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Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01119950
First received: May 5, 2010
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
  Purpose

This study is designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: NVA237
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the relationship of NVA237 on trough forced expiratory volume in one second (FEV1) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the relationship of NVA237 on FEV1 AUC0-24 hours [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of NVA237 over the course of treatment [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety and tolerability based on adverse events, vital signs, ECG, and laboratory evaluations


Enrollment: 387
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVA237 group 1 Drug: NVA237
Experimental: NVA237 group 2 Drug: NVA237
Experimental: NVA237 group 3 Drug: NVA237
Experimental: NVA237 group 4 Drug: NVA237
Experimental: NVA237 group 5 Drug: NVA237
Experimental: NVA237 group 6 Drug: NVA237
Experimental: NVA237 group 7 Drug: NVA237
Experimental: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female patients age 40 years or more
  • Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
  • 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) <0.7

Exclusion Criteria:

  • Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to the first visit
  • Patients who have had a respiratory tract infection within 4 weeks prior to the first visit
  • Patients with concomitant pulmonary disease or a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular comorbid conditions
  • Patients with eczema, known high IgE levels or a known positive skin prick test
  • Patients participating in the active phase of a pulmonary rehabilitation programme
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119950

  Show 29 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01119950     History of Changes
Other Study ID Numbers: CNVA237A2208, 2009-014038-11
Study First Received: May 5, 2010
Last Updated: October 27, 2011
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Romania: National Medicines Agency

Keywords provided by Novartis:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013