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

March 11, 2011
July 9, 2013
March 2011
March 2012   (final data collection date for primary outcome measure)
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.
To demonstrate the superiority of once-daily QVA149 as compared to twice-daily fluticasone/salmeterol in terms of forced expiratory volume in one second (FEV1) area under the curve for 0-12 hours (AUC0-12h) in patients with moderate to severe COPD. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01315249 on ClinicalTrials.gov Archive Site
  • 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.
  • To evaluate the effect of QVA149 as compared to fluticasone/salmeterol in terms of standardized FEV1 AUC0-12h. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate the effect of QVA149 as compared to fluticasone/salmeterol in terms of safety and tolerability as measured by adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • 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.
  • 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
  • Experimental: QVA149
    Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
    Interventions:
    • Drug: indacaterol and glycopyrronium (QVA149)
    • Drug: Placebo to fluticasone/salmeterol
  • Active Comparator: fluticasone/salmeterol
    Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
    Interventions:
    • Drug: fluticasone/salmeterol
    • Drug: Placebo to indacaterol and glycopyrronium (QVA149)
Vogelmeier CF, Bateman ED, Pallante J, Alagappan VK, D'Andrea P, Chen H, Banerji D. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013 Mar;1(1):51-60. doi: 10.1016/S2213-2600(12)70052-8. Epub 2012 Dec 6. Erratum in: Lancet Respir Med. 2013 Apr;1(2):101.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
523
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Estonia,   Germany,   Hungary,   Korea, Republic of,   Lithuania,   Norway,   Spain
 
NCT01315249
CQVA149A2313, 2010-023621-37
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP