A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo


Tracking Information

Start Date  ICMJEOctober 2009
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2009)		Trough Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01005901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 30, 2009)
  • Transition Dyspnea Index (TDI) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • George's Respiratory Questionnaire (SGRQ) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
Official Title  ICMJEA 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary

A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition  ICMJEChronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Glycopyrronium bromide
    Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI)
  • Drug: Placebo
    Placebo delivered once daily via SDDPI
Study Arms / Comparison Groups
  • NVA237A: Experimental
    Intervention: Drug: Glycopyrronium bromide
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE800
Completion Date 
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

  • 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) < 70%

Exclusion Criteria:

  1. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
  2. Patients with concomitant pulmonary disease
  3. Patients with a history of asthma
  4. Any patient with lung cancer or a history of lung cancer
  5. Patients with a history of certain cardiovascular comorbid conditions
  6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
  7. Patients in the active phase of a supervised pulmonary rehabilitation program
  8. Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply
GenderBoth
Ages40 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis Pharmaceuticals862-778-8300
Location Countries  ICMJEUnited States,   Australia,   Canada,   Japan,   Korea, Republic of,   Netherlands,   Romania,   Russian Federation,   Singapore,   Spain,   Turkey

Administrative Information

NCT ID  ICMJENCT01005901
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECNVA237A2304, EUDRACT Number: 2009-013504-32
Study Sponsor  ICMJENovartis
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByNovartis