Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: FDC of Formoterol Fumarate and Budesonide inhalation capsule (12µg + 400µg): 1 capsule to be inhaled two times daily, for 12 weeks
Control Intervention1: Alenia® (FDC of Formoterol 1
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients aged >=12 to 2. Clinical diagnosis of asthma for at least 6 months prior to screening and FEV1 50- 90 % of predicted normal (pre-bronchodilator) value 3. Patients able to demonstrate at least >=12% and >=200ml improvement in FEV1 from the pre-bronchodilator value within 30 minutes (±10mins) after inhalation of Salbutamol 400μg 4. Patient willing to perform all study related procedures including the use of study inhalers, Spirometry and peak flow meter and willing to complete the patient diary
Exclusion criteria
Exclusion criteria: 1. COPD as defined by the European Respiratory Society (ERS) â?? Consensus Statement 2. Patients with history of more than 10 packs/year of cigarettes and current smokers 3. Patients with a history of hypersensitivity to Formoterol / Budesonide and or any other ingredients 4. History of near fatal asthma and / or admission in intensive care unit because of asthma within past one year. 5. Female subjects who are pregnant, nursing or planning a pregnancy during the study 6. History of alcohol and/or substance abuse within 12 months prior to the Screening Visit 7. Subjects who have participated in another investigational drug or device research study within 30 days of enrolment 8. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean difference between groups in Forced Expiratory Volume in 1 second (FEV1) at the End of Treatment VisitTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Average need for short acting beta 2 agonist (puffs/day/patient) during the study periodTimepoint: 12 weeks;Mean change in day-time & night-time asthma symptoms score from baseline to end of treatment visitTimepoint: 12 weeks;Mean change in PEFR from baseline to End of Treatment VisitTimepoint: 12 weeks;Mean number of days without nocturnal awakening during 12 week of treatment periodTimepoint: 12 weeks;Overall global impression of change as assessed by patient and investigator at the end of treatment visitTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Shailendra Sachan
Glenmark Pharmaceuticals Ltd
Outcome results
None listed