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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
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.
Trial website
https://clinicaltrials.gov/study/NCT01513460
Trial related presentations / publications
Frith PA, Thompson PJ, Ratnavadivel R, Chang CL, Bremner P, Day P, Frenzel C, Kurstjens N; Glisten Study Group. Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial. Thorax. 2015 Jun;70(6):519-27. doi: 10.1136/thoraxjnl-2014-206670. Epub 2015 Apr 3.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01513460