CTRI/2023/01/048668 [Registered on: 02/01/2023] Trial Registered Prospectively
Last Modified On:
08/02/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Efficacy and safety study to assess between three drugs (Inhaler) in patients with Chronic Obstructive Pulmonary Disease
Scientific Title of Study
A Multi-center, Randomized, Open-label, Comparative, Parallel Group study to assess the efficacy and safety of a fixed dose combination of Lupins Glycopyrronium plus Vilanterol plus Fluticasone dry powder inhaler versus fixed dose combination of Glycopyrronium plus Formoterol plus Fluticasone dry powder inhaler in patients with Chronic Obstructive Pulmonary Disease
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
LRP/VGFDPI/2021/004 Version 2.0 dated 10 Jan 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Neelakant Krishnan
Designation
Head Clinical Operations
Affiliation
Lupin Limited
Address
46A/47A, Nande Village, Mulshi Taluka, Pune 412115, Maharashtra, India
Pune MAHARASHTRA 412115 India
Phone
9873715630
Fax
Email
neelakantkrishnan@lupin.com
Details of Contact Person Scientific Query
Name
Dr Hemasundara Rao Dumpala
Designation
Deputy General Manager- Medical Monitoring and Safety Monitoring
Affiliation
JSS Medical Research Asia pacific Private Limited
Address
Tower 2,1st Floor, South Wing, L and T Business, Faridabad, Haryana-121003, India
Faridabad HARYANA 121003 India
Phone
8125991858
Fax
Email
hemasundara.dumpala@jssresearch.com
Details of Contact Person Public Query
Name
Dr Jayashri Krishnan
Designation
Director-Operations
Affiliation
JSS Medical Research Asia pacific Private Limited
Address
Tower 2,1st Floor, South Wing, L and T Business, Faridabad, Haryana-121003, India
Faridabad HARYANA 121003 India
Phone
9771407484
Fax
Email
Jayashri.krishnan@jssresearch.com
Source of Monetary or Material Support
Lupin Limited
46A/47A, Nande Village, Mulshi Taluka,
Pune 412115, Maharashtra, India
Primary Sponsor
Name
Lupin Limited
Address
46A/47A, Nande Village, Mulshi Taluka, Pune 412115, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
JSS Medical Research Asia pacific Private Limited
Tower 2,1st Floor, South Wing, L and T Business,Faridabad,Haryana-121003,India
Room No: 104, 1-5-56/29, Old Alwal Rd, beside Bharat Petroleum, Near IG Statue, Banda Basti, Old Alwal, Alwal, Secunderabad, Telangana 500010, India Medchal TELANGANA
7731030321
upendramd190@gmail.com
Dr Sanjay Verma
G.S.V.M Medical College
Room No: 11, Ground Floor, Department of Respiratory Medicine, Swaroop Nagar,
Kanpur, Uttar Pradesh 208002, India
Kanpur Nagar UTTAR PRADESH
9415075478
drskverma78@rediffmail.com
Dr Shreehas Bardapurkar
Ishwar Institute of Health Care
Ishwar Heights, 1st floor, plot no-7,
gut no 6/1, beside Punjabi bhavan, Padegaon,
Aurangabad-431002, Maharashtra, India
Aurangabad MAHARASHTRA
9405912791
sbardapurkar@gmail.com
Dr Neeraj Gupta
JLN Medical College
Basement, Kala Bagh, Ajmer-305001
Rajasthan, India
Ajmer RAJASTHAN
9829101942
drneerajajmer@yahoo.com
Dr Rajkumar Nikalje
Lifepoint Multispecialty Hospital
Department of Pulmonary Medicine, Ground floor, 145/1, Mumbai-Bangalore Highway, Near Hotel Sayaji, Wakad, Pune-411057, Maharashtra, India
Pune MAHARASHTRA
9730475068
nikaljeraj80@gmail.com
Dr Siddharth Taneja
Maharaja Agrasen Hospital
Room No: 11, Ground Floor.
Dept. of Respiratory Diseases, West Punjabi Bagh, New Delhi-110026, India
West DELHI
9720592309
doc.with.vision@gmail.com
Dr Manish Kumar Jain
Maharaja Agrasen Superspeciality Hospital
Room No-09, Department of Pulmonary
Central Spine, Division-Pulmonology, Agrasen Aspatal Marg Sector 7, Vidyadhar Nagar, Jaipur, Rajasthan – 302039, India.
Jaipur RAJASTHAN
9414414834
Doctormanishjain2@gmail.com
Dr Pawan Kumar Singh
Pt. B. D. Sharma, PGIMS
Room No: 130, 1st Floor.
Department of Pulmonary & Critical Care Medicine, Rohtak, Haryana 124001, India Rohtak HARYANA
8437013094
ga.ps.complete@gmail.com
Dr Monica Gupta
Samvedna Hospital
Ground Floor, Main Building, B27/88G,
New Colony, Ravindrapuri,
Varanasi-221005, India.
