Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 July 2015 |
Main ID: |
EUCTR2012-002057-38-EE |
Date of registration:
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06/09/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
Date of first enrolment:
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08/10/2012 |
Target sample size:
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1224 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002057-38 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Countries of recruitment
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Argentina
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Colombia
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Croatia
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Dominican Republic
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Estonia
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Guatemala
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Hungary
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India
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Ireland
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Israel
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Korea, Republic of
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Latvia
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Lithuania
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Mexico
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Panama
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Poland
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Russian Federation
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Serbia
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Slovenia
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Turkey
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United Kingdom
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Venezuela, Bolivarian Republic of
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Contacts
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Name:
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DRA
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Address:
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Pärnu mnt. 141
11314
Tallinn
Estonia |
Telephone:
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+3726630814 |
Email:
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dra.estonia@novartis.com |
Affiliation:
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Novartis Pharma Services Inc, Estonian affiliate |
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Name:
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DRA
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Address:
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Pärnu mnt. 141
11314
Tallinn
Estonia |
Telephone:
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+3726630814 |
Email:
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dra.estonia@novartis.com |
Affiliation:
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Novartis Pharma Services Inc, Estonian affiliate |
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Key inclusion & exclusion criteria
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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
Other protocol defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 612 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 612
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 ß2 agonists
Other protocol defined exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 14.1
Level: LLT
Classification code 10010952
Term: COPD
System Organ Class: 100000004855
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Intervention(s)
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Product Name: Indacaterol maleate/Glycopyrronium bromide Product Code: QVA149 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: GLYCOPYRRONIUM BROMIDE CAS Number: 596-51-0 Current Sponsor code: NVA237 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50- CAS Number: 753498-25-8 Current Sponsor code: QAB149 Other descriptive name: INDACATEROL MALEATE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 110- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use
Trade Name: Spiriva Handihaler Product Name: Spiriva Handihaler Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: TIOTROPIUM BROMIDE CAS Number: 139404-48-1 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 18- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use
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Primary Outcome(s)
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Secondary Objective: 1. To evaluate QVA149 110/50 µg qd compared to placebo in terms of a composite endpoint of all-cause mortality, and serious CCV events. 2. To evaluate the relative effect of treatment QVA149 compared to placebo and tiotropium on safety and tolerability during 52 weeks of treatment. 3. To compare the bronchodilator effect of QVA149 with tiotropium and placebo based on the mean pre-dose FEV1 at week 52. 4. To assess changes in health status as measured by the St. George’s Respiratory Questionnaire for COPD patients (SGRQ-C) after 52 weeks of treatment with QVA149 compared with tiotropium and placebo. 5. To compare the effect of QVA149 with tiotropium and placebo on patient reported symptoms during the treatment period. 6. To compare the bronchodilator effect of QVA149 with tiotropium and placebo based on FVC and FEV1 measurements at all post-baseline time points. 7. To compare the effect of QVA149 with placebo on time to premature discontinuation.
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Timepoint(s) of evaluation of this end point: 56 weeks
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Main Objective: To demonstrate the non-inferiority of QVA149 110/50 µg qd compared to placebo in terms of overall SAE rate from initiation of study treatment through 30 days post last treatment.
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Primary end point(s): Overall serious adverse event rate
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. weeks 1, 26 and 52
2. 52 weeks
3. 52 weeks
4. 52 weeks
5. 52 weeks
6. 52 weeks
7. Weeks 3, 6, 12, 26, 39 and 52
8. Weeks 3, 6, 12, 26, 39 and 52
9. Weeks 3, 6, 12, 26, 39 and 52
10. Weeks 3, 6, 12, 26, 39 and 52
11. 52 weeks
12. Weeks 3, 6, 12, 26, 39 and 52
13. Weeks 3, 6, 12, 26, 39 and 52
14. 56 weeks
15. Weeks 3, 6, 12, 26, 39 and 52
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Secondary end point(s): 1. Electrocardiogram
2. Health Status as measured by St. George's Respirator Questionnaire for COPD patients (SGRQ-C) for COPD patients
3. Impairment of health status daily, morning and evening symptom scores
4. Percentage of nights with ‘no nighttime awakenings'
5. Percentage of days with ‘no daytime symptoms’
6. Percentage of ‘days able to perform usual daily activities’
7. Pre-Dose forced expiratory volume over in second (FEV1)
8. Pre-Dose forced vital capacity (FVC)
9. Post dose forced expiratory volume in one second (FEV1)
10. Post Dose forced vital capacity (FVC)
11. Time to discontinuation
12. Radial Pulse Rate
13. Lab values
14. Composite endpoint of all-cause mortality and serious cerebrocardiovascular events
15. Blood Pressure
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Secondary ID(s)
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2012-002057-38-SI
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CQVA149A2339
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Source(s) of Monetary Support
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Novartis Pharma Service AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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