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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01315249
First received: March 11, 2011
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: indacaterol and glycopyrronium (QVA149)
Drug: Placebo to fluticasone/salmeterol
Drug: fluticasone/salmeterol
Drug: Placebo to indacaterol and glycopyrronium (QVA149)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • Focal Score of the Transitional Dyspnea Index (TDI) [ Time Frame: 12 weeks and 26 weeks ] [ Designated as safety issue: No ]
    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.

  • Total Score of the St. George's Respiratory Questionnaire (SGRQ-C) [ Time Frame: 12 weeks and 26 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Daily Number of Puffs of Rescue Medication [ Time Frame: Baseline, 12 weeks and 26 weeks ] [ Designated as safety issue: No ]
    Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.

  • Change From Baseline in Symptom Scores Reported Using the Ediary [ Time Frame: 12 weeks and 26 weeks ] [ Designated as safety issue: No ]

    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.

  • Inspiratory Capacity (IC) at All-time Points (12 Weeks) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Inspiratory Capacity (IC) at All-time Points (26 Weeks) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Adverse Events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 523
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315249

  Show 92 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01315249     History of Changes
Other Study ID Numbers: CQVA149A2313, 2010-023621-37
Study First Received: March 11, 2011
Results First Received: February 28, 2013
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Hungary: National Institute of Pharmacy
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Germany: Paul-Ehrlich-Institut
Korea: Food and Drug Administration
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Institute of Public Health
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
QVA149
indacaterol
NVA237
COPD
fluticasone/salmeterol

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Glycopyrrolate
Salmeterol
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents

ClinicalTrials.gov processed this record on April 16, 2014