Glycopyrronium bromide 50 μg inhalation powder capsules
- Conditions
- Health Condition 1: J452- Mild intermittent asthma
- Registration Number
- CTRI/2021/11/038151
- Lead Sponsor
- PSK Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The variation value for FEV1 indicatorTimepoint: at Visits 1 and 4
- Secondary Outcome Measures
Name Time Method Dynamics of FEV1 indicatorTimepoint: for Visits 2, 3 and 4;Dynamics of the absolute PEF indicatorTimepoint: for Visits 2, 3 and 4.;Dynamics of the severity of dyspnea according to the MRC scaleTimepoint: for Visits 2, 3, and 4.;Dynamics of the total CAT scoreTimepoint: for Visits 2, 3, and 4.;The frequency of subjects with exacerbationsTimepoint: Visits 2, 3, and 4