Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: NVA237 100.0 µg once daily; Drug: NVA237 50.0 µg once daily; Drug: Placebo to NVA237 once daily; Drug: NVA237 25.0 µg twice daily; Drug: NVA237 12.5 µg twice daily; Drug: NVA237 12.5 µg once daily; Drug: NVA237 50.0 µg twice daily; Drug: NVA237 25.0 µg once daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT01119950

2009-014038-11 (EudraCT Number)

CNVA237A2208

Details and patient eligibility

About

This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.

Enrollment: 388 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients age 40 years or more
• Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008
• Smoking history of at least 10 pack-years
• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value
• Post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.7
• Symptomatic patients, according to daily electronic diary data between visit 2 (Day -8) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3

Exclusion criteria

• Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to the first visit
• Patients who have had a respiratory tract infection within 4 weeks prior to the first visit
• Patients with concomitant pulmonary disease
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular co-morbid conditions
• Patients with a history of asthma or a blood eosinophil count >600/mm3 or onset of symptoms prior to 40 years
• Patients with eczema, known high IgE levels or a known positive skin prick test
• Patients participating in the active phase of a pulmonary rehabilitation programme
• Patients contraindicated for the treatment with anticholinergics, long and short-acting beta-2 agonists or sympathomimetic amines
• Patients with a history of alpha-1 anti-trypsin deficiency
• Patients on long term oxygen therapy (>15hr per day)
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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388 participants in 8 patient groups, including a placebo group

NVA237 12.5 µg q.d.

Experimental group

Description:

NVA237 12.5 µg once daily

Treatment:

Drug: NVA237 12.5 µg once daily

NVA237 25.0 µg q.d.

Experimental group

Description:

NVA237 25.0 µg once daily

Treatment:

Drug: NVA237 25.0 µg once daily

NVA237 12.5 µg b.i.d.

Experimental group

Description:

NVA237 12.5 µg twice daily

Treatment:

Drug: NVA237 12.5 µg twice daily

NVA237 50.0 µg q.d.

Experimental group

Description:

NVA237 50.0 µg once daily

Treatment:

Drug: NVA237 50.0 µg once daily

NVA237 25.0 µg b.i.d.

Experimental group

Description:

NVA237 25.0 µg twice daily

Treatment:

Drug: NVA237 25.0 µg twice daily

NVA237 100.0 µg q.d.

Experimental group

Description:

NVA237 100.0 µg once daily

Treatment:

Drug: NVA237 100.0 µg once daily

NVA237 50.0 µg b.i.d.

Experimental group

Description:

NVA237 50.0 µg twice daily

Treatment:

Drug: NVA237 50.0 µg twice daily

Placebo

Placebo Comparator group

Description:

Placebo to NVA237 once daily

Treatment:

Drug: Placebo to NVA237 once daily