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A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (SHINE)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

indacaterol and glycopyrronium (QVA149)

glycopyrronium (NVA237)

indacaterol (QAB149)

tiotropium

placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring QVA149, COPD, combination bronchodilator, indacaterol, glycopyrronium bromide

Eligibility Criteria

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

Inclusion Criteria:

Male or female adults aged ≥40 yrs
Smoking history of at least 10 pack years
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular co-morbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for inhaled anticholinergic agents and β2 agonists
Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

indacaterol and glycopyrronium (QVA149)

glycopyrronium (NVA237)

indacaterol (QAB149)

tiotropium

Placebo

Arm Description

QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Matching placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment

Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Secondary Outcome Measures

Transitional Dyspnea Index (TDI) Focal Score at Week 26

A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 26

SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. A mixed model was used with treatment as a fixed effect with Baseline SGRQ and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks

The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient. Rescue medication data recorded during the 14 day run-in was used to calculate the baseline. A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo

Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium

Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26

A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). BDI/TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators as covariates and included baseline smoking status, baseline inhaled corticosteroids and region as fixed effects with center nested within region as a random effect.

Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment

A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing) at Week 12 and Week 26. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. The BDI (baseline) was measured at Day 1. The TDI captures changes from baseline. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9.

St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment

Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment

Percentage of Nights With "No Night Time Awakenings" Over 26 Weeks

A day with no night time awakenings is defined from the diary data as any day where the patient did not wake up due to COPD symptoms. The percentage of nights is calculated by the number of days with no nighttime awakenings/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Percentage of Days With "No Daytime Symptoms" Over 26 Weeks

A day with no day time symptoms is defined from the diary data as any day where the patient recorded no coughing, no wheezing, no sputum production and no breathlessness during the previous 12 hours (approximately 8AM to 8PM). The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Percentage of "Days Able to Perform Usual Daily Activities" Over 26 Weeks

Patients answered the question "Did your respiratory symptoms stop you performing your usual activities today?-Not at all in their daily diary. The percentage of days is calculated by the number of days patient is able to perform daily activities/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of Days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26

Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks

The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs in the morning and evening were calculated and divided by the number of days with data to determine the mean daily number of daytime and nighttime puffs. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline (BL) ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Percentage of "Days With no Rescue Medication Use" Over 26 Weeks

A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12, 23 hours 15 minutes and 23 hours 45 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.

24 Hour Holter Monitoring in a Subset of Patients

24-hourly mean heart rate was performed using a Holter Monitor at Weeks 12 and 26 in a subgroup of patients. Mixed model: heart rate = treatment + baseline heart rate + baseline smoking status + baseline ICS use + region + center (region) + error. Center was included as a random effect nested within region. The 24-hourly mean heart rate is the mean heart rate over the 24 hour period, derived using hourly mean heart rate beats per minute.

Rate of Moderate or Severe COPD Exacerbation

Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period

Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization

Full Information

NCT ID

NCT01202188

First Posted

September 13, 2010

Last Updated

August 26, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01202188

Brief Title

A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Acronym

SHINE

Official Title

A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

QVA149, COPD, combination bronchodilator, indacaterol, glycopyrronium bromide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

indacaterol and glycopyrronium (QVA149)

Arm Type

Experimental

Arm Description

Arm Title

glycopyrronium (NVA237)

Arm Type

Active Comparator

Arm Description

Arm Title

indacaterol (QAB149)

Arm Type

Active Comparator

Arm Description

Arm Title

tiotropium

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

indacaterol and glycopyrronium (QVA149)

Intervention Description

Capsules for inhalation delivered via SDDPI.

Intervention Type

Drug

Intervention Name(s)

glycopyrronium (NVA237)

Intervention Description

Capsules for inhalation delivered via SDDPI.

Intervention Type

Drug

Intervention Name(s)

indacaterol (QAB149)

Intervention Description

Capsules for inhalation delivered via SDDPI.

Intervention Type

Drug

Intervention Name(s)

tiotropium

Intervention Description

Capsules for inhalation delivered via HandiHaler® device.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo to match capsules for inhalation delivered via SDDPI.

