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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
CNVA237AAU01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)
Timepoint [1] 0 0
baseline, 12 weeks
Secondary outcome [1] 0 0
Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)
Timepoint [1] 0 0
baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [2] 0 0
Change From Baseline in Mean Trough FEV1
Timepoint [2] 0 0
baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [3] 0 0
Change From Baseline in Total Score of the St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use
Timepoint [4] 0 0
baseline, 12 weeks
Secondary outcome [5] 0 0
Mean Percentage of Nights With 'no Nighttime Awakenings'
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Mean Percentage of Days With Performance of Usual Activities
Timepoint [6] 0 0
12 weeks

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)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
773
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Baulkham Hills
Recruitment hospital [2] 0 0
Novartis Investigative Site - Brookvale
Recruitment hospital [3] 0 0
Novartis Investigative Site - Castle Hill
Recruitment hospital [4] 0 0
Novartis Investigative Site - Dapto
Recruitment hospital [5] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [6] 0 0
Novartis Investigative Site - Ermington
Recruitment hospital [7] 0 0
Novartis Investigative Site - Gosford
Recruitment hospital [8] 0 0
Novartis Investigative Site - Hinchinbrook
Recruitment hospital [9] 0 0
Novartis Investigative Site - Kingswood
Recruitment hospital [10] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [11] 0 0
Novartis Investigative Site - Arundel
Recruitment hospital [12] 0 0
Novartis Investigative Site - Aspley
Recruitment hospital [13] 0 0
Novartis Investigative Site - Beenleigh
Recruitment hospital [14] 0 0
Novartis Investigative Site - Browns Plains
Recruitment hospital [15] 0 0
Novartis Investigative Site - Chemside
Recruitment hospital [16] 0 0
Novartis Investigative Site - Deception Bay
Recruitment hospital [17] 0 0
Novartis Investigative Site - Everton Plaza
Recruitment hospital [18] 0 0
Novartis Investigative Site - Holland Park
Recruitment hospital [19] 0 0
Novartis Investigative Site - Jimboomba
Recruitment hospital [20] 0 0
Novartis Investigative Site - Kedron
Recruitment hospital [21] 0 0
Novartis Investigative Site - Kenmore
Recruitment hospital [22] 0 0
Novartis Investigative Site - Kippa Ring
Recruitment hospital [23] 0 0
Novartis Investigative Site - Logan Central
Recruitment hospital [24] 0 0
Novartis Investigative Site - Loganholme
Recruitment hospital [25] 0 0
Novartis Investigative Site - Mermaid Beach
Recruitment hospital [26] 0 0
Novartis Investigative Site - Morayfield
Recruitment hospital [27] 0 0
Novartis Investigative Site - Nerang
Recruitment hospital [28] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [29] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [30] 0 0
Novartis Investigative Site - Daw Park
Recruitment hospital [31] 0 0
Novartis Investigative Site - Glenelg East
Recruitment hospital [32] 0 0
Novartis Investigative Site - Golden Grove
Recruitment hospital [33] 0 0
Novartis Investigative Site - Hamley Bridge
Recruitment hospital [34] 0 0
Novartis Investigative Site - Kensington Gardens
Recruitment hospital [35] 0 0
Novartis Investigative Site - Prospect
Recruitment hospital [36] 0 0
Novartis Investigative Site - Dandenong
Recruitment hospital [37] 0 0
Novartis Investigative Site - Lalor
Recruitment hospital [38] 0 0
Novartis Investigative Site - Malvern
Recruitment hospital [39] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [40] 0 0
Novartis Investigative Site - Noble Park
Recruitment hospital [41] 0 0
Novartis Investigative Site - Oakleigh East
Recruitment hospital [42] 0 0
Novartis Investigative Site - Preston
Recruitment hospital [43] 0 0
Novartis Investigative Site - Rosebud
Recruitment hospital [44] 0 0
Novartis Investigative Site - Bicton
Recruitment hospital [45] 0 0
