Trial Outcomes & Findings for Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study) (NCT NCT02202616)

NCT ID: NCT02202616

Last Updated: 2019-07-02

Results Overview

Primary end points: To evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium 50 mcg) in the management of patients with COPD who have symptoms defined as CAT score \>10 with tiotropium monotherapy; effectiveness will be assessed as the mean change in trough FEV1 from baseline to 16 weeks. and to evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium 50 mcg) in the management of patients with COPD who have symptoms defined as CAT score \>10 while on treatment with FDC of fluticasone propionate/salmeterol; effectiveness will be assessed as the mean change in trough FEV1 from baseline to 16 weeks.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

401 participants

Primary outcome timeframe

16 weeks study

Results posted on

2019-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	QVA149 110/50 QVA149 110/50- Patients diagnosed with chronic obstructive pulmonary disorder (COPD) who are symptomatic (CAT score over 10) and who are treated with Tiotropium (SPIRIVA HANDALER) or Fluticasone propionate/Salmeterol- ADVAIR DISKUS (FDC).
Overall Study STARTED	401
Overall Study Intent to Treat Set (ITT)	338
Overall Study COMPLETED	301
Overall Study NOT COMPLETED	100

Reasons for withdrawal

Reasons for withdrawal
Measure	QVA149 110/50 QVA149 110/50- Patients diagnosed with chronic obstructive pulmonary disorder (COPD) who are symptomatic (CAT score over 10) and who are treated with Tiotropium (SPIRIVA HANDALER) or Fluticasone propionate/Salmeterol- ADVAIR DISKUS (FDC).
Overall Study Screen failed	24
Overall Study Adverse Event	32
Overall Study Protocol deviation	18
Overall Study Patient withdrew consent	12
Overall Study Lost to Follow-up	6
Overall Study Administrative problems	6
Overall Study Abnormal test procedure result	1
Overall Study Unsatisfactory therapeutic effect	1

Baseline Characteristics

Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ULTIBRO BREEZHALER n=338 Participants Patients diagnosed with chronic obstructive pulmonary disorder (COPD) who are symptomatic (CAT score over 10) and who are treated with Tiotropium (SPIRIVA HANDALER) or Fluticasone propionate/Salmeterol- ADVAIR DISKUS (FDC).
Age, Continuous	66.1 Years STANDARD_DEVIATION 9.46 • n=5 Participants
Sex: Female, Male Female	149 Participants n=5 Participants
Sex: Female, Male Male	189 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	330 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks study

Population: Intent to treat set (ITT)- included all patients who received the study treatment and returned for ≥ 1 post baseline visit

Outcome measures

Outcome measures
Measure	QVA149 110/50 After Flu/Sal n=83 Participants QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with FDC of fluticasone propionate and salmeterol	QVA149 110/50 After Tio n=235 Participants QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with tiotropium
Change From Baseline in Trough (Forced Expiratory Volume (FEV1) (Pre-dose FEV1)	0.17 Liter Standard Deviation 0.397	0.18 Liter Standard Deviation 0.321

SECONDARY outcome

Timeframe: Baseline, week 4

Population: Intent to treat set (ITT)- included all patients who received the study treatment and returned for ≥ 1 post baseline visit

Portable spirometers will be provided to investigators and they will use this device for all of their patient measurements of FEV1 during the trial

Outcome measures

Outcome measures
Measure	QVA149 110/50 After Flu/Sal n=79 Participants QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with FDC of fluticasone propionate and salmeterol	QVA149 110/50 After Tio n=224 Participants QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with tiotropium
Change From Baseline in Trough FEV1 (Forced Expiratory Volume) to Week 4	0.12 Liter Standard Deviation 0.308	0.14 Liter Standard Deviation 0.267

SECONDARY outcome

Timeframe: Baseline, Week 4, week 16

Population: Intent to treat set (ITT)- included all patients who received the study treatment and returned for ≥ 1 post baseline visit

A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). BDI/TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. The BDI was assessed at Baseline, whereas the TDI was assessed at Week 4 and Week 16.