Primary Outcome Measure Information:

Title

Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment

Description

Time Frame

23 hours 15 minutes and 23 hour 45 minute post-dose Week 26

Secondary Outcome Measure Information:

Title

Transitional Dyspnea Index (TDI) Focal Score at Week 26

Description

Time Frame

Week 26

Title

St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 26

Description

Time Frame

26 weeks

Title

Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks

Description

Time Frame

Baseline, Week 26

Title

Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo

Description

Time Frame

23 hours 15 minutes and 23 hour 45 minute post-dose Week 26

Title

Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium

Description

Time Frame

23 hours 15 minutes and 23 hour 45 minute post-dose Week 26

Title

Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26

Description

Time Frame

Baseline, Week 12, Week 26

Title

Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment

Description

Time Frame

Baseline, Week 26

Title

St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment

Description

Time Frame

Week 12, Week 26

Title

Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment

Description

Time Frame

Baseline, Week 26

Title

Percentage of Nights With "No Night Time Awakenings" Over 26 Weeks

Description

Time Frame

26 Weeks

Title

Percentage of Days With "No Daytime Symptoms" Over 26 Weeks

Description

Time Frame

26 Weeks

Title

Percentage of "Days Able to Perform Usual Daily Activities" Over 26 Weeks

Description

Time Frame

26 Weeks

Title

Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26

Description

Time Frame

Baseline, Week 12, Week 26

Title

Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks

Description

Time Frame

Baseline, Week 26

Title

Percentage of "Days With no Rescue Medication Use" Over 26 Weeks

Description

Time Frame

26 Weeks

Title

Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26

Description

Time Frame

From 5 minutes to 4 hours post-dose Day 1 and Week 26

Title

Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26

Description

Time Frame

From 5 minutes to 12 hours post-dose Day 1 and Week 26

Title

Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26

Description

Time Frame

From 5 minutes to 23 hours 45 minutes post-dose Week 26

Title

24 Hour Holter Monitoring in a Subset of Patients

Description

Time Frame

Week 12, Week 26

Title

Rate of Moderate or Severe COPD Exacerbation

Description

Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years

Time Frame

26 Weeks

Title

Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period

Time Frame

26 Weeks

Title

Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization

Time Frame

26 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female adults aged ≥40 yrs Smoking history of at least 10 pack years Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70% Exclusion Criteria: Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 Patients with concomitant pulmonary disease Patients with a history of asthma Any patient with lung cancer or a history of lung cancer Patients with a history of certain cardiovascular co-morbid conditions Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency Patients in the active phase of a supervised pulmonary rehabilitation program Patients contraindicated for inhaled anticholinergic agents and β2 agonists 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 Chair

Facility Information:

Facility Name

Novartis Investigative Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novartis Investigative Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

Novartis Investigative Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33707

Country

United States

Facility Name

Novartis Investigative Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

Facility Name

Novartis Investigative Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Novartis Investigative Site

City

St. Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

Facility Name

Novartis Investigative Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Novartis Investigative Site

