1-year Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Chronic Obstructive Pulmonary Disease (COPD)


Tracking Information

Start Date  ICMJEJune 2009
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2009)		Mean 24 h post-dose (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 NCT00929110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: June 25, 2009)
  • 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 ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJE1-year Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJEA 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.
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Condition  ICMJEChronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: NVA237
    50µg once daily
  • Drug: Placebo to NVA
    once daily
  • Drug: Tiotropium
    18µg once daily
Study Arms / Comparison Groups
  • NVA237 50µg once daily: Experimental
    Intervention: Drug: NVA237
  • Placebo to NVA: Placebo Comparator
    Intervention: Drug: Placebo to NVA
  • Tiotropium 18µg once daily: Active Comparator
    Intervention: Drug: Tiotropium

Recruitment Information

Estimated Enrollment  ICMJE1065
Completion Date 
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

GenderBoth
Ages40 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis Pharmaceuticals862-778-8300
Location Countries  ICMJEUnited States,   Argentina,   Canada,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Peru,   Poland,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00929110
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECNVA237A2303, EUDRACT 2008-008394-63
Study Sponsor  ICMJENovartis
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Novartis PharmaceuticalsNovartis Pharmaceuticals
Information Provided ByNovartis