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Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NVA237 50µg once daily
Tiotropium 18µg once daily
Flu/Sal
NVA237 placebo + Tiotropium placebo.
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease,, NVA 237,, glycopyrronium,, COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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 α-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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

NVA237 + Fluticasone/Salmeterol (Flu/Sal)

Tiotropium + Flu/Sal

Flu/Sal

Arm Description

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 β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

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 β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

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 β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)
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.

Secondary Outcome Measures

Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)
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.
Change From Baseline in Mean Trough FEV1
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.
Change From Baseline in Total Score of the St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment
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.
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use
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.
Mean Percentage of Nights With 'no Nighttime Awakenings'
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'.
Mean Percentage of Days With Performance of Usual Activities
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'.

Full Information

First Posted
January 16, 2012
Last Updated
December 23, 2014
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01513460
Brief Title
Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease,, NVA 237,, glycopyrronium,, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
773 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NVA237 + Fluticasone/Salmeterol (Flu/Sal)
Arm Type
Experimental
Arm Description
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 β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Arm Title
Tiotropium + Flu/Sal
Arm Type
Active Comparator
Arm Description
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 β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Arm Title
Flu/Sal
Arm Type
Placebo Comparator
Arm Description
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 β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Intervention Type
Drug
Intervention Name(s)
NVA237 50µg once daily
Intervention Description
NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI)
Intervention Type
Drug
Intervention Name(s)
Tiotropium 18µg once daily
Intervention Description
Tiotropium 18 μg o.d. delivered via a proprietary inhalation device
Intervention Type
Drug
Intervention Name(s)
Flu/Sal
Intervention Description
Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device
Intervention Type
Drug
Intervention Name(s)
NVA237 placebo + Tiotropium placebo.
Intervention Description
Tiotropium 18 μg o.d. delivered via a proprietary inhalation device
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)
Description
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.
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)
Description
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.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Change From Baseline in Mean Trough FEV1
Description
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.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Change From Baseline in Total Score of the St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment
Description
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.
Time Frame
12 weeks
Title
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use
Description
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.
Time Frame
baseline, 12 weeks
Title
Mean Percentage of Nights With 'no Nighttime Awakenings'
Description
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'.
Time Frame
12 weeks
Title
Mean Percentage of Days With Performance of Usual Activities
Description
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'.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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 α-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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Baulkham Hills
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia
Facility Name
Novartis Investigative Site
City
Brookvale
State/Province
New South Wales
ZIP/Postal Code
2100
Country
Australia
Facility Name
Novartis Investigative Site
City
Castle Hill
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Novartis Investigative Site
City
Dapto
State/Province
New South Wales
Country
Australia
Facility Name
Novartis Investigative Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Novartis Investigative Site
City
Ermington
State/Province
New South Wales
Country
Australia
Facility Name
Novartis Investigative Site
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Novartis Investigative Site
City
Hinchinbrook
State/Province
New South Wales
ZIP/Postal Code
2168
Country
Australia
Facility Name
Novartis Investigative Site
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Novartis Investigative Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2089
Country
Australia
Facility Name
Novartis Investigative Site
City
Arundel
State/Province
Queensland
ZIP/Postal Code
4214
Country
Australia
Facility Name
Novartis Investigative Site
City
