A multicentre, open label study to assess product functionality after repeated use of Albuterol Sulfate Inhalation Aerosol with Dose Indicator [Each actuation delivers 100 mcg albuterol (i.e., 108 mcg of albuterol sulfate) equivalent to 90 mcg albuterol from the mouthpiece] [Manufactured By: InvaGen Pharmaceuticals Inc., (a subsidiary of Cipla Ltd.) Fall River-MA02720] in subjects with asthma or COPD.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cipla Ltd.
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- 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.
Overview
Brief Summary
The objective of the study is to assess the product functionality (via in vitro assessments) after repeated use of Albuterol Sulfate Inhalation Aerosol with Dose Indicator manufactured by InvaGen Pharmaceuticals Inc., (a subsidiary of Cipla Ltd.) Fall River -MA02720 in subjects with asthma or COPD.
This study does not have any efficacy, safety or pharmacokinetic endpoints for assessment of Albuterol Sulfate Inhalation Aerosol with Dose Indicator of Cipla Ltd. Adverse events will be monitored throughout the course of the study. In accordance to the US FDA guidance (April 2018), the patient used devices would be retrieved and tested for in vitro assessments.
Albuterol (Salbutamol) is an old product approved in India for use in Asthma and COPD patients (patients with reversible obstructive airway disease) which is the population that will be included in the said study.
The purpose of the referenced study is only to check in-vitro product performance. The purpose of the study is not to investigate clinical efficacy, safety or pharmacokinetics of the drug product. The used devices will be subjected to chemical analysis only and to check device functionality at the analytical laboratory.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female subjects who are 18 – 75 years (both inclusive) of age at the time when informed consent is obtained.
- •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.
- •Subjects on stable treatment for at least 2 weeks prior to screening
- •Patient whose current rescue therapy can be replaced with study therapy as assessed by the investigator.
- •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
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- Safety measures including vital signs and adverse event(Throughout the study)
Investigators
Dr Gaurav Mittal
Cipla Ltd.