Long Term Safety Study of NVA237 vs QAB149 in COPD Patients

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Glycopyrrolate

Criteria

Inclusion Criteria:

1. Male or female patients with COPD according to GOLD 2011 who have signed informed consent.

2. Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.

3. Current or ex-smokers with a smoking history of at least 10 pack years

4. Patients with a mMRC score of at least 2 at run-in.

Exclusion Criteria:

1. Patients contraindicated for muscarinic antagonist agents and beta-2 agonists

2. Patients with a history of malignancy of any organ system, treated or untreated, within the last five years

3. Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention

4. Patients who had a COPD exacerbation within 6 weeks prior to screening.

5. Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.

6. Patients with a history of asthma.

7. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40 years of age.

8. Patients with a blood eosinophil count of greater than 600 mm/3 during run-in

9. Patients with concomitant pulmonary disease

10. Patients with a history of certain cardiovascular co-morbid conditions

11. Patients with a diagnosis of alpha-1 anti-trypsin deficiency

12. Patients with active pulmonary tuberculosis

13. Patients in the active phase of a pulmonary rehabilitation programme

14. Other protocol-defined inclusion / exclusion criteria may apply