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1-year Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Chronic Obstructive Pulmonary Disease (COPD) (GLOW 2)
This study has been completed.

First Received on June 25, 2009.   Last Updated on November 8, 2011   History of Changes
Sponsor: Novartis
Information provided by (Responsible Party): 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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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 ]
  • Daily rescue medication use (number of puffs) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 1063
Study Start Date: June 2009
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVA237 50µg once daily Drug: NVA237
50µg once daily
Placebo Comparator: Placebo to NVA Drug: Placebo to NVA
once daily
Active Comparator: Tiotropium 18µg once daily 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

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00929110     History of Changes
Other Study ID Numbers: CNVA237A2303, EUDRACT 2008-008394-63
Study First Received: June 25, 2009
Last Updated: November 8, 2011
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:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012