QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)

July 9, 2013 updated by: Novartis Pharmaceuticals

A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

523

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1000
        • Novartis Investigative Site
      • Hasselt, Belgium, 3500
        • Novartis Investigative Site
      • Jambes, Belgium, 5100
        • Novartis Investigative Site
      • Jette, Belgium, 1090
        • Novartis Investigative Site
      • Luxembourg, Belgium, 1210
        • Novartis Investigative Site
      • Malmedy, Belgium, 4960
        • Novartis Investigative Site
  • Czech Republic
      • Cvikov, Czech Republic, 471 54
        • Novartis Investigative Site
      • JIndrichuv Hradec, Czech Republic, 377 01
        • Novartis Investigative Site
      • Melnik, Czech Republic, 276 01
        • Novartis Investigative Site
      • Pardubice, Czech Republic, 530 09
        • Novartis Investigative Site
      • Prague 3, Czech Republic, 130 00
        • Novartis Investigative Site
      • Praha 10, Czech Republic, 108 00
        • Novartis Investigative Site
      • Teplice, Czech Republic, 415 01
        • Novartis Investigative Site
    • CZE
      • Kyjov, CZE, Czech Republic, 697 70
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 13419
        • Novartis Investigative Site
      • Tartu, Estonia, 51014
        • Novartis Investigative Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Novartis Investigative Site
      • Bad Woerishofen, Germany, 86825
        • Novartis Investigative Site
      • Bamberg, Germany, 96049
        • Novartis Investigative Site
      • Berlin, Germany, 13086
        • Novartis Investigative Site
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Berlin, Germany, 14050
        • Novartis Investigative Site
      • Berlin, Germany, D-12165
        • Novartis Investigative Site
      • Berlin, Germany, 13581
        • Novartis Investigative Site
      • Berlin, Germany, 13057
        • Novartis Investigative Site
      • Berlin, Germany, 13507
        • Novartis Investigative Site
      • Bielefeld, Germany, 33617
        • Novartis Investigative Site
      • Bochum, Germany, 44787
        • Novartis Investigative Site
      • Bonn, Germany, 53123
        • Novartis Investigative Site
      • Borstel, Germany, 23845
        • Novartis Investigative Site
      • Dueren, Germany, 52349
        • Novartis Investigative Site
      • Eschwege, Germany, 37269
        • Novartis Investigative Site
      • Frankfurt, Germany, 60596
        • Novartis Investigative Site
      • Freudenberg, Germany, 57258
        • Novartis Investigative Site
      • Fulda, Germany, 36039
        • Novartis Investigative Site
      • Fürstenwalde/Spree, Germany, 15517
        • Novartis Investigative Site
      • Gelsenkirchen, Germany, 45879
        • Novartis Investigative Site
      • Gummersbach, Germany, 51643
        • Novartis Investigative Site
      • Göttingen, Germany, 37075
        • Novartis Investigative Site
      • Güstrow, Germany, 18273
        • Novartis Investigative Site
      • Hagen, Germany, 59065
        • Novartis Investigative Site
      • Hamburg, Germany, 20354
        • Novartis Investigative Site
      • Hamburg, Germany, 20357
        • Novartis Investigative Site
      • Hamburg, Germany, 20253
        • Novartis Investigative Site
      • Hannover, Germany, 30167
        • Novartis Investigative Site
      • Hildesheim, Germany, 31134
        • Novartis Investigative Site
      • Leipzig, Germany, 04207
        • Novartis Investigative Site
      • Lübeck, Germany, 23558
        • Novartis Investigative Site
      • Muenchen, Germany, 80539
        • Novartis Investigative Site
      • Oschersleben, Germany, 39387
        • Novartis Investigative Site
      • Ratingen, Germany, 40878
        • Novartis Investigative Site
      • Rheine, Germany, 48431
        • Novartis Investigative Site
      • Saarbrücken, Germany, 66111
        • Novartis Investigative Site
      • Schwerte, Germany, 58239
        • Novartis Investigative Site
      • Solingen, Germany, 42651
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Novartis Investigative Site
      • Wissen, Germany, 57537
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1191
        • Novartis Investigative Site
      • Cegled, Hungary, 2700
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Novartis Investigative Site
      • Eger, Hungary, 3300
        • Novartis Investigative Site
      • Godollo, Hungary, 2100
        • Novartis Investigative Site
      • Mosonmagyarovar, Hungary, 9200
        • Novartis Investigative Site
      • Szarvas, Hungary, 5540
        • Novartis Investigative Site
      • Szeged, Hungary, 6770
        • Novartis Investigative Site
      • Torokbalint, Hungary, 2045
        • Novartis Investigative Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-717
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 130-709
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 130-702
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 152-703
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 100-032
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 143-729
        • Novartis Investigative Site
    • Gangwon
      • Wonju, Gangwon, Korea, Republic of, 220-701
        • Novartis Investigative Site
  • Lithuania
      • Alytus, Lithuania, LT-62114
        • Novartis Investigative Site
      • Kaunas, Lithuania, 44320
        • Novartis Investigative Site
      • Klaipeda, Lithuania, 92288
        • Novartis Investigative Site
      • Klaipeda, Lithuania, LT-92231
        • Novartis Investigative Site
      • Utena, Lithuania, LT-28151
        • Novartis Investigative Site
      • Vilnius, Lithuania, 06001
        • Novartis Investigative Site
  • Norway
      • Kongsvinger, Norway, 2212
        • Novartis Investigative Site
      • Skedsmokorset, Norway, 2020
        • Novartis Investigative Site
      • Stavanger, Norway, 4005
        • Novartis Investigative Site
      • Trondheim, Norway, 7006
        • Novartis Investigative Site
      • Ålesund, Norway, 6017
        • Novartis Investigative Site
  • Spain
      • Alicante, Spain, 03114
        • Novartis Investigative Site
      • Valladolid, Spain, 47011
        • Novartis Investigative Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08025
        • Novartis Investigative Site
      • Sabadell, Cataluña, Spain, 08208
        • Novartis Investigative Site
      • Sant Boi de Llobregat, Cataluña, Spain, 08830
        • Novartis Investigative Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Smoking history of at least 10 pack years
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
  • Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%

