Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: NVA237 50µg once daily; Drug: Tiotropium 18µg once daily; Drug: NVA237 placebo + Tiotropium placebo.; Drug: Flu/Sal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01513460

CNVA237AAU01

Details and patient eligibility

About

This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.

Enrollment: 773 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD 2010 guideline
• Current or ex-smokers who have a smoking history of at least 10 pack years
• Qualifying FEV1 at Visit 2 (day -7)

Exclusion criteria

• Patients with a history of asthma or a history of high blood eosinophil count (>600/mm³)
• Patients with concomitant pulmonary disease
• Patients with lung lobectomy or lung volume reduction or lung transplantation
• Patients with α-1 antitrypsin deficiency
• Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during run-in period

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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773 participants in 3 patient groups, including a placebo group

NVA237 + Fluticasone/Salmeterol (Flu/Sal)

Experimental group

Description:

NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

Treatment:

Drug: NVA237 50µg once daily

Drug: Flu/Sal

Drug: NVA237 placebo + Tiotropium placebo.

Tiotropium + Flu/Sal

Active Comparator group

Description:

Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

Treatment:

Drug: Flu/Sal

Drug: Tiotropium 18µg once daily

Drug: NVA237 placebo + Tiotropium placebo.

Flu/Sal

Placebo Comparator group

Description:

Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

Treatment:

Drug: Flu/Sal

Drug: NVA237 placebo + Tiotropium placebo.