Trial record 1 of 1429 for:    QUANTIFY
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The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD) (QUANTIFY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01574651
First received: April 6, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: QVA149
Drug: Placebo to tiotropium
Drug: Placebo to formoterol
Drug: Tiotropium
Drug: Formoterol
Drug: Placebo to QVA149
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 26-week Treatment, Multicenter, Randomized, Parallel Group, Blinded Study to Assess the Efficacy and Safety of QVA149 (110/50 µg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium Plus Formoterol as an Active Control

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The change from baseline of quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Improvement in Transition Dyspnea Index (TDI) score [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 933
Study Start Date: May 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: QVA149
QVA149 is administered via a single-dose dry powder inhaler
Drug: Placebo to tiotropium
Placebo to tiotropium is administered via the manufacturer's proprietary inhalation device.
Drug: Placebo to formoterol
Placebo to formoterol is administered via the manufacturer's proprietary inhalation device.
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.
Drug: Tiotropium
Tiotropium is administered via the manufacturer's proprietary inhalation device.
Drug: Formoterol
Formoterol 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574651

  Show 143 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01574651     History of Changes
Other Study ID Numbers: CQVA149ADE01, 2011-004870-26
Study First Received: April 6, 2012
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Keywords provided by Novartis:
QVA149
Health related quality of life
Formoterol
Tiotropium
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Tiotropium
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on April 17, 2014