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Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01610037
First received: May 30, 2012
Last updated: October 21, 2014
Last verified: September 2014

May 30, 2012
October 21, 2014
October 2012
January 2015   (final data collection date for primary outcome measure)
overall serious adverse event rate [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ]
The overall rate of serious adverse events reported from initiation through 30 days post last dose will be analyzed.
Same as current
Complete list of historical versions of study NCT01610037 on ClinicalTrials.gov Archive Site
  • Composite endpoint of all-cause mortality and serious cerebro-cardiovascular events [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ]
    A composite endpoint of all-cause mortality and serious cerebro-cardiovascular events will be analyzed.
  • Electrocardiogram [ Time Frame: weeks 1, 26 and 52 ] [ Designated as safety issue: Yes ]
    Data from the electrocardiograms will be summarized by treatment at all times.
  • Health Status as measured by St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The St. George's Respiratory Questionnaire (SGRQ-C) will be used to provide the health status measurement. The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to Chronic Obstructive Pulmonary Disease. A score will be calculated for each of these three parts and a "Total" score will also be calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.
  • Daily, morning and evening symptom scores [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Patients will be provided with an electronic diary (eDiary) to record daily clinical symptoms, or rescue medication. The patients will be instructed to routinely complete the patient diary twice daily. There are 9 total symptom questions for a total possible score of 27 at each timepoint. A higher score means the patient is reporting more symptoms related to Chronic Obstructive Pulmonary Disease.
  • Percentage of nights with 'no nighttime awakenings' [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    A night with 'no nighttime awakenings' is defined from diary data as any night where the patient did not wake up due to symptoms. The percentage of nights with 'no nighttime awakenings' will be analyzed.
  • Percentage of days with 'no daytime symptoms' [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    A day with 'no daytime symptoms' is defined from the diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) during the past 12 hours (approx 8 am to 8 pm). The percentage of days with 'no daytime symptoms' will be analyzed.
  • Percentage of 'days able to perform usual daily activities' [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    A 'day able to perform usual daily activities' is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The percentage of 'days able to perform usual daily activities' will be analyzed.
  • Pre-Dose forced expiratory volume over in second (FEV1) [ Time Frame: Weeks 3, 6, 12, 26, 39, and 52 ] [ Designated as safety issue: No ]
    The average pre-dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.
  • Pre-Dose forced vital capacity (FVC) [ Time Frame: Weeks 3, 6, 12, 26, 39 and 52 ] [ Designated as safety issue: No ]
    The average pre-dose forced vital capacity (FVC) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.
  • Post dose forced expiratory volume in one second (FEV1) [ Time Frame: Weeks 3, 6, 12, 26, 39, and 52 ] [ Designated as safety issue: No ]
    The avg 60 min post dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.
  • Post Dose forced vital capacity (FVC) [ Time Frame: Weeks 3, 6, 12, 26, 39, and 52 ] [ Designated as safety issue: No ]
    The avg 60 min post dose forced vital capacity (FVC)at visit 4, 5, 6, 7, 8 and 9 will be analyzed.
  • Time to discontinuation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Time to premature discontinuation will be displayed graphically for each treatment group.
  • Vital Signs [ Time Frame: Weeks 3, 6, 12, 26, 39, and 52 ] [ Designated as safety issue: Yes ]
    Vital signs (blood pressure and radial pulse rate) data will be summarized by treatment at pre-dose and 30 minute post-dose time points at Visits 3-9.
  • Lab values [ Time Frame: Weeks 6, 12, 26, 39, and 52 ] [ Designated as safety issue: Yes ]
    All lab data will be listed with abnormal values flagged. The lab values and the change from baseline for continuous lab parameters will be summarized at each visit. A frequency table of results for categorical lab parameters will be produced by visit. Shift tables relative to normal ranges will be used to summarize the change from baseline to post-baseline by visit.
  • Electrocardiogram [ Time Frame: Weeks 1, 26 and 52 ] [ Designated as safety issue: No ]
    Data from the electrocardiograms will be summarized by treatment at all times.
  • Health Status as measured by Saint George's Respiratory Questionnaire (SGRQ-C) for Chronic Obstructive Pulmonary Disease (COPD) patients [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The Saint George's Respiratory Questionnaire (SGRQ-C) will be used to provide the health status measurement. The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to Chronic Obstructive Pulmonary Disease. A score will be calculated for each of these three parts and a "Total" score will also be calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status