Outcome measures

Outcome measures
Measure	QVA149 110/50 After Flu/Sal n=87 Participants QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with FDC of fluticasone propionate and salmeterol	QVA149 110/50 After Tio n=248 Participants QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with tiotropium
Single Point and Change in Baseline Dyspnea Index and Transitional Dyspnea Index (BDI/TDI) BDI week 0	6.5 Score Standard Deviation 2.07	6.8 Score Standard Deviation 2.09
Single Point and Change in Baseline Dyspnea Index and Transitional Dyspnea Index (BDI/TDI) TDI week 4	2.2 Score Standard Deviation 2.72	2.0 Score Standard Deviation 2.38
Single Point and Change in Baseline Dyspnea Index and Transitional Dyspnea Index (BDI/TDI) TDI week 16	2.9 Score Standard Deviation 3.28	2.4 Score Standard Deviation 2.78

SECONDARY outcome

Timeframe: Baseline, week 4, week 16

Population: Intent to treat set (ITT)- included all patients who received the study treatment and returned for ≥ 1 post baseline visit

The CAT is an 8 item questionnaire that assesses the impact of COPD on the patient's functional status. Scores for each of the 8 items are summed to give an overall score (out of 40). The score ranges from 0-40 where higher scores represent worse health status. CAT scores ≥ 10 are associated with significantly impaired health status.

Outcome measures

Outcome measures
Measure	QVA149 110/50 After Flu/Sal n=83 Participants QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with FDC of fluticasone propionate and salmeterol	QVA149 110/50 After Tio n=234 Participants QVA149 110/50 combination of (indacaterol maleate 110 µg and glycopyrronium bromide 50 µg) after patients treated with tiotropium
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Questionnaire (CAT) Week 4	-5.9 Score Standard Deviation 7.55	-4.7 Score Standard Deviation 5.71
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Questionnaire (CAT) Week 16	-8.2 Score Standard Deviation 8.34	-5.9 Score Standard Deviation 6.44

Adverse Events

QVA149 110/50

Serious events: 12 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	QVA149 110/50 n=373 participants at risk QVA149 110/50-Patients diagnosed with chronic obstructive pulmonary disorder (COPD) who are symptomatic (CAT score over 10) and who are treated with Tiotropium (SPIRIVA HANDALER) or Fluticasone propionate/Salmeterol- ADVAIR DISKUS (FDC).
Blood and lymphatic system disorders Anaemia	0.27% 1/373 • From week 0 to week 16
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.27% 1/373 • From week 0 to week 16
Cardiac disorders Cardiac failure	0.27% 1/373 • From week 0 to week 16
Cardiac disorders Cardiac failure congestive	0.27% 1/373 • From week 0 to week 16
Cardiac disorders Sinus tachycardia	0.27% 1/373 • From week 0 to week 16
Gastrointestinal disorders Intestinal ischaemia	0.27% 1/373 • From week 0 to week 16
Infections and infestations Gastroenteritis	0.27% 1/373 • From week 0 to week 16
Infections and infestations Influenza	0.27% 1/373 • From week 0 to week 16
Infections and infestations Pneumonia	1.1% 4/373 • From week 0 to week 16
Injury, poisoning and procedural complications Wound	0.27% 1/373 • From week 0 to week 16
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.27% 1/373 • From week 0 to week 16
Psychiatric disorders Depression	0.27% 1/373 • From week 0 to week 16
Renal and urinary disorders Renal failure	0.27% 1/373 • From week 0 to week 16
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.54% 2/373 • From week 0 to week 16
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.27% 1/373 • From week 0 to week 16
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.27% 1/373 • From week 0 to week 16

Other adverse events

Other adverse events
Measure	QVA149 110/50 n=373 participants at risk QVA149 110/50-Patients diagnosed with chronic obstructive pulmonary disorder (COPD) who are symptomatic (CAT score over 10) and who are treated with Tiotropium (SPIRIVA HANDALER) or Fluticasone propionate/Salmeterol- ADVAIR DISKUS (FDC).
Gastrointestinal disorders Dyspepsia	1.1% 4/373 • From week 0 to week 16
Gastrointestinal disorders Nausea	1.1% 4/373 • From week 0 to week 16
Infections and infestations Bronchitis	2.4% 9/373 • From week 0 to week 16
Infections and infestations Upper respiratory tract infection	2.9% 11/373 • From week 0 to week 16
Nervous system disorders Dizziness	1.1% 4/373 • From week 0 to week 16
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.5% 13/373 • From week 0 to week 16
Respiratory, thoracic and mediastinal disorders Cough	2.7% 10/373 • From week 0 to week 16
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 7/373 • From week 0 to week 16
Vascular disorders Hypertension	1.1% 4/373 • From week 0 to week 16

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER