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1-year Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Chronic Obstructive Pulmonary Disease (COPD)
This study is currently recruiting participants.
Verified by Novartis, January 2010
First Received: June 25, 2009   Last Updated: January 27, 2010   History of Changes
Sponsor: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00929110
  Purpose

This study is designed to investigate 1 year efficacy and safety data for the 50µg o.d. dose of NVA237 in patients with moderate to severe chronic obstructive pulmonary disease.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: NVA237
Drug: Placebo to NVA
Drug: Tiotropium
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Official Title: A 52-week Treatment, Randomized, Double-blind, Placebo-controlled, With Open Label Tiotropium, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean 24 h post-dose (trough) forced expiratory volume in 1 second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breathlessness measured using the Transition Dyspnea Index (TDI) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Total score of the St George's Respiratory Questionnaire (SGRQ) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to first COPD exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Daily rescue medication use (number of puffs) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1065
Study Start Date: June 2009
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
NVA237 50µg once daily: Experimental Drug: NVA237
50µg once daily
Placebo to NVA: Placebo Comparator Drug: Placebo to NVA
once daily
Tiotropium 18µg once daily: Active Comparator Drug: Tiotropium
18µg once daily

  Eligibility

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

Inclusion Criteria:

  1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
  2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
  3. Current or ex-smokers who have a smoking history of at least 10 pack years.
  4. Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (day -14)
  5. Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.

Exclusion Criteria:

  1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
  2. Women of child-bearing potential, unless using an approved method of medical or surgical contraception.
  3. Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 (day -21) and Visit 3 (day 1).
  4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (day -21).
  5. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
  6. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at visit 1) and onset of symptoms prior to age 40 years.
  7. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (day -21) (Fridericia method) is prolonged (>450 ms for males or > 470 ms for females

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929110

Contacts
Contact: Novartis Pharmaceuticals 862-778-8300

  Show 139 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CNVA237A2303, EUDRACT 2008-008394-63
Study First Received: June 25, 2009
Last Updated: January 27, 2010
ClinicalTrials.gov Identifier: NCT00929110     History of Changes
Health Authority: United States: Food and Drug Administration;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Belgium: Federal Agency for Medicinal Products and Health Products;   Canada: Health Canada;   Chile: Comisión Nacional de Investigación Científica y Tecnológica;   Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos;   Czech Republic: State Institute for Drug Control;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Hungary: National Institute of Pharmacy;   Israel: Ministry of Health;   Italy: The Italian Medicines Agency;   Korea: Food and Drug Administration;   Malaysia: Ministry of Health;   Mexico: Ministry of Health;   Netherlands: Medicines Evaluation Board (MEB);   New Zealand: Food Safety Authority;   Peru: Ministry of Health;   Philippines: Bureau of Food and Drugs;   Poland: Ministry of Health;   Russia: Ministry of Health and Social Development of the Russian Federation;   South Africa: Department of Health;   Thailand: Food and Drug Administration;   Turkey: Ministry of Health;   Ukraine: Ministry of Health;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
COPD, NVA237, glycopyrronium

Additional relevant MeSH terms:
Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Respiration Disorders
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 09, 2010