  • Impairment of health status daily, morning and evening symptom scores [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Patients will be provided with an electronic diary (eDiary) to record daily clinical symptoms, or rescue medication. The patients will be instructed to routinely complete the patient diary twice daily. There are 9 total symptom questions for a total possible score of 27 at each timepoint. A higher score means the patient is reporting more symptoms related to Chronic Obstructive Pulmonary Disease.
  • Percentage of nights with 'no nighttime awakenings' [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    A night with 'no nighttime awakenings' is defined from diary data as any night where the patient did not wake up due to symptoms. The percentage of nights with 'no nighttime awakenings' will be analyzed.
  • Percentage of days with 'no daytime symptoms' [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    A day with 'no daytime symptoms' is defined from the diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) during the past 12 hours (approx 8 am to 8 pm). The percentage of days with 'no daytime symptoms' will be analyzed.
  • Percentage of 'days able to perform usual daily activities' [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    A 'day able to perform usual daily activities' is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The percentage of 'days able to perform usual daily activities' will be analyzed.
  • Pre-dose Forced Expiratory Volume in one second (FEV1) [ Time Frame: Weeks 3, 6, 12, 26, 39, and 52 ] [ Designated as safety issue: No ]
    The average pre-dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.
  • Pre-dose Forced Vital Capacity (FVC) [ Time Frame: Weeks 3, 6, 12, 26, 39 and 52 ] [ Designated as safety issue: No ]
    The average pre-dose forced vital capacity (FVC) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.
  • Post dose Forced Expiratory Volume in one second (FEV1) [ Time Frame: Weeks 3, 6, 12, 26, 39, and 52 ] [ Designated as safety issue: No ]
    The average 60 minute post dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed
  • Post dose Forced Vital Capacity (FVC) [ Time Frame: Weeks 3, 6, 12, 26, 39, and 52 ] [ Designated as safety issue: No ]
    The average 60 minute post dose forced vital capacity (FVC)at visit 4, 5, 6, 7, 8 and 9 will be analyzed.
  • Time to discontinuation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Time to premature discontinuation will be displayed graphically for each treatment group.
  • Vital signs [ Time Frame: Weeks 6, 12, 26, 39, and 52 ] [ Designated as safety issue: Yes ]
    Vital signs (blood pressure and radial pulse rate) data will be summarized by treatment at pre-dose and 30 minute post-dose time points at visits 3-9.
  • Lab values [ Time Frame: Weeks 6, 12, 26, 39, and 52 ] [ Designated as safety issue: Yes ]
    All lab data will be listed with abnormal values flagged. The lab values and the change from baseline for continuous lab parameters will be summarized at each visit. A frequency table of results for categorical lab parameters will be produced by visit. Shift tables relative to normal ranges will be used to summarize the change from baseline to post-baseline by visit.
  • Composite endpoint of all-cause mortality and serious cerebro-cardiovascular events [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ]
    A composite endpoint of all-cause mortality and serious cerebro-cardiovascular events will be analyzed.
Not Provided
Not Provided
 
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation

The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • Drug: QVA149
    QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI
  • Drug: Tiotropium
    Tiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI
  • Drug: placebo
    placebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI
  • Experimental: QVA149
    Intervention: Drug: QVA149
  • Active Comparator: Tiotropium
    Intervention: Drug: Tiotropium
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1224
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female adults aged ≥40 yrs
  • Smoking history of at least 10 pack years
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate to severe airflow limitation as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2011)
  • Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
  • Modified Medical Research Council questionnaire grade of 2 or higher

Exclusion Criteria:

  • 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
  • Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
  • Patients in the active phase of a supervised pulmonary rehabilitation program
  • Patients contraindicated for inhaled anticholinergic agents and β2 agonists
  • Other protocol-defined inclusion/exclusion criteria may apply
Both
40 Years and older
No
Contact: Novartis Pharmaceuticals, 1862-778-8300 +41613241111
Contact: Novartis Pharmaceuticals
Argentina,   Colombia,   Croatia,   Dominican Republic,   Estonia,   Guatemala,   Hungary,   India,   Ireland,   Israel,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Panama,   Poland,   Russian Federation,   Serbia,   Slovenia,   Turkey,   United Kingdom
 
NCT01610037
CQVA149A2339, 2012-002057-38
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

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