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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All eligible patients were randomized to one of the 2 arms in a 1:1 ratio for 26 weeks of treatment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 523 patients were randomized. A total of 522 patients (99.8%) were included in the Full analysis Set (FAS) and Safety set. One patient was excluded who was randomized in error and did not receive study medication.

Reporting Groups

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

Participant Flow:   Overall Study

	QVA149	Fluticasone/Salmeterol
STARTED	259	264
COMPLETED	215	217
NOT COMPLETED	44	47
Adverse Event	22	26
Withdrawal by Subject	11	10
Protocol Violation	8	5
Abnormal test results	1	2
Administrative problems	1	0
inability to use device	1	0
Lack of Efficacy	0	1
Lost to Follow-up	0	2
Death	0	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
QVA149	Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol	Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Total	Total of all reporting groups

Baseline Measures

	QVA149	Fluticasone/Salmeterol	Total
Overall Participants Analyzed  [Units: Participants]	258	264	522
Age  [Units: Years] Mean (Standard Deviation)	63.2  (8.16)	63.4  (7.71)	63.3  (7.93)
Gender  [Units: Participants]
Female	77	75	152
Male	181	189	370

1.  Primary:

Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12   [ Time Frame: Week 26 ]

2.  Secondary:

Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours   [ Time Frame: Week 12 ]

3.  Secondary:

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 ]

4.  Secondary:

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 ]

5.  Secondary:

Focal Score of the Transitional Dyspnea Index (TDI)   [ Time Frame: 12 weeks and 26 weeks ]

6.  Secondary:

Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)   [ Time Frame: 12 weeks and 26 weeks ]

7.  Secondary:

Mean Change From Baseline in Daily Number of Puffs of Rescue Medication   [ Time Frame: Baseline, 12 weeks and 26 weeks ]

8.  Secondary:

Change From Baseline in Symptom Scores Reported Using the Ediary   [ Time Frame: 12 weeks and 26 weeks ]

9.  Secondary:

Inspiratory Capacity (IC) at All-time Points (12 Weeks)   [ Time Frame: 12 weeks ]

10.  Secondary:

Inspiratory Capacity (IC) at All-time Points (26 Weeks)   [ Time Frame: 26 weeks ]

11.  Secondary:

Number of Participants With Adverse Events   [ Time Frame: 26 weeks ]