Novartis Investigative Site - East Fremantle
Recruitment hospital [46] 0 0
Novartis Investigative Site - East Victoria Park
Recruitment hospital [47] 0 0
Novartis Investigative Site - Fremantle
Recruitment hospital [48] 0 0
Novartis Investigative Site - Mirrabooka
Recruitment hospital [49] 0 0
Novartis Investigative Site - Morley
Recruitment hospital [50] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [51] 0 0
Novartis Investigative Site - Noranda
Recruitment hospital [52] 0 0
Novartis Investigative Site - Perth
Recruitment hospital [53] 0 0
Novartis Investigative Site - Pinjarra
Recruitment hospital [54] 0 0
Novartis Investigative Site - Spearwood
Recruitment hospital [55] 0 0
Novartis Investigative Site - Woodvale
Recruitment hospital [56] 0 0
Novartis Investigative Site - Yokine
Recruitment postcode(s) [1] 0 0
2153 - Baulkham Hills
Recruitment postcode(s) [2] 0 0
2100 - Brookvale
Recruitment postcode(s) [3] 0 0
2067 - Castle Hill
Recruitment postcode(s) [4] 0 0
- Dapto
Recruitment postcode(s) [5] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [6] 0 0
- Ermington
Recruitment postcode(s) [7] 0 0
2250 - Gosford
Recruitment postcode(s) [8] 0 0
2168 - Hinchinbrook
Recruitment postcode(s) [9] 0 0
2747 - Kingswood
Recruitment postcode(s) [10] 0 0
2089 - Sydney
Recruitment postcode(s) [11] 0 0
4214 - Arundel
Recruitment postcode(s) [12] 0 0
4034 - Aspley
Recruitment postcode(s) [13] 0 0
4207 - Beenleigh
Recruitment postcode(s) [14] 0 0
4118 - Browns Plains
Recruitment postcode(s) [15] 0 0
4032 - Chemside
Recruitment postcode(s) [16] 0 0
4508 - Deception Bay
Recruitment postcode(s) [17] 0 0
4053 - Everton Plaza
Recruitment postcode(s) [18] 0 0
4121 - Holland Park
Recruitment postcode(s) [19] 0 0
4032 - Jimboomba
Recruitment postcode(s) [20] 0 0
- Kedron
Recruitment postcode(s) [21] 0 0
4069 - Kenmore
Recruitment postcode(s) [22] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [23] 0 0
4114 - Logan Central
Recruitment postcode(s) [24] 0 0
4129 - Loganholme
Recruitment postcode(s) [25] 0 0
4218 - Mermaid Beach
Recruitment postcode(s) [26] 0 0
4506 - Morayfield
Recruitment postcode(s) [27] 0 0
4211 - Nerang
Recruitment postcode(s) [28] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [29] 0 0
5000 - Adelaide
Recruitment postcode(s) [30] 0 0
5041 - Daw Park
Recruitment postcode(s) [31] 0 0
5045 - Glenelg East
Recruitment postcode(s) [32] 0 0
5125 - Golden Grove
Recruitment postcode(s) [33] 0 0
5401 - Hamley Bridge
Recruitment postcode(s) [34] 0 0
5065 - Kensington Gardens
Recruitment postcode(s) [35] 0 0
5082 - Prospect
Recruitment postcode(s) [36] 0 0
- Dandenong
Recruitment postcode(s) [37] 0 0
3075 - Lalor
Recruitment postcode(s) [38] 0 0
3144 - Malvern
Recruitment postcode(s) [39] 0 0
- Melbourne
Recruitment postcode(s) [40] 0 0
3174 - Noble Park
Recruitment postcode(s) [41] 0 0
3166 - Oakleigh East
Recruitment postcode(s) [42] 0 0
- Preston
Recruitment postcode(s) [43] 0 0
3063 - Rosebud
Recruitment postcode(s) [44] 0 0
- Bicton
Recruitment postcode(s) [45] 0 0
6158 - East Fremantle
Recruitment postcode(s) [46] 0 0
6101 - East Victoria Park
Recruitment postcode(s) [47] 0 0
6160 - Fremantle
Recruitment postcode(s) [48] 0 0
6061 - Mirrabooka
Recruitment postcode(s) [49] 0 0
6062 - Morley
Recruitment postcode(s) [50] 0 0
6009 - Nedlands
Recruitment postcode(s) [51] 0 0
- Noranda
Recruitment postcode(s) [52] 0 0
6000 - Perth
Recruitment postcode(s) [53] 0 0
6069 - Perth
Recruitment postcode(s) [54] 0 0
- Perth
Recruitment postcode(s) [55] 0 0
- Pinjarra
Recruitment postcode(s) [56] 0 0
6163 - Spearwood
Recruitment postcode(s) [57] 0 0
6026 - Woodvale
Recruitment postcode(s) [58] 0 0
6060 - Yokine
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin
Country [4] 0 0
New Zealand
State/province [4] 0 0
Grafton, Auckland
Country [5] 0 0
New Zealand
State/province [5] 0 0
Hamilton
Country [6] 0 0
New Zealand
State/province [6] 0 0
Tauranga
Country [7] 0 0
New Zealand
State/province [7] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01513460