CTRI/2022/02/040421 [Registered on: 18/02/2022] Trial Registered Prospectively
Last Modified On:
16/10/2023
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
To study the pharmacodynamic effect of Ipratropium Bromide 21 mcg Hydrofluoroalkane (HFA) in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Scientific Title of Study
Pharmacodynamic Bioequivalence of two formulations of Ipratropium Bromide (21 mcg) HFA in Subjects with Chronic Obstructive Pulmonary Disease: A Randomized, Observer-Blind, Three Treatment, Three Period, Six Sequence, Single Dose, Crossover, Placebo and Active Controlled Comparative Study
14/138, Mall Rd, near B.N.S.D Inter College, Chunniganj Chauraha, Chunni Ganj, Permat, Kanpur, Uttar Pradesh 208001
Kanpur Nagar UTTAR PRADESH
9889888080
skkatiyarin@gmail.com
Dr Vivek Gupta
Criticare hospital & Research Institute
Criticare hospital & Research Institute, 4th Floor Dhanshree Complex, Near Hotel Hardeo, Sitabuldi, Nagpur, Maharashatra, India 440012.
Nagpur MAHARASHTRA
9373115548
vivekurvashi@yahoo.co.in
Dr Venkatesh Deshpande
Dr. Hedgewar Hospital
Gajanan Mandir Road, Garkheda, Aurangabad-431005, Maharshtra, India
Aurangabad MAHARASHTRA
9881763635
venkypande72@gmail.com
Dr Tapaswi Krishna Patibandla
Gleneagles Global Hospital
6-1-1070/ 1 to 4, Ladikapul, Hyderabad- 500004, Telengana, India
Hyderabad TELANGANA
9490935455
tapaswikrishna84@gmail.com
Dr Sanjay Verma
GSVM Medical College
Department of Respiratory Medicine,
GSVM Medical College, Swaroop Nagar, Kanpur- 208002
Kanpur Nagar UTTAR PRADESH
9415075458
drskverma78@rediffmail.com
Dr Srikanth Krishnamurthy
Hindusthan Hospital
523/3 Nava India Road, Udaiyampalayam, Coimbatore-641028, India Coimbatore TAMIL NADU
9894257706
drsrikanthcbe@gmail.com
Dr Bardapurkar Shreehas Suhas
Ishwar Institute of Health Care
Ishwar Institute of Health Care, Ishwar Heights, 1st floor, plot no 7, gut no 6/1, Beside Punjabi bhavan, Padegaon, Aurangabad-431002 Aurangabad MAHARASHTRA
9822314268
ishwarhealthcare@gmail.com
Dr Jayaraju B S
JSS Hospital
Site name JSS HOSPITAL,
Department Respiratory Medicine,
Division NA,
Room no 1090-1096,
Department of TB & Respiratory Medicine, Mahathma Gandhi Road, 570004, India Mysore KARNATAKA
9945671286
drjayarajbs@yahoo.com
Dr Ravindra Reddy Etikala
Kamineni Hospitals Private Limited
Site name Kamineni Hospitals Private Limited
Department Department of Pulmonology,
Division Respiratory Medicine,
Room no OPD No. 2,
L. B. Nagar, 500068, India
Hyderabad TELANGANA
9848023703
rvndrreddy@yahoo.com
Dr Ashish Tulshiram Nikhare
Lata Mangeshkar Hospital & Research Centre
Site name Lata Mangeshkar Multispeciality Hospital, Sitabuldi, Nagpur,
Department Research Department,
Division Pulmonology,
Room no 2,
YMCA Complex, Maharajbagh Road, Sitabuldi, 440012, India Nagpur MAHARASHTRA
91-8149927258
ashoonikh@gmail.com
Dr Nikalje Rajkumar Gautam
Lifepoint Multispeciality Hospital
Site name: Lifepoint Multispecialty hospital
Department: 3rd Floor, Clinical Research Department
Division: -
Room no: 1
145/1, Mumbai-Bangalore Highway, Near Hotel Sayaji, Wakad, 411057, India Pune MAHARASHTRA
9028560535
nikaljeraj80@gmail.com
Dr Sahebrao Toke
OjasMultispeciality Hospital
Site name: Ojas Multispecialty Hospital,
Department: Clinical Research Department,
Division:----,
Room no Ground Floor, Beside Pathological Department
D. Y. Patil Road, Ravet, 412101
Pune MAHARASHTRA
9503553685
dr.sahebrao@gmail.com
Dr Ashish Goyal
Orchid Speciality Hospital
"Sr.No. 2823/3/3, L-square,
Orchid Speciality Hospital,
Panwal Road, Near Dhanari Takat Naka Lohgoan, Pune-411047, Maharashtra, India"
Pune MAHARASHTRA
Route: oral inhalation
Dosage: Two inhalations of study medication
frequency and duration of therapy: one day treatment
Comparator Agent
Reference: Boehringer Ingelheim’s Atrovent® HFA; USA
Route: oral inhalation
Dosage: Two inhalations of study medication
frequency and duration of therapy: one day treatment
Intervention
Test: SPIL’s Ipratropium bromide HFA; India
Route: oral inhalation
Dosage: Two inhalations of study medication
frequency and duration of therapy: one day treatment
Inclusion Criteria
Age From
40.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Men or non-pregnant and non-lactating women aged greater than or equal to 40 years. 2.Diagnosis of COPD as defined by American Thoracic Society (ATS)-Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2021 (patient with dyspnea, chronic cough or sputum production, and/or history of exposure to risk factors for the disease). 3.Post-bronchodilator FEV1 less than or equal to 65% of predicted [criterion evaluated 24 to 72 hours prior to dosing in Period 1].
