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Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations (SPARK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01120691
First received: May 5, 2010
Last updated: October 17, 2012
Last verified: October 2012
History of Changes

May 5, 2010
October 17, 2012
April 2010
September 2012   (final data collection date for primary outcome measure)
Superiority of QVA149 over NVA237 in terms of rate of COPD exacerbations [ Time Frame: 64 to 76 weeks ] [ Designated as safety issue: Yes ]
Superiority of QVA149 over NVA237 in terms of rate of COPD exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01120691 on ClinicalTrials.gov Archive Site
  • Superiority of QVA149 over tiotropium in terms of rate of COPD exacerbations [ Time Frame: 64 to 76 weeks ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of QVA149 versus NVA237 and tiotropium assessed by adverse events, electrocardiogram (ECG), laboratory tests, and vital signs [ Time Frame: 64 to 76 weeks ] [ Designated as safety issue: Yes ]
  • Superiority of QVA149 over NVA237 in terms of time to first COPD exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of QVA149 versus NVA237 assessed by adverse events, electrocardiogram (ECG), laboratory tests, and vital signs [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations
Not Provided

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Once-daily QVA149
  • Drug: once-daily NVA237
  • Drug: once-daily tiotropium
  • Experimental: QVA149
    QVA149
    Intervention: Drug: Once-daily QVA149
  • Active Comparator: NVA237
    NVA237
    Intervention: Drug: once-daily NVA237
  • Active Comparator: open-label tiotropium
    open-label tiotropium
    Intervention: Drug: once-daily tiotropium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3843
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female adults aged ≥40 yrs
  • Severe or very COPD [Stage III or IV 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 < 50% of the predicted normal value and post- bronchodilator FEV1/FVC <70%
  • Documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics

Exclusion Criteria:

  • Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia
  • Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1
  • Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular co-morbid conditions
  • Other protocol-defined inclusion/exclusion criteria may apply
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Austria,   Canada,   Colombia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   Peru,   Philippines,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   South Africa,   Spain,   United Kingdom
 
NCT01120691
CQVA149A2304, 2009-013256-69
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP