| CTRI Number |
CTRI/2021/12/038978 [Registered on: 28/12/2021] Trial Registered Prospectively |
| Last Modified On: |
27/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Glycopyrronium bromide plus Indacaterol |
|
Scientific Title of Study
|
An International, Open, Randomized, Comparative study of the efficacy and safety of the medicinal products Glycopyrronium bromide plus Indacaterol 50 plus 110 μg inhalation powder capsules (PSK Pharma LLC, Russia) and Ultibro Breezhaler 50 plus 110μg inhalation powder capsules(Novartis Pharma AG, Switzerland) in subjects with COPD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GLIND-3/20 Version: 1.0 Date: 30.03.2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Plot No- 10 B , Sector 07, Station Rd, Kamothe, Panvel
Raigarh
MAHARASHTRA
410206
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
dr.sayalitarte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Plot No- 10 B , Sector 07, Station Rd, Kamothe, Panvel
MAHARASHTRA
410206
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
dr.sayalitarte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Plot No- 10 B , Sector 07, Station Rd, Kamothe, Panvel
MAHARASHTRA
410206
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
dr.sayalitarte@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSK Pharma LLC 2 Programmistov 4, premise 215, Dubna town, Moscow Region
141983 |
|
|
Primary Sponsor
|
| Name |
PSK Pharma LLC |
| Address |
2 Programmistov 4, premise 215, Dubna town, Moscow Region
141983 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mudra Clincare |
Plot No- 10 B , Sector 07, Station Rd, Kamothe, Panvel, Maharashtra 410206 |
|
|
Countries of Recruitment
|
India
Russian Federation |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Jain |
Medisecure Superspeciality Hospital |
Department of General
Medicine, First Floor,
Plot No- 10 B , Sector
07, Kamothe.
Raigarh
MAHARASHTRA |
7738664583
mudraclincare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committe, Shree Ashirwad Hospital, Dombivli, ,Maharshtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glycopyrronium bromide plus Indacaterol |
Inhalation Powder Capsules
Dose 1 capsule (50 plus 110 μg) Frequency inhalation 110 time per day for 84 days |
| Comparator Agent |
Tradename Ultibro® Breezhaler®
Generic name Glycopyrronium bromide plus Indacaterol |
Inhalation Powder Capsules
Dose 1 capsule (50 plus 110 μg) Frequency inhalation 110 time per day for 84 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. A diagnosis of moderate-grade COPD, established according to the GOLD guidelines, 2019, at least 12 months before the screening visit
2. The absence of exacerbation of COPD, associated with a change in therapy within 4 weeks prior to the screening visit.
3. The ability to correctly perform the inhalation procedure with the investigational medicinal products.
4. The increase in FEV1 is <12% of the due and <200 ml relative to the initial level 30 minutes after administration of 400 μg of salbutamol.
5. Smoking subjects or those who smoked in the past more than 10 pack/years
6. The absence of exacerbation of COPD, associated with a change in therapy within 4 weeks prior to the screening visit.
7. Body Mass Index (BMI) <35 kg/m2 at the time of the screening visit.
|
|
| ExclusionCriteria |
| Details |
1. Subjects requiring initial treatment for COPD.
2. Hypersensitivity to Glycopyrronium bromide, Indacaterol or any of the components of the medicinal product.
3. Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
4. Demand for excessive use of SABAs
5. Subjects get treated therapy with β-adrenergic blockers for 1 week before the screening visit and in need of their use.
6. Conditions requiring the use of systemic glucocorticosteroids (GCS).
7. The demand for long-term (daily at least 12 hours a day) oxygen therapy for chronic hypoxia.
8. Administration of oral or parenteral GCS in the previous 2 months before the screening visit (3 months for parenteral GCS of the extended release).
9. Glaucoma.
10. Bronchial asthma.
11. Allergic rhinitis, atopic eczema or dermatitis in the acute stage.
12. Respiratory infection and/or moderate or severe exacerbation of COPD and/or exacerbation of COPD, associated with antibiotic therapy, occurring at the time of the screening visit.
13. Pulmonary tuberculosis (active or inactive form).
14. Cystic fibrosis, bronchiectasis, pneumoconiosis, or other history of lung ventilation limitations.
15. Found deficiency of α1-antitrypsin.
16. A history of lung resection or lung transplantation.
17. Class III-IV chronic heart failure according to the classification of the New York Heart Association (NYHA); uncontrollable hypertension; unstable angina, unstable or first diagnosed arrhythmia; tachy-arrhythmia; ischaemic heart disease; myocarditis; aortic stenosis.
18. Myocardial infarction, stroke, or thromboembolism for 6 months before inclusion in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FEV1 variation |
at Visit 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dynamics of FEV1 indicator |
Visits 2, 3 and 4 |
| Dynamics of the absolute PEF indicator |
for Visits 2, 3 and 4. |
| Dynamics of the total CAT score |
for Visits 2, 3, and 4. |
| Dynamics of quality of life (QOL) indicators according to the questionnaire SGRQ |
Visits 2, 3, and 4. |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="250"
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)
|
31/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/12/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by airflow restriction with the development of not completely reversible bronchial obstruction. Airflow restriction is progressing and is associated with an enhanced pathological inflammatory response of the respiratory tract to damaging particles or gases [1, 2]. Drug therapy for COPD is used to prevent and control the symptoms of the disease, improve the subjects life quality, reduce the frequency and severity of exacerbations, and reduce the frequency of deaths [3, 4]. Bronchodilator therapy is the basis for the treatment of Chronic Obstructive Pulmonary Disease (COPD). According to the GOLD recommendations, long-acting bronchodilators are indicated as the basic therapy for COPD, starting from stage II. There are two classes of inhaled medicinal products with a bronchodilator effect: 1) β2 agonists; 2) M-anticholinergics. Indacaterol ‒ the first representative of β2-adrenergic agonists with a rapid, after 5 minutes, onset of action and a long, within 24 hours, action, registered in Russia in early 2011 (the medicinal product was first registered in Europe on November 30, 2009). The rapid onset of action and the duration of the bronchodilation effect of the medicinal product are associated with the affinity of the molecule for the lipid structures of the cell, near which β2-receptors (so-called lipid rafts) are located. In accordance with this concept, the receptors and effectors are combined into one signal platform, which ensures the efficiency and selectivity of signal transmission [5]. Glycopyrronium is an anticholinergic medicinal product with a potent, rapidly onset bronchodilatory effect for the treatment of chronic obstructive pulmonary disease (COPD). Glycopyrronium is available in powder form capsules for inhalation. Numerous studies have shown good tolerability of the medicinal product, including high cardiac safety with long-term use.
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