Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: Salbutamol Pressurised Inhalation (100 mcg per actuation) CFC Free pMDI: One puff as a single dose
Intervention2: Salbutamol Pressurised Inhalation (100 mcg per actuation) CFC Free pMDI
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male or female outpatients aged >=18 years to 2) Clinical diagnosis of asthma for at least 6 months and FEV1 >=60 to 3) Patients able to demonstrate at least >=12% and >=200ml improvement in FEV1 from the pre-bronchodilator value after inhalation of Salbutamol 200mcg 4) Patient willing to give written informed consent and willing to perform all study related procedures including the use of study inhalers and spirometry
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 including cigars, pipe, chewing tobacco, and snuff 3) Patients with a history of hypersensitivity to salbutamol and or any other ingredients of study medication or any immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug 4) Life-Threatening Asthma: A patient must not have life-threatening asthma 5) Patients with only intermittent or seasonal or exercise-induced asthma are excluded from participation in this study 6) Female subjects who are pregnant, nursing or planning a pregnancy during the study 7) History of alcohol and/or substance abuse within 12 months prior to the screening visit 8) Patients who have participated in another investigational drug or device research study within 30 days prior to enrolment 9) Patients who are using any medication or has any disease or clinically significant laboratory abnormality which in the judgment of the investigator will interfere with the conduct or interpretation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Equivalence of change from baseline FEV1 AUC0-6hrs between 100 mcg of Salbutamol Pressurised Inhalation (100 mcg per actuation) CFC Free and Aerolin® Spray (Salbutamol 100 mcg per actuation) and 200 mcg of Salbutamol Pressurised Inhalation (2 puffs x100 mcg per actuation) CFC Free and Aerolin® Spray (Salbutamol 2 puffs x 100 mcg per actuation)Timepoint: 6 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 pharmacodynamic parameters (â??FEV1max, time to maximum observed effect [Tmax], area under the change from baseline effect-time curve [AUC], AUC%, and duration of effect)Timepoint: 6 hours;FEV1max (maximum FEV1 value occurring post treatment) and FEV1max % (maximum forced expiratory volume expressed as a percentage of baseline)Timepoint: 6 hours;The mean difference between groups in area under curve of the effect on one hour measured FVC between baseline and 6 hours (AUC0-6hrs)Timepoint: 6 hours;The mean difference between two doses (100 mcg and 200 mcg) within the groups in area under curve of the effect on one hour measured FEV1 and FVC between baseline and 6 hours (AUC0-6hrs)Timepoint: 6 hours | — |
Countries
India
Contacts
Public ContactDr Shailendra Sachan
Glenmark Pharmaceuticals Ltd
Outcome results
None listed