dry Powder Inhaler (DPI): Two respicaps BD CONDITION: Bronchial asthma and/or chronic obstructive pulmonary disease (COPD) PRIMARY OUTCOME: The degree of improvement in PEFR at each visit and at the end of the study as compared to baseline‐‐‐‐‐‐Timepoint: 1‐4 weeks SECONDARY OUTCOME: 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‐‐‐‐‐‐Timepoint: 1‐4 weeks 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
Epistemonikos ID: ee127dc8e86de39cbe35d3bde2a7088aac491cd7
First added on: Aug 22, 2024