Glycopyrronium bromide plus Indacaterol

Not Applicable

• Conditions: Health Condition 1: J452- Mild intermittent asthma

• Registration Number: CTRI/2021/12/038978
• Lead Sponsor: PSK Pharma LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified