To study the pharmacodynamic effect of Ipratropium Bromide 21 mcg Hydrofluoroalkane (HFA) in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Completed

• Conditions: Chronic obstructive pulmonary disease, unspecified,

• Registration Number: CTRI/2022/02/040421
• Lead Sponsor: Sun Pharmaceutical Industries Ltd SPIL

Brief Summary

·        The purpose/objective  of the study is todemonstrate the Pharmacodynamic equivalence of the Test formulation ofIpratropium 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 associatedpublications for the test product. The reference product, Atrovent, is anapproved and marketed product. The USFDA assessment can be accessed using thebelow link

<https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process>

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-05
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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€

Trial Locations

Locations (18)

Apollo Spectra Hospital Pvt. Ltd.; 🇮🇳 Nagar, UTTAR PRADESH, India

Criticare hospital & Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

Dr. Hedgewar Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Gleneagles Global Hospital; 🇮🇳 Hyderabad, TELANGANA, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Hindusthan Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Ishwar Institute of Health Care; 🇮🇳 Aurangabad, MAHARASHTRA, India

JSS Hospital; 🇮🇳 Mysore, KARNATAKA, India

Kamineni Hospitals Private Limited; 🇮🇳 Hyderabad, TELANGANA, India

Lata Mangeshkar Hospital & Research Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

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Apollo Spectra Hospital Pvt. Ltd.

🇮🇳Nagar, UTTAR PRADESH, India

Dr Sandeep Katiyar

Principal investigator

9889888080

skkatiyarin@gmail.com