A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

Browse trials for

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

Keywords

• COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 614 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

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 dose 1

  QVA149 27.5/12.5 μg capsules

  Drug: QVA149

• Experimental
  QVA149 dose 2

  QVA149 27.5/25 μg capsules

  Drug: QVA149

• Active comparator
  QAB149

  QAB149 75 μg capsules

  Drug: QAB149 · Drug: Placebo

Interventions

• DrugQVA149

  QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI

• DrugQVA149

  QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI

• DrugQAB149

  QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI

• DrugPlacebo

  To mimic QAB149

Primary outcomes

1. Number of Patients With Adverse Events, Serious Adverse Events, and Death

   The overall rate of adverse events reported from initiation through 30 days post last dose.

   Time frame: 56 weeks

Secondary outcomes

1. Time to Premature Discontinuation of Treatment

   methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl

   Time frame: 56 weeks

2. Change From Baseline in Pre-dose Trough FEV1

   Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 \* visit interaction, and visit, treatment \* visit interaction.

   Time frame: Day 29, 57,, 85, 141, 197, 253, 309 and 365

3. Change From Baseline in 1 Hour Post-dose FEV1 Measurements

   Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 \* visit interaction, and visit, treatment \* visit interaction.

   Time frame: Day 1, 29, 57, 85, 141, 197, 253, 309, and 365

4. Change From Baseline in FVC Measurement at All Post-baseline Time Points

   Pulmonary function assessments were performed using centralized spirometry according to international standards.

   Time frame: Day1, 29, 57, 85, 141, 197, 253, 309, and 365

5. Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation

   Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)

   Time frame: 52 weeks

6. Change From Baseline in Mean Total Daily Symptom Scores

   The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.

   Time frame: 52 weeks

7. Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period

   Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.

   Time frame: 52 weeks

Baseline characteristics