Aspley
State/Province
Queensland
ZIP/Postal Code
4034
Country
Australia
Facility Name
Novartis Investigative Site
City
Beenleigh
State/Province
Queensland
ZIP/Postal Code
4207
Country
Australia
Facility Name
Novartis Investigative Site
City
Browns Plains
State/Province
Queensland
ZIP/Postal Code
4118
Country
Australia
Facility Name
Novartis Investigative Site
City
Chemside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Novartis Investigative Site
City
Deception Bay
State/Province
Queensland
ZIP/Postal Code
4508
Country
Australia
Facility Name
Novartis Investigative Site
City
Everton Plaza
State/Province
Queensland
ZIP/Postal Code
4053
Country
Australia
Facility Name
Novartis Investigative Site
City
Holland Park
State/Province
Queensland
ZIP/Postal Code
4121
Country
Australia
Facility Name
Novartis Investigative Site
City
Jimboomba
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Novartis Investigative Site
City
Kedron
State/Province
Queensland
Country
Australia
Facility Name
Novartis Investigative Site
City
Kenmore
State/Province
Queensland
ZIP/Postal Code
4069
Country
Australia
Facility Name
Novartis Investigative Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
Novartis Investigative Site
City
Logan Central
State/Province
Queensland
ZIP/Postal Code
4114
Country
Australia
Facility Name
Novartis Investigative Site
City
Loganholme
State/Province
Queensland
ZIP/Postal Code
4129
Country
Australia
Facility Name
Novartis Investigative Site
City
Mermaid Beach
State/Province
Queensland
ZIP/Postal Code
4218
Country
Australia
Facility Name
Novartis Investigative Site
City
Morayfield
State/Province
Queensland
ZIP/Postal Code
4506
Country
Australia
Facility Name
Novartis Investigative Site
City
Nerang
State/Province
Queensland
ZIP/Postal Code
4211
Country
Australia
Facility Name
Novartis Investigative Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Novartis Investigative Site
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Novartis Investigative Site
City
Glenelg East
State/Province
South Australia
ZIP/Postal Code
5045
Country
Australia
Facility Name
Novartis Investigative Site
City
Golden Grove
State/Province
South Australia
ZIP/Postal Code
5125
Country
Australia
Facility Name
Novartis Investigative Site
City
Hamley Bridge
State/Province
South Australia
ZIP/Postal Code
5401
Country
Australia
Facility Name
Novartis Investigative Site
City
Kensington Gardens
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Novartis Investigative Site
City
Prospect
State/Province
South Australia
ZIP/Postal Code
5082
Country
Australia
Facility Name
Novartis Investigative Site
City
Dandenong
State/Province
Victoria
Country
Australia
Facility Name
Novartis Investigative Site
City
Lalor
State/Province
Victoria
ZIP/Postal Code
3075
Country
Australia
Facility Name
Novartis Investigative Site
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Novartis Investigative Site
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Novartis Investigative Site
City
Noble Park
State/Province
Victoria
ZIP/Postal Code
3174
Country
Australia
Facility Name
Novartis Investigative Site
City
Oakleigh East
State/Province
Victoria
ZIP/Postal Code
3166
Country
Australia
Facility Name
Novartis Investigative Site
City
Preston
State/Province
Victoria
Country
Australia
Facility Name
Novartis Investigative Site
City
Rosebud
State/Province
Victoria
ZIP/Postal Code
3063
Country
Australia
Facility Name
Novartis Investigative Site
City
Bicton
State/Province
Western Australia
Country
Australia
Facility Name
Novartis Investigative Site
City
East Fremantle
State/Province
Western Australia
ZIP/Postal Code
6158
Country
Australia
Facility Name
Novartis Investigative Site
City
East Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6101
Country
Australia
Facility Name
Novartis Investigative Site
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Novartis Investigative Site
City
Mirrabooka
State/Province
Western Australia
ZIP/Postal Code
6061
Country
Australia
Facility Name
Novartis Investigative Site
City
Morley
State/Province
Western Australia
ZIP/Postal Code
6062
Country
Australia
Facility Name
Novartis Investigative Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Novartis Investigative Site
City
Noranda
State/Province
Western Australia
Country
Australia
Facility Name
Novartis Investigative Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Novartis Investigative Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6069
Country
Australia
Facility Name
Novartis Investigative Site
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Novartis Investigative Site
City
Pinjarra
State/Province
Western Australia
Country
Australia
Facility Name
Novartis Investigative Site
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6163
Country
Australia
Facility Name
Novartis Investigative Site
City
Woodvale
State/Province
Western Australia
ZIP/Postal Code
6026
Country
Australia
Facility Name
Novartis Investigative Site
City
Yokine
State/Province
Western Australia
ZIP/Postal Code
6060
Country
Australia
Facility Name
Novartis Investigative Site
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Auckland
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Christchurch
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Dunedin
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Grafton, Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Tauranga
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
25841237
Citation
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.
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Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

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