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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01513460
Registration number
NCT01513460
Ethics application status
Date submitted
16/01/2012
Date registered
20/01/2012
Date last updated
5/01/2015
Titles & IDs
Public title
Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
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Scientific title
A Multicenter, Randomized, Blinded, Active-controlled, Parallel-group Study to Compare the Efficacy, Tolerability and Safety of NVA237 Compared to Tiotropium Added on to Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease
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Secondary ID [1]
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CNVA237AAU01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - NVA237 50µg once daily
Treatment: Drugs - Tiotropium 18µg once daily
Treatment: Drugs - Flu/Sal
Treatment: Drugs - NVA237 placebo + Tiotropium placebo.
Experimental: NVA237 + Fluticasone/Salmeterol (Flu/Sal) - NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 µg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 µg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting ß2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Active Comparator: Tiotropium + Flu/Sal - Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 µg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 µg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting ß2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Placebo Comparator: Flu/Sal - Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 µg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting ß2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Treatment: Drugs: NVA237 50µg once daily
NVA237 50 µg o.d., delivered via single-dose dry-powder inhaler (SDDPI)
Treatment: Drugs: Tiotropium 18µg once daily
Tiotropium 18 µg o.d. delivered via a proprietary inhalation device
Treatment: Drugs: Flu/Sal
Flu/Sal 500/50 µg b.i.d. delivered via a proprietary inhalation device
Treatment: Drugs: NVA237 placebo + Tiotropium placebo.
Tiotropium 18 µg o.d. delivered via a proprietary inhalation device
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)
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Assessment method [1]
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Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15 hours and 23:45 hours after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45 min and 15 min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.
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Timepoint [1]
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baseline, 12 weeks
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Secondary outcome [1]
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Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)
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Assessment method [1]
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Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.
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Timepoint [1]
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baseline, 4 weeks, 8 weeks, 12 weeks
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Secondary outcome [2]
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Change From Baseline in Mean Trough FEV1
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Assessment method [2]
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Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.
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Timepoint [2]
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baseline, 4 weeks, 8 weeks, 12 weeks
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Secondary outcome [3]
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Change From Baseline in Total Score of the St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment
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Assessment method [3]
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SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest is 100. Higher values corresponded to greater impairment in quality of life. An analysis model included terms for treatment, baseline total SGRQ score, FEV1 and baseline smoking status. The model also contained as fixed effects the baseline total SGRQ score, FEV1 prior to inhalation of short acting bronchodilator, FEV1 post inhalation of short acting bronchodilator and stratification factors as covariates. A negative change from baseline indicates improvement.
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use
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Assessment method [4]
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The total number of puffs of rescue medication used over the last 12 h recorded in the morning (nighttime use) and in the evening (daytime use) over the full 12 weeks was divided by the total number of days with non-missing rescue data to derive the mean daytime and nighttime number of puffs of rescue medication. Change from baseline in the mean daytime and nighttime number of puffs of rescue medication was analyzed as for the change from baseline in the mean daily number of puffs of rescue medication.
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Timepoint [4]
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baseline, 12 weeks
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Secondary outcome [5]
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Mean Percentage of Nights With 'no Nighttime Awakenings'
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Assessment method [5]
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A night with 'no nighttime awakenings' is defined from diary data as any night where patient did not wake up due to symptoms. Total number of nights with 'no nighttime awakenings' over treatment period was divided by total number of nights where diary recordings have been made in order to derive percentage of 'no nighttime awakenings' which will be summarized by treatment and analyzed using a similar mixed model as specified for primary analysis. Diary data recorded during the 7 day run-in period was used to calculate baseline percentage of nights 'no nighttime awakenings'.
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Timepoint [5]
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12 weeks
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Secondary outcome [6]
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Mean Percentage of Days With Performance of Usual Activities
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Assessment method [6]
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A 'day able to perform usual daily activities' was defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The percentage of 'days able to perform usual daily activities' was derived and analyzed using a similar mixed model as specified for primary analysis as for the percentage of nights with 'no nighttime awakenings'.
