Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients (GLOW4)

Novartis

Status and phase

Completed

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: NVA237

Drug: Tiotropium

Study type

Interventional

Funder types

Industry

Identifiers

NCT01119937

CNVA237A1302

Details and patient eligibility

About

This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .

Enrollment

211 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Gold Guideline 2008.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 at Visit 2 (day -7)

Exclusion criteria

Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
Patients requiring long term oxygen therapy
Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
Other protocol-defined inclusion/exclusion criteria may apply