A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo (GLOW 1)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Glycopyrronium bromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01005901

CNVA237A2304

2009-013504-32 (EudraCT Number)

Details and patient eligibility

About

A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Enrollment: 1,324 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

• Smoking history of at least 10 pack-years
• Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value
• Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion criteria

1. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
2. Patients with concomitant pulmonary disease
3. Patients with a history of asthma
4. Any patient with lung cancer or a history of lung cancer
5. Patients with a history of certain cardiovascular comorbid conditions
6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
7. Patients in the active phase of a supervised pulmonary rehabilitation program
8. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,324 participants in 2 patient groups, including a placebo group

Glycopyrronium bromide

Experimental group

Description:

Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.

Treatment:

Drug: Glycopyrronium bromide

Placebo

Placebo Comparator group

Description:

Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.

Treatment:

Drug: Placebo