Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Albuterol sulfate HFA inhalation aerosol: Dose Strength: E.Q. 90 mcg of albuterol Base/Inhalation
Dosage form: Aerosol, pressurized metered dose inhaler (pMDI)
Route of administration:
Sponsors
Ms Macleods Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and non-pregnant, non-lactating female subjects aged between 18 to 65 years (both ages inclusive) Subjects diagnosed with bronchial asthma by physician at least 6 months prior to screening visit date Currently on stable chronic asthma treatment regimen for at least 2 weeks prior to screening visit date Females of childbearing potential must be willing to consistently use an acceptable method of contraception for the duration of the study Is willing to give their signed written informed consent to participate in the study Is willing to comply with all aspects of the protocol Ability to replace current short acting beta agonists with Albuterol sulfate HFA inhalation aerosol 90 mcg base inhalation of Macleods Pharmaceuticals Ltd for use as two inhalations twice a day for the duration of the study treatment period
Exclusion criteria
Exclusion criteria: A subject will not be eligible to participate in the study if any of the following criteria are fulfilled at screening: 1. History of life-threatening asthma that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s) within the past one year prior to screening visit. 2. History of any asthma related hospitalizations within the past one year prior to enrolment visit 3. Need for daily oral corticosteroids within past three months prior to screening visit 4. Known intolerance or hypersensitivity to any component of the albuterol pressurized metered dose inhaler (pMDI) or history of any adverse reaction to, sympathomimetic drugs (e.g., formoterol, albuterol, salbutamol) or any other constituents of the study treatment 5. Known history of diabetic ketoacidosis, hypokalemia, or fluctuations in potassium levels 6. Evidence or history of clinically significant disease or abnormality including congestive heart failure, coronary insufficiency, cardiac arrhythmias, convulsive disorders, hyperthyroidism, uncontrolled artery disease, cardiac dysrhythmia, or ECG with evidence of ischemic heart disease. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other disease or that, in the opinion of the Investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates in the study 7. Presence of any abnormal clinically significant laboratory investigation at screening visit that, in the opinion of the Investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates in the study 8. History of paradoxical bronchospasm 9. Has participated in another investigational study or device research study within 30 days before screening visit date or five half-lives preceding the screening period (whichever is longer) 10. Females who are pregnant, breast-feeding, or planning pregnancy during study 11. Subjects unable to follow training of inhalation technique as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the Albuterol sulfate HFA inhalation aerosol (E.Q. 90 mcg base / inhalation) pMDI (of Macleods Pharmaceuticals Ltd.) used by subjects with bronchial asthma as study treatment will be collected and sent to analytical laboratory (Oxalis Labs. India.) to assess the product functionality (pharmaceutical performance) as assessed by in-vitro parameters (e.g. DDU, APSD) and dose-counter functionality as pre-defined in chemistry manufacturing and control (CMC) protocol prepared separately. Any devices if malfunctioned will be also collected and sent to Oxalis Labs. India. for further investigation.Timepoint: Day 1 of study treatment, From Treatment Day 6 to Treatment Day 20 From Treatment Day 21 to Treatment Day 31 End of treatment (EOT) visit / Investigational product (IP) collection visit / Treatment Day 36 to Treatment Day 46 ( 4 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety AssessmentTimepoint: End of treatment visit | — |
Countries
India
Contacts
Public ContactPriyanka Shrivastava
Macleods Pharmaceuticals Ltd
Outcome results
None listed