Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Albuterol Sulfate Inhalation Aerosol: Dosing regimen: Two puffs of Albuterol Sulfate Inhalation Aerosol with Dose Indicator [Each actuation delivers 100 mcg albuterol (i.e., 108 mcg of
Sponsors
Cipla Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects who are 18 – 75 years (both inclusive) of age at the time when informed consent is obtained. 2. Subjects diagnosed with asthma or COPD by the investigator in accordance with relevant guidelines i.e., GINA guidelines 2023 for asthma diagnosis and GOLD guidelines 2023 for COPD. 3. Subjects on stable treatment for at least 2 weeks prior to screening 4. Patient whose current rescue therapy can be replaced with study therapy as assessed by the investigator. 5. Women of childbearing potential (WOCBP) must commit to be consistent and for correct use of an acceptable method of birth control (acceptable method will be at the investigator’s discretion) throughout the study.
Exclusion criteria
Exclusion criteria: 1.History of life threatening asthma or COPD that required intubation and or was associated with hypercapnoea respiratory arrest or hypoxic seizures asthma or COPD related syncopal episodes 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 4.Intercurrent disease or condition that, in the opinion of the Investigator, might compromise the subject’s continued safety or eligibility for the study 5.Factors (e.g., infirmity, disability, geographic location) that the investigator felt would likely limit the subjects’ compliance with the study protocol or scheduled clinic visits 6.Women of childbearing potential (WOCBP) who are lactating or pregnant at enrolment visit, as documented by a positive screening pregnancy test. 7.Subjects unable to use pMDI correctly after adequate training of inhalation technique and device use as deemed acceptable by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Used devices will be sent to the analytical laboratory to measure relevant product in vitro characteristics including dose counter functionality test. Number of used devices will be descriptively summarized and device characteristics data received from external labs will be presented as frequencies and percentage wise. If there are any malfunctioning devices, this will also be summarized by frequency and percentages.Timepoint: There are four different timepoints for collection of information regarding device malfunctioning at enrolment visit (Day 1), Day 10 (Telephone Follow up), Day 20 (Interim Visit), Day 30 (Telephone Follow up) and Day 40 (EOS visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety measures including vital signs and adverse eventTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Gaurav Mittal
Cipla Ltd.
Outcome results
None listed