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

Browse trials for

• Lung Diseases 3,303
• Lung Diseases, Obstructive 2,592
• Pulmonary Disease, Chronic Obstructive 4,131

Keywords

• QVA149
• indacaterol
• NVA237
• COPD
• fluticasone/salmeterol

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 523 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Study arms

• Experimental
  QVA149

  Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

  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).

  Drug: fluticasone/salmeterol · Drug: Placebo to indacaterol and glycopyrronium (QVA149)

Interventions

• Drugindacaterol and glycopyrronium (QVA149)

  QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.

• DrugPlacebo to fluticasone/salmeterol

  Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.

• Drugfluticasone/salmeterol

  Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.

• DrugPlacebo to indacaterol and glycopyrronium (QVA149)

  Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily

Primary outcomes

1. Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12

   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.

   Time frame: Week 26

Secondary outcomes

1. Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours

   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.

   Time frame: Week 12

2. Forced Vital Capacity at All-time Points (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.

   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

3. Forced Vital Capacity at All-time Points (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.

   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

4. Focal Score of the Transitional Dyspnea Index (TDI)

   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.

   Time frame: 12 weeks and 26 weeks

5. Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)

   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.

   Time frame: 12 weeks and 26 weeks

6. Mean Change From Baseline in Daily Number of Puffs of Rescue Medication

   Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.

   Time frame: Baseline, 12 weeks and 26 weeks

7. Change From Baseline in Symptom Scores Reported Using the Ediary

   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.

   Time frame: 12 weeks and 26 weeks

8. Inspiratory Capacity (IC) at All-time Points (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.

   Time frame: 12 weeks

9. Inspiratory Capacity (IC) at All-time Points (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.

   Time frame: 26 weeks

10. Number of Participants With Adverse Events

    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.

    Time frame: 26 weeks

Baseline characteristics

Publications

• 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. PubMed 24321804 ↗