| CTRI Number |
CTRI/2021/11/038151 [Registered on: 22/11/2021] Trial Registered Prospectively |
| Last Modified On: |
19/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Glycopyrronium bromide 50 μg inhalation powder capsules |
|
Scientific Title of Study
|
An international, open, randomized, comparative study of the efficacy and safety of the medicinal products Glycopyrronium bromide 50 μg inhalation powder capsules (PSK Pharma LLC, Russia) and Seebri® Breezhaler® 50 μg inhalation powder capsules (Novartis Pharma AG , Switzerland) in subjects with COPD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
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, opp. SBI
Bank, 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 |
Trade name: Glycopyrronium bromide
International Nonproprietary Name: Glycopyrronium bromide
|
Pharmaceutical form: inhalation powder capsules
Pharmacotherapeutic group: m-anticholinergic.
Dose: 50 μg Inhalation powder capsules.
Route of Administration- Inhalation
Duration of Intervention- 84 days |
| Comparator Agent |
Tradename: Seebri® Breezhaler®
International Nonproprietary Name: Glycopyrronium bromide
|
Pharmaceutical form: inhalation powder capsules
Pharmacotherapeutic group: m-anticholinergic. Dose: 50 μg Inhalation powder capsules. Route of Administration- Inhalation Duration of Intervention- 84 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 The presence of a signed Informed Consent Form of subject Information Sheet (PIS) for participation in a clinical study.
2 A diagnosis of moderate-grade COPD, established according to the GOLD guidelines, 2019, at least 12 months before the screening visit.
3 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.
4 Smoking subjects or those who smoked in the past more than 10 pack/years
5 The absence of exacerbation of COPD, associated with a change in therapy within 4 weeks prior to the screening visit.
6 The ability to correctly perform the inhalation procedure with the investigational medicinal products.
7 Body Mass Index (BMI) <35 kg/m2 at the time of the screening visit.
8 Consent of the subject to the use of reliable methods of contraception throughout the study and within 3 weeks after its completion. |
|
| ExclusionCriteria |
| Details |
1 Subjects requiring initial treatment for COPD.
2 Hypersensitivity to Glycopyrronium bromide or any of the components of the drug.
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).
14Cystic fibrosis, bronchiectasis, pneumoconiosis, or other history of lung ventilation limitations.
15 Found deficiency of α1-antitrypsin.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The variation value for FEV1 indicator |
at Visits 1 and 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dynamics of FEV1 indicator |
for 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 the severity of dyspnea according to the MRC scale |
for Visits 2, 3, and 4. |
| The frequency of subjects with exacerbations |
Visits 2, 3, and 4 |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="230"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/11/2021 |
| 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 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. 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. |