Long Term Safety Study of NVA237 vs QAB149 in COPD Patients

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: NVA237; Drug: Long-acting beta 2-agonist (LABA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01697696

2012-002728-34 (EudraCT Number)

CNVA237A2319

Details and patient eligibility

About

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.

Enrollment: 511 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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511 participants in 2 patient groups

NVA237 dose 1

Experimental group

Description:

NVA237 dose 1

Treatment:

Drug: NVA237

Long-acting beta 2-agonist (LABA)

Active Comparator group

Description:

QAB149

Treatment:

Drug: Long-acting beta 2-agonist (LABA)

Drug: Placebo