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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5 August 2013 |
Main ID: |
EUCTR2011-000960-93-EE |
Date of registration:
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30/04/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy, safety, and tolerability of NVA237 compared to tiotropium in patients with chronic obstructive pulmonary disease (COPD)
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Scientific title:
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A 12-week treatment, randomized, blinded, double-dummy, parallel-group study to assess the efficacy, safety, and tolerability of NVA237 (50 µg o.d.) compared to tiotropium (18 µg o.d.) in patients with chronic obstructive pulmonary disease (COPD) |
Date of first enrolment:
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15/05/2012 |
Target sample size:
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660 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000960-93 |
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: yes
Other trial design description: double dummy
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Argentina
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Canada
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Croatia
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Czech Republic
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Estonia
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Guatemala
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India
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Korea, Republic of
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Latvia
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Lithuania
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Philippines
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Poland
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South Africa
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Taiwan
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Turkey
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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: Inclusion criteria: To be eligible, patients have to fulfill all the criteria.
•Patients with moderate to severe stable COPD (Stage II or Stage III) according to the current GOLD Guidelines (GOLD 2010).
•Patients with a post-bronchodilator FEV1 = 30% and < 80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at screening.
•Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack/day x 10 yrs, or ½ pack/day x 20 yrs).
•Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.
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 330 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 330
Exclusion criteria: 1. Pregnant or nursing (lactating) women.
2. Patients who, in the judgment of the investigator, or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition before Visit 1.
3. Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (BPH patients who are stable on treatment can be considered).
4. Patients receiving medications in the classes listed in the protocol as prohibited.
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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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 14.1
Level: LLT
Classification code 10010952
Term: COPD
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Intervention(s)
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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 Other descriptive name: Glycopyrronium Bromide Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50- 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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Primary end point(s): Trough Forced Expiratory Volume in 1 Second (FEV1)
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Secondary Objective: To demonstrate superiority of NVA237 (50 µg o.d.) vs. tiotropium (18 µg o.d.) on trough FEV1 after 12 weeks of treatment in patients with moderate to severe COPD if the primary objective of non-inferiority is reached.
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Main Objective: To demonstrate non-inferiority of NVA237 50 µg o.d. versus tiotropium 18 µg o.d. with respect to trough Forced Expiratory Volume in one second (trough FEV1) after 12 weeks (84 days) of treatment in patients with moderate to severe COPD (GOLD, 2010). Trough refers to the mean of FEV1 at 23h 15 mins and 23h 45 mins after the morning dose of study drug.
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Timepoint(s) of evaluation of this end point: Timeframe: At 12 weeks
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: a. Timeframe: At 12 weeks
b. c. d. e. Timeframe: Over 12 weeks
f. g. Timeframe: Day 1; Week 4
h. i. j. Timeframe: At individual time-points on Day 1, Week 4 and Week 12
k. Timeframe: Day 1 and Week 12
l. m. n. o. p. q. r. Timeframe: Over 12 weeks
s. Timeframe: Day 1 and Week 12
t. Timeframe: At individual time-points on Days 1, 2, 28,29,84
u. v. Timeframe: 12 weeks
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Secondary end point(s): a. Transition Dyspnea Index (TDI) Focal Score
b. The mean change from baseline in the daily number of puffs of rescue medication
c. The mean change from baseline in the daytime number of puffs of rescue medication.
d. The mean change from baseline in the nighttime number of puffs of rescue medication
e. The percentage of ‘days with no rescue use’
f. Mean trough FEV1
g. Mean peak FEV1
h. FEV1
i. Forced Vital Capacity (FVC)
j. Inspiratory Capacity (IC)
k. FEV1 AUC (5min-4h)
l. Percentage of nights with ‘no nighttime awakenings’
m. Percentage of days with ‘no daytime symptoms’
n. Percentage of ‘days able to perform usual daily activities’
o. Symptom scores
p. Time to first moderate /severe COPD exacerbation
q. Rate of moderate / severe COPD exacerbations
r. Safety variables
s. Electrocardiogram (ECG)
t. Vital Signs (Blood pressure and radial pulse)
u. Laboratory Data
v. Quality of Life Assessment with St George’s Respiratory Questionnaire (SGRQ)
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Secondary ID(s)
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2011-000960-93-CZ
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NVA237A2314
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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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