Varanasi UTTAR PRADESH
Glycopyrronium 12.5 µg plus Formoterol 12 µg plus Fluticasone 250 µg DPI for Twice a day Inhalation
Treatment Period:12 Weeks
Intervention
Glycopyrronium 50 µg plus Vilanterol 25 µg plus Fluticasone 100 µg dry powder inhaler (DPI)
Glycopyrronium 50 µg plus Vilanterol 25 µg plus Fluticasone 100 µg dry powder inhaler (DPI) for once-a-day inhalation
Treatment Period:12 Weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
Subjects meeting all the following criteria will be participating in the trial:
1. Male or female patients, aged ≥18 to ≤ 75 years at screening
2. Patients with a diagnosis of COPD (as defined by the GOLD Guidelines, 2021)
3. Post-bronchodilator FEV1 ≥30% and <80% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) ratio < 0.70
4. A modified Medical Research Council dyspnoea scale (mMRC) grade 2 or greater
5. History of exacerbations (≥2 moderate or ≥1 severe exacerbation) of COPD within 12 months before screening
6. Subjects on inhaled corticosteroid (ICS) with or without a long-acting β2 agonist (LABA) (as a free or fixed combination), or ICS with a long- acting muscarinic antagonist (LAMA), or LABA with LAMA (as a free or fixed combination), or LAMA monotherapy as maintenance treatment for at least 1 month before screening
7. Current or previous cigarette/beedi smokers with a history of cigarette/beedi smoking of at least 10 pack/years. (Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Screening Visit)
ExclusionCriteria
Details
1. Patients who are currently receiving triple drug treatment with LABA+LAMA+ICS
2. Known respiratory disorders other than COPD including, but not limited to the following: asthma, tuberculosis, alpha-1 antitrypsin deficiency, cystic fibrosis, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
3. Evidence or history of other clinically significant cardiovascular disease or abnormality (such as, but not limited to, congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, arrhythmia, long QT syndrome, atrial fibrillation), renal, neurological, endocrine, immunological, psychiatric, hepatic, or hematological disease or abnormality which, in the opinion of the investigator, are clinically significant and would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates during the study
4. Significant abnormality that suggests chest disease other than COPD, on chest X-ray or computed tomography (CT) scan taken within six months before screening. If there is no chest X-ray/CT scan is taken within six months prior to screening, a chest X-ray will be performed during screening to rule out any other significant abnormality
5. History of paradoxical bronchospasm, uncontrolled narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, or severe renal impairment or urinary retention or any other condition, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic or long-acting beta-agonist agent
6. History of allergy or hypersensitivity to any of the ingredients of study drugs or components of the delivery system
7. Suspected or confirmed SARS-COV2 infection at screening (prior to randomization the subjects will be tested for COVID 19 through rapid antigen test).
8. Hospitalization for COPD exacerbation or pneumonia within three months prior to screening. Any subject who experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded
9. Use of oral/parenteral corticosteroids or antibiotics for COPD exacerbation within six weeks prior to screening
10. Clinically significant abnormal electrocardiogram (ECG) finding at screening
11. Lung volume reduction surgery within 12 months prior to the initiation of the study
12. Requirement of long term (> 12 hours daily) oxygen therapy
13. Unable to stop the following medications at the defined times prior to screening spirometry:
Medication Required washout period prior to screening spirometry
Ipratropium or 8 Hrs
ipratropium/salbutamol
combination product
Inhaled short acting β-agonists 6 hours
Oral β 2-agonists 48 hours
Long acting β-agonists
(salmeterol and formoterol)
or ICS/LABA combination products 48 hours
Xanthines 48 hours
Cromolyn and nedocromil inhalers 24 hours
Zafirlukast, montelukast, zileuton 48 hours
Long-acting anticholinergics
(Tiotropium etc.) 48 hours
Oral or parenteral corticosteroids 6 weeks
Any other investigational medication 30 days or 5 half-lives of the
investigational drug (whichever is longer)
Depot corticosteroids 3 months
Inhaled corticosteroids (ICS) Washout not required
15.Currently enrolled in another interventional clinical study or have used any IPs, study drug, or device within 30 days or 5 times the half-life, whichever was longer preceding informed consent or scheduled to participate in another clinical study involving an IP.
Additional exclusion criteria for Run-In period:
COPD exacerbation requiring treatment with antibiotics, systemic corticosteroids (oral or intravenous), and/or a hospitalization during screening and run-in period
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change from baseline in trough FEV1
12 weeks
Secondary Outcome
Outcome
TimePoints
1. Change from baseline in Trough FEV1
2.Change from baseline in 2 h post-dose FEV1
3.Proportion of patients requiring use of rescue medication over treatment period
4. Proportion of patients with COPD exacerbations during the treatment period
5. Change from baseline in mMRC score
1.week 4 and week 8
2.week 12
3.week 12
4.week 12
5. week 4, week 8 and week 12
Target Sample Size
Total Sample Size="278" Sample Size from India="278" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A Multi-center, Randomized, Open-label, Comparative,
Parallel Group study to assess the efficacy and safety of a fixed dose
combination of Lupin’s Glycopyrronium + Vilanterol + Fluticasone dry powder
inhaler versus fixed dose combination of Glycopyrronium + Formoterol +
Fluticasone dry powder inhaler in patients with Chronic Obstructive Pulmonary
Disease.