Exclusion Criteria:

  • Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
  • Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
  • 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 (within last 5 years)
  • Patients with a history of certain cardiovascular co-morbid conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QVA149
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Drug: indacaterol and glycopyrronium (QVA149)
QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.
Drug: Placebo to fluticasone/salmeterol
Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.
Active Comparator: fluticasone/salmeterol
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Drug: fluticasone/salmeterol
Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.
Drug: Placebo to indacaterol and glycopyrronium (QVA149)
Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12
Time Frame: Week 26
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.
Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours
Time Frame: Week 12
Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.
Week 12
Forced Vital Capacity at All-time Points (Week 12)
Time Frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model.
-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12
Forced Vital Capacity at All-time Points (Week 26)
Time Frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model.
-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26
Focal Score of the Transitional Dyspnea Index (TDI)
Time Frame: 12 weeks and 26 weeks
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.
12 weeks and 26 weeks
Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)
Time Frame: 12 weeks and 26 weeks
The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
12 weeks and 26 weeks
Mean Change From Baseline in Daily Number of Puffs of Rescue Medication
Time Frame: Baseline, 12 weeks and 26 weeks
Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
Baseline, 12 weeks and 26 weeks
Change From Baseline in Symptom Scores Reported Using the Ediary
Time Frame: 12 weeks and 26 weeks

Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.

Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.

0 is the minimum score = "none" or "No symptoms" or "never" or "No"

  1. = mild, a little
  2. = moderate
  3. = severe For the scale range provided, high values represent a worse outcome.
12 weeks and 26 weeks
Inspiratory Capacity (IC) at All-time Points (12 Weeks)
Time Frame: 12 weeks
After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
12 weeks
Inspiratory Capacity (IC) at All-time Points (26 Weeks)
Time Frame: 26 weeks
After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
26 weeks
Number of Participants With Adverse Events
Time Frame: 26 weeks
The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQVA149A2313
  • 2010-023621-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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