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CTRI Number  CTRI/2024/01/061998 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   An open label, single treatment, repeated dose study of Albuterol sulfate inhalation aerosol in subject with Asthma or COPD. 
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gaurav Mittal 
Designation  Medical and Safety Expert 
Affiliation  Cipla Ltd. 
Address  Cipla Ltd. LBS Marg, Chandan Nagar, Vikhroli West, Mumbai, India

Mumbai
MAHARASHTRA
400083
India 
Phone  9927971349  
Fax    
Email  Gaurav.Mittal2@Cipla.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gaurav Mittal 
Designation  Medical and Safety Expert 
Affiliation  Cipla Ltd. 
Address  Cipla Ltd. LBS Marg, Chandan Nagar, Vikhroli West, Mumbai, India

Mumbai
MAHARASHTRA
400083
India 
Phone  9927971349  
Fax    
Email  Gaurav.Mittal2@Cipla.com  
 
Details of Contact Person
Public Query  
Name  Dr Gaurav Mittal 
Designation  Medical and Safety Expert 
Affiliation  Cipla Ltd. 
Address  Cipla Ltd. LBS Marg, Chandan Nagar, Vikhroli West, Mumbai, India

Mumbai
MAHARASHTRA
400083
India 
Phone  9927971349  
Fax    
Email  Gaurav.Mittal2@Cipla.com  
 
Source of Monetary or Material Support  
Cipla Ltd., R & D Centre, North Block, 4th floor, LBS Marg, Vikhroli (West), Mumbai 400083 
 
Primary Sponsor  
Name  Cipla Ltd. 
Address  LBS Marg, Chandan Nagar, Vikhroli West, Mumbai, Maharashtra - 400083 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sahebrao Kondiba Toke  Ojas Multispeciality Hospital  Ground floor, Clinical Research Department, Sr. no 203-1, D. Y. Patil College Road, Ravet, Pune 412101, Maharashtra, India.
Pune
MAHARASHTRA 		 9503553685

dr.sahebrao@gmail.com 
Dr Pankaj Magar  Pulse Multispeciality Hospital  OPD No-1,1st floor, Sr.No.51/7/B/1, Vishwa Arcade Opp. Deccan Pavilion Hotel, Mumbai Bangalore Highway, Narhe Pune-411041, Maharashtra, India
Pune
MAHARASHTRA 		 8668656112

drpankajmagar.pulse@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee of Pulse Multispecialty Hospital  Approved 
Ojas Multispeciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J459||Other and unspecified asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 albuterol sulfate) equivalent to 90 mcg albuterol from the mouthpiece] twice a day. Duration of study for individual subject will be up to 40 days.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.  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 Outcome  
Outcome  TimePoints 
Safety measures including vital signs and adverse event  Throughout the study 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 05/02/2024 
Date of Study Completion (India) 06/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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