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Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
indacaterol/glycopyrrolate
indacaterol
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 (COPD) focused on measuring QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
  2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
  3. Patients who have smoking history of at least 10 pack years.
  4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.

Exclusion Criteria:

  1. Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
  2. Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
  3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
  4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
  5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
  6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
  7. Patients with uncontrolled Type I and Type II diabetes.
  8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
  9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
  10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
  11. Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator site
  • Novartis investigator site
  • Novartis Investigator Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

indacaterol/glycopyrrolate 300/50 μg

indacaterol 600 μg

indacaterol 300 μg

placebo

Arm Description

One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.

Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.

Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Outcomes

Primary Outcome Measures

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.

Secondary Outcome Measures

Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Additional information about adverse events can be found in the Adverse Event Section.

Full Information

First Posted
December 10, 2007
Last Updated
June 28, 2018
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00570778
Brief Title
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (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 evaluate the safety and efficacy of 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
QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
indacaterol/glycopyrrolate 300/50 μg
Arm Type
Experimental
Arm Description
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Arm Title
indacaterol 600 μg
Arm Type
Active Comparator
Arm Description
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Arm Title
indacaterol 300 μg
Arm Type
Active Comparator
Arm Description
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Intervention Type
Drug
Intervention Name(s)
indacaterol/glycopyrrolate
Other Intervention Name(s)
QVA149
Intervention Description
Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
Intervention Type
Drug
Intervention Name(s)
indacaterol
Other Intervention Name(s)
QAB149
Intervention Description
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Primary Outcome Measure Information:
Title
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
Description
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
Time Frame
Baseline, Day 7
Secondary Outcome Measure Information:
Title
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
Description
Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
Time Frame
Day 7
Title
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Description
Additional information about adverse events can be found in the Adverse Event Section.
Time Frame
47 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006. Patients who have smoking history of at least 10 pack years. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70. Exclusion Criteria: Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception. Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening. Patients who have had a respiratory tract infection within 6 weeks prior to screening. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition. Patients with uncontrolled Type I and Type II diabetes. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females). Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures. 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 Investigator Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Novartis Investigator Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Novartis Investigator site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Novartis Investigator Site
City
Antwerpen
Country
Belgium
Facility Name
Novartis Investigator Site
City
Gent
Country
Belgium
Facility Name
Novartis Investigator Site
City
Jambes
Country
Belgium
Facility Name
Novartis Investigator Site
City
Saint Vith
Country
Belgium
Facility Name
Novartis Investigator Site
City
Moncton
Country
Canada
Facility Name
Novartis Investigator Site
City
Montreal
Country
Canada
Facility Name
Novartis Investigator site
City
Toronto
Country
Canada
Facility Name
Novartis Investigator Site
City
Bad Worishofen
Country
Germany
Facility Name
Novartis Investigator Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigator Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigator Site
City
Mainz
Country
Germany
Facility Name
Novartis Investigator Site
City
Rudersdorf
Country
Germany
Facility Name
Novartis Investigator Site
City
Wiesbaden
Country
Germany
Facility Name
Novartis Investigator Site
City
Almelo
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Breda
Country
Netherlands
Facility Name
Novartis Investigator site
City
Eindhoven
Country
Netherlands
Facility Name
Novartis investigator site
City
Heerlen
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Nijmegen
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Veldhoven
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20978028
Citation
van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010 Dec;65(12):1086-91. doi: 10.1136/thx.2010.139113. Epub 2010 Oct 26.
Results Reference
derived

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Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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