Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) (FAST)

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Tiotropium; Drug: Salbutamol; Drug: Placebo to NVA237; Drug: Placebo to tiotropium; Drug: NVA237

Study type: Interventional

Funder types: Industry

Identifiers

NCT01922271

CNVA237ADE02

Details and patient eligibility

About

The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.

Enrollment: 152 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female adults aged ≥40 years
• Patients with moderate to severe COPD defined by a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of <0.70 and a post-bronchodilator FEV1 of ≤70% and FEV1 ≥ 30% of predicted normal values.
• Current or ex-smokers who have a smoking history of at least 10 pack years.

Exclusion criteria

• Pregnant or nursing (lactating) women
• Patients who have a clinically significant laboratory abnormality at run-in
• Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).
• Patients with any history of asthma
• Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
• Patients receiving medications in the classes listed in the protocol as prohibited.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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152 participants in 2 patient groups

NVA237 followed by tiotropium

Experimental group

Description:

Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.

Treatment:

Drug: NVA237

Drug: Placebo to tiotropium

Drug: Tiotropium

Drug: Salbutamol

Tiotropium followed by NVA237

Experimental group

Description:

Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.

Treatment:

Drug: Placebo to NVA237

Drug: Salbutamol