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The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD) (QUANTIFY)

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ClinicalTrials.gov Identifier: NCT01574651
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : April 29, 2014
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE April 6, 2012
First Posted Date  ICMJE April 10, 2012
Results First Submitted Date  ICMJE March 27, 2014
Results First Posted Date  ICMJE April 29, 2014
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis). [ Time Frame: Baseline, week 26 ]
SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
The change from baseline of quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) [ Time Frame: 26 weeks ]
The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to COPD: symptoms, activity and impact. A score will be calculated for each of these three subscales and a "total" score will also be calculated. The sum of maximum possible weights for each The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
  • St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis). [ Time Frame: Baseline, week 26 ]
    SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment
  • Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment. [ Time Frame: Week 26 ]
    Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)
  • Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks [ Time Frame: Week 26 ]
    The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment
  • Percent of Participants With at Least One Exacerbation Requiring Hospitalization [ Time Frame: Week 26 ]
    The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.
  • Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period [ Time Frame: Week 26 ]
    The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.
  • Trough FEV1 at Baseline and Week 26 [ Time Frame: Baseline, Week 26 ]
    Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.
  • FEV1 30 Min After the Morning Dose at Baseline and Week 26 [ Time Frame: Baseline, Week 26 ]
    FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.
  • Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C [ Time Frame: Baseline, Week 26 ]
    Part I of the SGRQ-C covers "symptoms" and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived "weight". A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
  • Improvement in Transition Dyspnea Index (TDI) score [ Time Frame: 26 weeks ]
    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9. A negative score indicates deterioration from baseline. A TDI score of 1 is considered to be a clinically significant improvement.
  • Rate of moderate COPD exacerbations [ Time Frame: 26 weeks ]
    Rate is the number of moderate exacerbations per year = total number of moderate exacerbations/total number of treatment years. COPD exacerbations were considered to be moderate if treatment with systemic corticosteroids and/or antibiotics were required.
  • Rate of severe COPD exacerbations [ Time Frame: 26 weeks ]
    Rate is the number of severe exacerbations per year = total number of severe exacerbations/total number of treatment years. COPD exacerbations were considered to be severe if hospitalization were required.
  • Time to first moderate or severe COPD exacerbation [ Time Frame: 26 weeks ]
    The time to the first moderate or severe COPD exacerbation was the study day on which the patient experienced first moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalization were required.
  • Safety and tolerability [ Time Frame: 26 weeks ]
    Safety and tolerability will be evaluated from any adverse events, laboratory tests, physical examination and vital signs.
  • Trough forced expiratory volume in one second (FEV1) [ Time Frame: 26 weeks ]
    The FEV1 will measure the maximum amount of air a patient can blow out of their lungs in 1 second. Trough FEV1 referring to mean of FEV1 at 23 hour 15 minute and 23 hour 45 minute after the morning dose.
  • Forced expiratory volume in one second (FEV1) 30 min after the morning dose [ Time Frame: 26 weeks ]
    The FEV1 will measure the maximum amount of air a patient can blow out of their lungs in 1 second. FEV1 30min refers to spirometry 30 minutes after the morning dose.
  • Symptoms reported by patients using component score of Part I "symptoms" of the St George's Respiratory Questionnaire (SGRQ-C) [ Time Frame: 26 weeks ]
    Part I of the SGRQ-C covers "symptoms" and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived "weight". A score will be calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE A 26-week Treatment, Multicenter, Randomized, Parallel Group, Blinded Study to Assess the Efficacy and Safety of QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Using Tiotropium Plus Formoterol as Control
Brief Summary This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: QVA149
    QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler
  • Drug: Placebo to tiotropium
    Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules
  • Drug: Placebo to formoterol
    Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules.
  • Drug: Tiotropium
    Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device.
  • Drug: Formoterol
    Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device.
  • Drug: Placebo to QVA149
    Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules
Study Arms  ICMJE
  • Experimental: QVA149 plus placebo to tiotropium and placebo to formoterol
    QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
    Interventions:
    • Drug: QVA149
    • Drug: Placebo to tiotropium
    • Drug: Placebo to formoterol
  • Active Comparator: Tiotropium plus Formoterol and placebo to QVA149
    Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
    Interventions:
    • Drug: Tiotropium
    • Drug: Formoterol
    • Drug: Placebo to QVA149
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2014)
934
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2012)
880
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female adults aged ≥ 40 yrs
  • Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines)
  • Smoking history of at least 10 pack years
  • Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

  • Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
  • Patients with a history of long QT syndrome
  • Patients with Type I or uncontrolled Type II diabetes
  • Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
  • Patients with any history of asthma
  • Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
  • Patients with concomitant pulmonary disease
  • Patients requiring long term oxygen therapy (>15 h a day)

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574651
Other Study ID Numbers  ICMJE CQVA149ADE01
2011-004870-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date May 2014

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