Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD) (GLOW3)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: NVA237

Study type: Interventional

Funder types: Industry

Identifiers

NCT01154127

CNVA237A2310

2010-018597-20 (EudraCT Number)

Details and patient eligibility

About

The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.

Enrollment: 108 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who signed an Informed Consent Form prior to initiation of any study-related procedure
• Patients with moderate to severe stable COPD (clinical diagnosis in compliance with GOLD 2008)
• Current or ex-smokers with a smoking history ≥ 10 pack years. (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.).
• Patients with a post-bronchodilator FEV1 ≥ 40 and < 70% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 during screening. (Post referred to the highest post-bronchodilator value after inhalation of 80 μg ipratropium bromide)
• Increase in FEV1 from pre- to post-bronchodilator assessment of ≥ 5%

Exclusion criteria

• Pregnant women or nursing mothers
• Women of child-bearing potential
• Patients who had a COPD exacerbation (whether hospitalized or not) in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4
• Patients who had a lower respiratory tract infection in the 6 weeks prior to Visit 1
• Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia
• Patients with resting (5 min) oxygen SaO2 (or SpO2) saturation on room air of < 85%
• Patients with a maximum workload (Wmax) value < 20 W (as determined by the incremental cycle endurance test) at Visit 2.
• Patients whose exercise endurance time at sub-maximal workload was above 25 min at baseline
• Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would have been at potential risk if enrolled into the study
• Patients with a history of long QT syndrome or whose QTc was prolonged (> 450 ms for males and > 470 ms females) at screening (Fredericia's correction)

Other protocol-defined inclusion/exclusion criteria applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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108 participants in 2 patient groups

NVA237 followed by Placebo

Experimental group

Description:

Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days Period 2: Matching placebo via NEOHALER inhaler device for 21 days The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. Salbutamol (albuterol) was used as rescue medication throughout the study.

Treatment:

Drug: Placebo

Drug: NVA237

Placebo followed by NVA237

Experimental group

Description:

Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. Salbutamol (albuterol) was used as rescue medication throughout the study.

Treatment:

Drug: Placebo

Drug: NVA237