4.Post-bronchodilator FEV1/FVC ratio less than or equal to 0.70 [criterion evaluated 24 to 72 hours prior to dosing in Period 1]. 5.Able to successfully complete placebo run-in after withholding restricted medications and able to withhold restricted medications for specified duration prior to dosing.
6.Current or former smoker with smoking history of greater than or equal to 10 pack-years.
7.Able to satisfactorily administer the medication and perform pulmonary function test.
8.Willing and able to give written informed consent.9.Subjects of childbearing potential must practice an acceptable method of birth control as judged by the Investigator.
ExclusionCriteria
Details
1.Subjects with evidence or history of significant disease or abnormality other than COPD (such as congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infraction, stroke, glaucoma, or cardiac dysrhythmia). A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study, or a disease which may influence the results of the study, or the subject’s ability to participate in the study.
2.Known respiratory disorder other than COPD, including but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, active bronchiectasis, significant asthma, sarcoidosis, lung fibrosis, pulmonary hypertension, or interstitial lung disease.
3.History of allergy or hypersensitivity to anticholinergic/ muscarinic receptor antagonist agent, beta-2 agonists, or specific intolerance to aerosolized ipratropium bromide-containing products, or known hypersensitivity to any of the non-medicinal ingredients [citric acid, ethanol, propellant HFA 134a (1,1,1,2-tetrafluorethane), nitrogen].
4.History of asthma, allergic rhinitis, or atopy, a blood eosinophil count >6%.
5.Known active tuberculosis based on chest X-ray, physical examination and medical judgment of the investigator.
6.History of having undergone thoracotomy with pulmonary resection. Subjects with a history or a thoracotomy for other reasons will be evaluated per exclusion criterion No. 1.
8.History of narrow angle glaucoma, prostatic hypertrophy, or bladder neck obstruction, which, in the investigator’s opinion, would contraindicate the use of an anticholinergic agent.
9.Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 6 weeks prior to initiation of the study (screening visit).
10.Abnormal and significant electrocardiogram (ECG) finding prior to screening, during the run-in and treatment periods.
11.Treatment for COPD exacerbation within 12 weeks prior to initiation of the study (screening visit).
12.Hospitalization for COPD or pneumonia within 12 weeks prior to initiation of the study (screening visit).
13.Inability to discontinue COPD medications during the run-in and treatment periods.
14.Lung volume reduction surgery within 12 months prior to initiation of the study (screening visit).
15.Chronic oxygen use for >12 hours/ day
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Area under the serial FEV1-time curve calculated from time zero to 6 hours (AUC0-6h) following the treatment
Serial spirometry (FEV1) will be measured at 0, 10, 15, 30, 60, 90, and 120 minutes, and 3, 4, 5, and 6 hours post-dose.
Secondary Outcome
Outcome
TimePoints
Time to peak bronchodilator response (Tmax); FEV1 values at all measurement times within each period
Tmax or time to peak bronchodilator response will be assessed post dosing in each period. The time points for FEV1 measurement will serve as time points for “time measurementâ€
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
·The purpose/objective of the study is to
demonstrate the Pharmacodynamic equivalence of the Test formulation of
Ipratropium Bromide 21 mcg Hydrofluoroalkane (HFA) of SPIL, India and Atrovent®
21 mcg HFA of Boehringer Ingelheim Pharmaceuticals, Inc. in Subjects with COPD.
We will share the findings once the study is complete. There are no associated
publications for the test product. The reference product, Atrovent, is an
approved and marketed product. The USFDA assessment can be accessed using the
below link