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37601

Country

United States

Facility Name

Novartis Investigative Site

City

Daw Park

Country

Australia

Facility Name

Novartis Investigative Site

City

Glebe

Country

Australia

Facility Name

Novartis Investigative Site

City

Kogarah

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

Country

Australia

Facility Name

Novartis Investigative site

City

New lambton

Country

Australia

Facility Name

Novartis Investigative Site

City

Pleven

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Russe

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Stara Zagora

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

Ontario

Country

Canada

Facility Name

Novartis Investigative Site

City

Courtice

State/Province

Ontario

Country

Canada

Facility Name

Novartis Investigative Site

City

Mississuaga

State/Province

Ontario

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Novartis Investigative Site

City

Beuvry

Country

France

Facility Name

Novartis Investigative Site

City

Bourges

Country

France

Facility Name

Novartis Investigative Site

City

Ferolles-Attily

Country

France

Facility Name

Novartis Investigative Site

City

Rennes

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

Country

Germany

Facility Name

Novartis Investigative Site

City

Geesthacht

Country

Germany

Facility Name

Novartis Investigative Site

City

Hanover

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

Country

Germany

Facility Name

Novartis Investigative Site

City

Minden

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

Country

Germany

Facility Name

Novartis Investigative Site

City

Guatemala City

Country

Guatemala

Facility Name

Novartis INvestigative Site

City

Balassagyarmat

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyor

Country

Hungary

Facility Name

Novartis Investigative Site

City

Komarom

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyhaza

Country

Hungary

Facility Name

Novartis Investigative Site

City

Tatabanya

Country

Hungary

Facility Name

Novartis Investigative Site

City

Asahikawa

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiba

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka

Country

Japan

Facility Name

Novartis Investigative Site

City

Hachioji

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamakita

Country

Japan

Facility Name

Novartis Investigative Site

City

Himeji

Country

Japan

Facility Name

Novartis Investigative Site

City

Hiroshima

Country

Japan

Facility Name

Novartis Investigative Site

City

Hitachi

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi

Country

Japan

Facility Name

Novartis Inverstigative Site

City

Iwata

Country

Japan

Facility Name

Novartis Investigative Site

City

Kamogawa

Country

Japan

Facility Name

Novartis Investigative Site

City

Kishiwada

Country

Japan

Facility Name

Novartis Investigative Site

City

Kiyose

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurashiki

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsusaka

Country

Japan

Facility Name

Novartis Investigative Site

City

Matumoto

Country

Japan

Facility Name

Novartis Investigative Site

City

Minato-ku

Country

Japan

Facility Name

Novartis Investigative Site

City

Moriya

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagaoka

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagoya

Country

Japan

Facility Name

Novartis Investigative Site

City

Niigata

Country

Japan

Facility Name

Novartis Investigative Site

City

Obihiro

Country

Japan

Facility Name

Novartis Investigative Site

City

Sakaide

Country

Japan

Facility Name

Novartis Investigative Site

City

Sakai

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo

Country

Japan

Facility Name

Novartis Investigative Site

City

Tachikawa

Country

Japan

Facility Name

Novartis Investigative Site

City

Takatsuki

Country

Japan

Facility Name

Novartis Investigative Site

City

Tsu

Country

Japan

Facility Name

Novartis Investigative Site

City

Yabu

Country

Japan

Facility Name

Novartis Investigative Site

City

Yanagawa

Country

Japan

Facility Name

Novartis Investigative Site

City

Yatsushiro

Country

Japan

Facility Name

Novartis Investigative Site

City

Yonezawa

Country

Japan

Facility Name

Novartis Investigative Site

City

Bulacan

Country

Philippines

Facility Name

Novartis Investigative Site

City

Las Pinas City

Country

Philippines

Facility Name

Novartis Investigative Site

City

Manila

Country

Philippines

Facility Name

Novartis Investigative Site

City

Pasay City

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

Country

Philippines

Facility Name

Novartis Investigative Site

City

Krakow

Country

Poland

Facility Name

Novartis Investigative Site

City

Proszowice

Country

Poland

Facility Name

Novartis Investigative Site

City

Tarnov

Country

Poland

Facility Name

Novartis Investigative Site

City

Warsaw

Country

Poland

Facility Name

Novartis Investigative Site

City

Barnaul

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhny Novogorod

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Samara

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ufa

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bardejov

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bojnice

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Humenne

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Hradok

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Partizanske

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Prievidza

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Spisska Nova Ves

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trstena

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zvolen

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Cape Town

Country

South Africa

Facility Name

Novartis Investigative Site

City

Durban

Country

South Africa

Facility Name

Novartis Investigative Site

City

Johannesburg

Country

South Africa

Facility Name

Novartis Investigative Site

City

Lyttleton

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

Country

South Africa

Facility Name

Novartis Investigative Site

City

Alcira

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

Country

Spain

Facility Name

Novartis Investigative Site

City

Canet de Mar

Country

Spain

Facility Name

Novartis Investigative Site

City

Centelles

Country

Spain

Facility Name

Novartis Investigative Site

City

Ferrol

Country

Spain

Facility Name

Novartis Investigative Site

City

Fuenlabrada

Country

Spain

Facility Name

Novartis Investigative Site

City

Les Borges del Camp

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

Country

Spain

Facility Name

Novartis Investigative Site

City

Mataro

Country

Spain

Facility Name

Novartis Investigative Site

City

Merida

Country

Spain

Facility Name

Novartis Investigative Site

City

Mostoles

Country

Spain

Facility Name

Novartis Investigative Site

City

Motril

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

Country

Spain

Facility Name

Novartis Investigative Site

City

Ponferrada

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

Country

Spain

Facility Name

Novartis Investigative Site

City

Salt

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

Country

Spain

Facility Name

Novartis Investigative Site

City

Vic

Country

Spain

Facility Name

Novartis Investigative Site

City

Basel

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lugano

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Munchenstein

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Neuchatel

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zurich

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Chai-Yi

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Adana

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

Country

Turkey

Facility Name

Novartis Investigative Site

City

Bolu

Country

Turkey

Facility Name

Novartis Investigative Site

City

Bursa

Country

Turkey

Facility Name

Novartis Investigative Site

City

Canakkale

Country

Turkey

Facility Name

Novartis Investigative Site

City

Denizli

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kocaeli

Country

Turkey

Facility Name

Novartis Investigative Site

City

Manisa

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

Country

Turkey

Facility Name

Novartis Investigative Site

City

Bath

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Blackpool

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cambs

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chelmsford

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chesterfield

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Herts

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Isle of Wight

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25609942

Citation

Kulich K, Keininger DL, Tiplady B, Banerji D. Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study. Int J Chron Obstruct Pulmon Dis. 2015 Jan 7;10:79-94. doi: 10.2147/COPD.S73092. eCollection 2015.

Results Reference

derived

Learn more about this trial

A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

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A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (SHINE)

Chronic Obstructive Pulmonary Disease (COPD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial