Efficacy of NVA237 (50 μg o.d) Using Tiotropium (5μg μg o.d) as Active Control in COPD Patients.

NCT01837927 | Withdrawn Phase 3

• 1 other identifier: CNVA237ABR01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as active control in COPD patients.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Efficacy, NVA237, Tiotropium, Chronic Obstructive Pulmonary Disease, COPD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

  Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.

  Baseline and 12 weeks after treatment.

Secondary Outcomes (6)

• Forced Expiratory Volume in 1 Second (FEV1) at day 1

  30 and 60 minutes post-dose on the first day of study treatment.

• Forced Expiratory Volume in 1 Second (FEV1) at day 7 and weeks 12, 24 and 52

  30 and 60 minutes post-dose on the 7th day of study treatment and at weeks 12, 24 and 52

• Forced Expiratory Volume in 1 Second (FEV1) at weeks 24 and 52

  pre-dose at weeks 24 and 52 of study treatment

• Change From Baseline in Forced Vital Capacity (FVC)

  Days 1 and 7, weeks 12, 24 and 52 of study treatment

• FEV1 AUC 0-4h

  05, 30, 60 minutes and 4 hours post-dose at days 1, 7 and week 12

Study Arms (2)

NVA237

EXPERIMENTAL

NVA237 inhaled via the Breezhaler® device once daily

Drug: NVA237

Tiotropium

ACTIVE COMPARATOR

Tiotropium 5μg inhaled via the Respimat® device once daily

Drug: Tiotropium Respimat®

Interventions

NVA237 DRUG

Once daily for 52 weeks

NVA237

Tiotropium Respimat® DRUG

Once daily for 52 weeks

Tiotropium

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 40 years or over.
• History of current or former smoking of at least 10 pack-years

You may not qualify if:

• Pregnant women or nursing mothers
• History of asthma at visit 1 indicated by, but not limited to:
• Onset of respiratory symptoms suggestive of asthma (such as coughing, wheezing, shortness of breath) before the age of 40.
• History of diagnosed asthma
• History of respiratory tract infection within six weeks prior to Visit 1.
• History of hospitalization or emergency care for a COPD exacerbation in the 3 months prior to Visit 1.
• Subjects who require use of home oxygen therapy.
• Patients in the active phase of an assisted pulmonary rehabilitation program and patients who completed the rehabilitation program within 18 months from Visit 1 or 2 of the protocol.17,20
• Patients with known history and diagnosis of alpha-1 antitrypsin deficiency.
• Patients with concomitant lung disease, e.g.: tuberculosis (unless confirmed by radiography as inactive) or clinically significant bronchiectasis.
• Patients who in the investigator's judgment have an abnormality or significant medical condition such as: unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (except chronic stable atrial fibrillation), history of malignancy of any system (including lung cancer) treated or not within the last 5 years, glaucoma, prostatic hyperplasia, moderate to severe renal impairment, urinary retention, any other condition that might compromise patient safety or compliance, interfere with the evaluations, or prevent the termination of their participation in the study.
• Patients with contraindications to tiotropium or ipratropium treatment or who have experienced undesirable reactions with inhaled anticholinergic agents or patients with a history of an undesirable reaction with sympathomimetic amines or inhaled medication with any of those components, or a history of hypersensitivity to any of the study medications, including rescue medication, or similar classes of medication.
• Patients using tiotropium, long-acting anticholinergics, short-acting anticholinergics, fixed combinations of inhaled beta agonists and inhaled corticosteroids, theophylline. In these cases, the patient is allowed, after agreeing to participate in the study, to enter a washout period from Visit
• Patients using inhaled steroids, alone or as an exchange in a fixed combination at equivalent doses, unless on a stable treatment for at least 1 month prior to randomization
• Patients using nonselective beta-blockers.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate; tiotropium-olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-08