CTRI/2019/01/017005 [Registered on: 09/01/2019] Trial Registered Prospectively
Last Modified On:
08/01/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Other (Specify) [Device functionality study]
Study Design
Other
Public Title of Study
In:vitro assessment of device/inhaler after repeated patient use
Scientific Title of Study
A multicentre, open label study to assess device functionality by in-vitro performance after repeated use of Albuterol Sulfate Inhalation Aerosol 90 mcg (with dose indicator) manufactured by Cipla Ltd. (India) in asthma and chronic obstructive pulmonary disease (COPD) subjects.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
DrBill Brashier
Designation
Director-Global Respiratory CRD
Affiliation
Cipla Ltd -Director-Global Respiratory CRD
Address
CIPLA Ltd.R & D Centre, North Block, L.B.S. Road, Vikhroli (W), Mumbai-400 083, India.
Mumbai MAHARASHTRA 400083 India
Phone
02225756451
Fax
Email
bill.brashier@cipla.com
Details of Contact Person Scientific Query
Name
DrBill Brashier
Designation
Director-Global Respiratory CRD
Affiliation
Cipla-Ltd Director-Global Respiratory CRD
Address
CIPLA Ltd.R & D Centre, North Block, L.B.S. Road, Vikhroli (W), Mumbai-400 083, India.
Mumbai MAHARASHTRA 400083 India
Phone
02225756451
Fax
Email
bill.brashier@cipla.com
Details of Contact Person Public Query
Name
DrBill Brashier
Designation
Director-Global Respiratory CRD
Affiliation
Cipla Ltd.-Director-Global Respiratory CRD
Address
CIPLA Ltd.R & D Centre, North Block, L.B.S. Road, Vikhroli (W), Mumbai-400 083, India.
Mumbai MAHARASHTRA 400083 India
Phone
02225756451
Fax
Email
bill.brashier@cipla.com
Source of Monetary or Material Support
3rd Floor, Department of Clinical Research, Lifepoint Hospital, 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune- 411 057
AMAI Charitable Trusts ACE Hospital and Research Centre, 32/2A, Erandwane, Pune- 411004.
Ashirwad Hospital & Research Centre, Maratha Section, Near Jijamata Udyan, Maratha Section, Ulhasnagar 421004.
Chest Research Foundation, Survey No: 15 Marigold Premises, Kalyani Nagar, Pune- 411014, Maharashtra, India
Krishna Institute of Medical Sciences Deemed University Karad, Pune-Banglore Highway-4, Malakapur Road, Karad. Maharashtra, INDIA
Maharashtra Medical Foundation Joshi Hospital, 778, Shivaji nagar, oppposite kamla Nehru Park, Pune411004, Maharashtra, India.
Modi Clinic Chest and ENT, 61A, Raksha Lekha Society, Pune - Satara Road, Dhankawadi, Pune, Maharashtra 411043
Primary Sponsor
Name
Cipla Ltd
Address
R & D Centre, North Block, L.B.S. Road, Vikhroli (W), Mumbai-400 083, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 7
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
DrHimanshu Pophale
ACE Hospital and Research Centre
AMAI Charitable Trusts ACE Hospital and Research Centre, Roon No, 32/2A,Deparment Clinical Research, Division, Clinical Research Respiratory Erandwane, Pune- 411004. Pune MAHARASHTRA
9503939461
himanshupophale@yahoo.co.in
DrShrikant Deshpande
Ashirwad Hospital & Research Centre
Ashirwad Hospital & Research Centre, Maratha Section, Near, Department: Clinical Reseach, Division: Clinical Research Respiratory, Room no: Dr.Deshpandes cabin. Jijamata Udyan, Maratha Section, Ulhasnagar 421004. Thane MAHARASHTRA
9822017445
writetoshrikant@rediffmail.com
DrSudeep Salvi
Chest Research Foundation
Department: Research, Division: Chest reaseach Foundation Survey No: 15 Marigold Premises, Kalyani Nagar, Pune- 411014, Maharashtra, India. Pune MAHARASHTRA
9823018373
ssalvi@crfindia.com
Dr Shilpa Patil
Krishna Institute of Medical Sciences Deemed University
Department: Clinical Research, Division: Respiratory,Krishna Institute of Medical Sciences Deemed University Karad, Pune-Banglore Highway-4, Malakapur Road, Karad. Maharashtra, INDIA Kolhapur MAHARASHTRA
9823988297
drshilpa.kims@gmail.com
Dr Rajkumar Nikalje
Lifepoint Hospital
3rd Floor, Department: Clinical Research, Lifepoint Hospital, Room No: 145/1,Division: Respiratory clinical research, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune- 411 05 Pune MAHARASHTRA
9730475068
nikalijero80@gmail.com
Dr Vijay Warad
Maharashtra Medical Foundation Joshi Hospital
Maharashtra Medical Foundation Joshi Hospital, Room No.778,Department: Clinical Research, Division: Clinical Research, Shivaji nagar, oppposite kamla Nehru Park, Pune411004, Maharashtra, India. Pune MAHARASHTRA
9822436184
vijaypwarad@gmail.com
DrMahavir Modi
Modi Clinic Chest and ENT
Modi Clinic Chest and ENT, Room no:61A,Department: Clinical Research, Division: Clinical Research Respiratory Raksha Lekha Society, Pune - Satara Road, Dhankawadi, Pune, Maharashtra 411043 Pune MAHARASHTRA
9822253596
drmmodi@yahoo.co.in
Details of Ethics Committee
No of Ethics Committees= 7
Name of Committee
Approval Status
Ashirwad Ethics Committee Ashirwad Hospital & Research Centr
Submittted/Under Review
Ethics Commitee,Rao Nursing Home
Submittted/Under Review
Institutional Ethics Commitee of Chest Research Foundation
Submittted/Under Review
Institutional ethics committee of Krishna institute of medical sciences deemed to be university
Submittted/Under Review
Institutional Ethics Committee, ACE Hospital & Research Center
Submittted/Under Review
lifepoint Research
Approved
Maharashtra Medical Research SocietyMaharashtra Medical Research Society
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Notified
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 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 in the morning and once in the evening) + s.o.s. (not to exceed 12 puffs within 24 hrs in total including study dose taken per day) for up to 40 days.
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
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 investigator’s discretion) throughout the study 5. Subjects who are able to use pMDI effectively as per the standardized inhalation technique
ExclusionCriteria
Details
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 subject’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 subjects’ 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.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
This study has the following primary objective: • 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.
visit 4 day 40
Secondary Outcome
Outcome
TimePoints
To assess the safety and tolerability of Albuterol Sulfate Inhalation Aerosol 90 mcg (with dose indicator) manufactured by Cipla Ltd. (India).
visit 4 day 40
Target Sample Size
Total Sample Size="75" Sample Size from India="75" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
09/01/2019
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="8" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
None
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a device performance study, to assess the in:vitro performance of the device after the patient uses the device repeatedly over the period of time. there are no safety or efficacy assessments performed in the study. The used devices by the patients will be collected back and send to central testing laboratory for in vitro analysis. key parameters such as delivered dose uniformity and Aerodynamic Particle Sized Diameter will be determined. This data will help to assess whether there is any impact on the device performance after repeated use by patients in clinical setting.