A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: NVA237; Drug: Salbutamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02371629

CNVA237A2320

Details and patient eligibility

About

This study is a post-authorization commitment to the European Medicines Agency (EMA). The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug was tested for twice daily dosing against once daily dosing.

Enrollment: 776 patients

Sex: All

Ages: 41 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed
• Male and female adults aged ≥40 years
• Patients with stable COPD according to the current GOLD strategy (GOLD 2014)
• Current or ex-smokers who have a smoking history of at least 10 pack years- an ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening
• mMRC grade of at least 2 at Visit 101
• Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30 % and < 80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at Visit 101.

Exclusion criteria

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test; Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
• Patients with Type I or uncontrolled Type II diabetes; Patients with a history of long QT syndrome or whose QTc measured at run-in (Fridericia method) is prolonged (>450 ms for males and >460 for females) and confirmed by a central assessor
• Patients requiring long term oxygen therapy prescribed for >12 h per day; Patients with any history of asthma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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776 participants in 2 patient groups

NVA237 Twice daily

Experimental group

Description:

Patients randomized to this arm received an NVA237 22 μg capsule in the morning and evening for 26 weeks. All participants received salbutamol as rescue medicine.

Treatment:

Drug: NVA237

Drug: Salbutamol

NVA237 Once daily

Experimental group

Description:

Patients randomized to this arm received an NVA237 44 μg capsule in the morning and a placebo capsule in the evening for 26 weeks. All participants received salbutamol as rescue medicine.

Treatment:

Drug: NVA237

Drug: Placebo

Drug: Salbutamol