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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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2 March 2015 |
Main ID: |
EUCTR2012-003347-30-SI |
Date of registration:
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14/03/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A multi-centre randomized double blind 12-week study to assess the efficacy, safety and tolerability of QVA149 in patients with COPD who have moderate to severe airflow limitation
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Scientific title:
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A 12-week treatment, multi-center, randomized, double-blind, parallel group, placebo and active controlled study to assess the efficacy, safety, and tolerability of QVA149 (indacaterol maleate /glycopyrronium bromide) in COPD patients with moderate to severe airflow limitation |
Date of first enrolment:
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18/05/2013 |
Target sample size:
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1000 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003347-30 |
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: 4
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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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Egypt
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France
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Guatemala
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Hungary
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Mexico
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Panama
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Slovakia
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Slovenia
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United States
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Venezuela, Bolivarian Republic of
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Key inclusion & exclusion criteria
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Inclusion criteria: •Male and female patients that have signed informed consent and are >/= 40 years of age.
•Patients with stable Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2011.
•Patients with a post-bronchodilator Force Expiratory Volume in one second (FEV1) of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/ Forced Vital capacity (FVC) <0.70.
•Current or ex-smokers who have a smoking history of at least 10 pack years.
•Patients with an mMRC grade 2 or greater.
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 520 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 480
Exclusion criteria: •Patients contraindicated for muscarinic antagonist agents and beta-2 agonists.
•Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
•Patients with narrow-angle glaucoma, Benign Prostatic Hyperplasia (BPH) or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
•Patients who had a COPD exacerbation within 6 weeks prior to screening.
•Patients who have a respiratory tract infection within 4 weeks prior to screening.
•Patients requiring long term oxygen therapy prescribed for more than 12 hour per day.
•Patients with a history of asthma.
•Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
•Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
•Patients with concomitant pulmonary disease.
•Patients with a history of certain cardiovascular co-morbid conditions
•Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
•Patients with active pulmonary tuberculosis.
•Patients in the active phase of a pulmonary rehabilitation programme.
•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: 15.1
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: 12.5- INN or Proposed INN: INDACATEROL MALEATE CAS Number: 753498-25-8 Current Sponsor code: QAB149 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 27.5- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use
Product Name: Indacaterol Product Code: QAB149 Pharmaceutical Form: Inhalation powder, hard capsule CAS Number: 753498-25-8 Current Sponsor code: QAB149 Other descriptive name: INDACATEROL MALEATE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use
Product Name: Glycopyrronium bromide Product Code: NVA237 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: 12.5- 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: Key secondary objective: To demonstrate the superiority of QVA149 27.5/12.5 µg b.i.d. compared to placebo at Week12 in terms of the change in Health Status, based on total score as well as the percentage of patients with clinically significant improvement, as reported by the patients using the SGRQ. Secondary objectives - To evaluate the superiority of QVA149 27.5/12.5 µg b.i.d., QAB149 27.5 µg b.i.d. and NVA237 12.5 µg b.i.d. compared to placebo in terms of standardized FEV1AUC0-12 at Wk 12. - To evaluate the superiority of QVA149 27.5/12.5 µg b.i.d., QAB149 27.5 µg b.i.d. and NVA237 12.5 µg b.i.d. compared to placebo in terms of the following endpoints: -trough FEV1 (mean of 23 h 15 min and 23 h 45 min post morning dose) at Wk 12 -pre-dose trough FEV1 (mean of 15 min and 45 min pre morning dose) at Week 12 -Trough FEV1 (mean of 23 h 15 min and 23 h 45 min post morning dose) after Day1 -FEV1 and FVC at any time point Other secondary objectives listed in the protocol may apply
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Main Objective: To demonstrate the superiority of QVA149 27.5/12.5 µg b.i.d. compared to monotherapy components, QAB149 27.5 µg b.i.d. and NVA237 12.5 µg b.i.d., in terms of standardized FEV1AUC0-12 at Week 12.
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Primary end point(s): Standardized Forced Expiratory Volume in one second Area Under the Curve (AUC) following 12 weeks of treatment.
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Timepoint(s) of evaluation of this end point: Timeframe : 12 weeks
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Timeframe :
1.2.3.4.5.6.7.9.10.11 : 12 weeks
8 : day 1
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Secondary end point(s): 1-Total St. George's Respiratory Questionnaire score
2-Trough Forced Expiratory Volume in one second
3-Pre-dose trough Forced Expiratory Volume in one second
4-Transitional Dyspnea Index focal score
5-Number of puffs of rescue medication
6-Daily symptoms score
7-Trough Forced Expiratory Volume in one second
8-Forced Expiratory Volume in one second at any time point
9-Morning symptoms score
10-Evening symptoms scores
11-Forced Vital Capacity at different time points
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Secondary ID(s)
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2012-003347-30-HU
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CQVA149A2337
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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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