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Timepoint [6]
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12 weeks
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Eligibility
Key inclusion criteria
- Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD
2010 guideline
- Current or ex-smokers who have a smoking history of at least 10 pack years
- Qualifying FEV1 at Visit 2 (day -7)
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients with a history of asthma or a history of high blood eosinophil count
(>600/mm³)
- Patients with concomitant pulmonary disease
- Patients with lung lobectomy or lung volume reduction or lung transplantation
- Patients with a-1 antitrypsin deficiency
- Patients who have had live attenuated vaccinations within 30 days prior to screening
visit or during run-in period
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2013
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Sample size
Target
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Accrual to date
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Final
773
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Baulkham Hills
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Novartis Investigative Site - Brookvale
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Novartis Investigative Site - Castle Hill
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Novartis Investigative Site - Ermington
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Novartis Investigative Site - Gosford
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Novartis Investigative Site - Hinchinbrook
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Novartis Investigative Site - Deception Bay
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Novartis Investigative Site - Everton Plaza
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Novartis Investigative Site - Holland Park
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Novartis Investigative Site - Jimboomba
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Novartis Investigative Site - Kedron
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Novartis Investigative Site - Kenmore
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Novartis Investigative Site - Kippa Ring
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Novartis Investigative Site - Logan Central
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Novartis Investigative Site - Loganholme
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Novartis Investigative Site - Mermaid Beach
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Novartis Investigative Site - Morayfield
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Novartis Investigative Site - Nerang
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Novartis Investigative Site - Woolloongabba
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Novartis Investigative Site - Daw Park
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Novartis Investigative Site - Golden Grove
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Novartis Investigative Site - Hamley Bridge
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Novartis Investigative Site - Kensington Gardens
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Novartis Investigative Site - Prospect
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Novartis Investigative Site - Noble Park
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Novartis Investigative Site - Oakleigh East
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Novartis Investigative Site - Preston
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Novartis Investigative Site - Rosebud
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Novartis Investigative Site - Bicton
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Novartis Investigative Site - East Victoria Park
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Novartis Investigative Site - Fremantle
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Novartis Investigative Site - Pinjarra
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Novartis Investigative Site - Woodvale
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Novartis Investigative Site - Yokine
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Recruitment postcode(s) [1]
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2153 - Baulkham Hills
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Recruitment postcode(s) [2]
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2100 - Brookvale
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Recruitment postcode(s) [3]
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2067 - Castle Hill
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Recruitment postcode(s) [4]
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- Dapto
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Recruitment postcode(s) [5]
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2010 - Darlinghurst
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Recruitment postcode(s) [6]
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- Ermington
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Recruitment postcode(s) [7]
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2250 - Gosford
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Recruitment postcode(s) [8]
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2168 - Hinchinbrook
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Recruitment postcode(s) [9]
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2747 - Kingswood
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Recruitment postcode(s) [10]
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2089 - Sydney
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Recruitment postcode(s) [11]
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4214 - Arundel
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Recruitment postcode(s) [12]
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4034 - Aspley
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Recruitment postcode(s) [13]
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4207 - Beenleigh
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Recruitment postcode(s) [14]
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4118 - Browns Plains
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Recruitment postcode(s) [15]
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4032 - Chemside
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Recruitment postcode(s) [16]
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4508 - Deception Bay
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Recruitment postcode(s) [17]
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4053 - Everton Plaza
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Recruitment postcode(s) [18]
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4121 - Holland Park
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Recruitment postcode(s) [19]
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4032 - Jimboomba
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Recruitment postcode(s) [20]
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- Kedron
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Recruitment postcode(s) [21]
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4069 - Kenmore
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Recruitment postcode(s) [22]
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4021 - Kippa Ring
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Recruitment postcode(s) [23]
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4114 - Logan Central
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Recruitment postcode(s) [24]
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4129 - Loganholme
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Recruitment postcode(s) [25]
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4218 - Mermaid Beach
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Recruitment postcode(s) [26]
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4506 - Morayfield
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Recruitment postcode(s) [27]
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4211 - Nerang
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Recruitment postcode(s) [28]
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4102 - Woolloongabba
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Recruitment postcode(s) [29]
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5000 - Adelaide
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Recruitment postcode(s) [30]
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5041 - Daw Park
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Recruitment postcode(s) [31]
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5045 - Glenelg East
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Recruitment postcode(s) [32]
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5125 - Golden Grove
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Recruitment postcode(s) [33]
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5401 - Hamley Bridge
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Recruitment postcode(s) [34]
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5065 - Kensington Gardens
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Recruitment postcode(s) [35]
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5082 - Prospect
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Recruitment postcode(s) [36]
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- Dandenong
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Recruitment postcode(s) [37]
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3075 - Lalor
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Recruitment postcode(s) [38]
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3144 - Malvern
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Recruitment postcode(s) [39]
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- Melbourne
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Recruitment postcode(s) [40]
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3174 - Noble Park
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Recruitment postcode(s) [41]
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3166 - Oakleigh East
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Recruitment postcode(s) [42]
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- Preston
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Recruitment postcode(s) [43]
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3063 - Rosebud
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Recruitment postcode(s) [44]
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- Bicton
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Recruitment postcode(s) [45]
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6158 - East Fremantle
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Recruitment postcode(s) [46]
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6101 - East Victoria Park
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Recruitment postcode(s) [47]
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6160 - Fremantle
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Recruitment postcode(s) [48]
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6061 - Mirrabooka
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Recruitment postcode(s) [49]
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6062 - Morley
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Recruitment postcode(s) [50]
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6009 - Nedlands
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- Noranda
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Recruitment postcode(s) [52]
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6000 - Perth
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Recruitment postcode(s) [53]
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6069 - Perth
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Recruitment postcode(s) [54]
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- Perth
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- Pinjarra
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Recruitment postcode(s) [56]
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6163 - Spearwood
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6026 - Woodvale
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Recruitment postcode(s) [58]
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6060 - Yokine
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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State/province [4]
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Grafton, Auckland
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New Zealand
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Hamilton
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Country [6]
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New Zealand
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Tauranga
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New Zealand
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State/province [7]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium
when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary
disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01513460
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Fax
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Email
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Contact person for public queries
Name
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01513460
Download to PDF