Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Albuterol Sulfate bInhalation Aerosol 90 mcg (with dose indicator) manufactured by Cipla Ltd. (India): Two puffs (90 mcg/actuation of albuterol base X two inhalations) twice a day (once
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects who are >= 18 years of age at the time when informed consent is obtained. 2. Subjects diagnosed with asthma or COPD by the investigator in accordance to relevant guidelines i.e. GINA guidelines for Asthma diagnosis and management and GOLD guidelines for COPD diagnosis and management 3. Subjects on treatment of Asthma or COPD requiring albuterol. 4. Women of child bearing potential (WOCBP) must commit to be consistent and for correct use of an acceptable method of birth control (acceptable method will be at the investigatorâ??s discretion) throughout the study 5. Subjects who are able to use pMDI effectively as per the standardized inhalation technique
Exclusion criteria
Exclusion criteria: 1. History of life-threatening asthma/COPD that required intubation and/or was associated with hypercapnoea, respiratory arrest, or hypoxic seizures, asthma/COPD related syncopal episode(s) within the past one year prior to enrolment visit. 2. History of any asthma or COPD-related hospitalizations within the past one year prior to enrolment visit. 3. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension (systolic BP >=160 mm Hg or diastolic BP >100 mm Hg), uncontrolled coronary artery disease, myocardial infarction, Stroke within 3 months prior to the enrolment visit, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study 4. Intercurrent disease or condition that, in the opinion of the Investigator, might compromise the subjectâ??s continued safety or eligibility for the study 5. History of any adverse reaction; known hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any inhaled, or therapy or any other constituents of the investigational product 6. Factors (e.g., infirmity, disability, geographic location) that the investigator felt would likely limit the subjectsâ?? compliance with the study protocol or scheduled clinic visits 7. Women of childbearing potential (WOCBP) who are lactating or pregnant atenrolment visit, as documented by a positive screening pregnancy test (see schedule of study events). For this study, WOCBP is defined as females following menarche until becoming postmenopausal or undergoing permanent sterilization. Postmenopausal is defined as no menses for 12 months without an alternative medical cause. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy 8. Study participation by clinical investigator site employees and/or their immediate relatives 9. Subjects unable to use pMDI device with or without spacer or comply with the study regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study has the following primary objective: â?¢ To assess the device functionality (via pharmaceutical performance) after repeated use of Albuterol Sulfate Inhalation Aerosol 90 mcg (with dose indicator) manufactured by Cipla Ltd. (India) by asthma and COPD subjects.Timepoint: visit 4 day 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Albuterol Sulfate Inhalation Aerosol 90 mcg (with dose indicator) manufactured by Cipla Ltd. (India).Timepoint: visit 4 day 40 | — |
Countries
India
Contacts
Public ContactDrBill Brashier
Cipla-Ltd Director-Global Respiratory CRD
Outcome results
None listed