Trial Outcomes & Findings for Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD (NCT NCT02055352)
NCT ID: NCT02055352
Last Updated: 2017-04-18
Results Overview
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
COMPLETED
PHASE4
222 participants
Baseline and week 12
2017-04-18
Participant Flow
Participant milestones
| Measure |
Budesonide/Indacaterol
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
|
Fluticasone / Salmeterol
Fixed combination of fluticasone and salmeterol
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
113
|
|
Overall Study
Per-Protocol Set (PPS)
|
108
|
111
|
|
Overall Study
COMPLETED
|
103
|
96
|
|
Overall Study
NOT COMPLETED
|
6
|
17
|
Reasons for withdrawal
| Measure |
Budesonide/Indacaterol
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
|
Fluticasone / Salmeterol
Fixed combination of fluticasone and salmeterol
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Non-eligible
|
0
|
1
|
|
Overall Study
Poor compliance
|
1
|
1
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Patient decision
|
1
|
1
|
|
Overall Study
Use of prohibited treatment
|
0
|
3
|
|
Overall Study
AE, study drug would be detrimental
|
1
|
3
|
|
Overall Study
Withdrawal of informed consent
|
1
|
0
|
|
Overall Study
Reason unknown
|
1
|
5
|
Baseline Characteristics
Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD
Baseline characteristics by cohort
| Measure |
Budesonide/Indacaterol
n=109 Participants
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
|
Fluticasone / Salmeterol
n=113 Participants
Fixed combination of fluticasone and salmeterol
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
67.3 Years
STANDARD_DEVIATION 8.45 • n=7 Participants
|
67.2 Years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Outcome measures
| Measure |
Budesonide/Indacaterol
n=108 Participants
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
|
Fluticasone / Salmeterol
n=111 Participants
Fixed combination of fluticasone and salmeterol
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (Non-inferiority Analysis).
|
0.080 Liters
Standard Error 0.027
|
0.019 Liters
Standard Error 0.028
|
SECONDARY outcome
Timeframe: Baseline, week 12 and week 24Population: Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to
Modified Medical Research Council scale (mMRC) questionnaire will be completed by participants. 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing
Outcome measures
| Measure |
Budesonide/Indacaterol
n=108 Participants
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
|
Fluticasone / Salmeterol
n=111 Participants
Fixed combination of fluticasone and salmeterol
|
|---|---|---|
|
Change in Health Status - mMRC
Week 12
|
1.452 Score on a scale
Standard Error 0.111
|
1.623 Score on a scale
Standard Error 0.113
|
|
Change in Health Status - mMRC
Week 24
|
1.315 Score on a scale
Standard Error 0.112
|
1.414 Score on a scale
Standard Error 0.115
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients that were not discontinued before Visit 3 (day 28±3).
A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.
Outcome measures
| Measure |
Budesonide/Indacaterol
n=105 Participants
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
|
Fluticasone / Salmeterol
n=105 Participants
Fixed combination of fluticasone and salmeterol
|
|---|---|---|
|
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 24 Week Treatment
|
10.5 Puffs
Standard Deviation 9.53
|
12.9 Puffs
Standard Deviation 12.34
|
SECONDARY outcome
Timeframe: Baseline and week 24Population: Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Outcome measures
| Measure |
Budesonide/Indacaterol
n=108 Participants
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
|
Fluticasone / Salmeterol
n=111 Participants
Fixed combination of fluticasone and salmeterol
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 24 (Analysis of Superiority)
|
0.063 Liters
Standard Error 0.033
|
0.020 Liters
Standard Error 0.034
|
SECONDARY outcome
Timeframe: Baseline, week 12 and week 24Population: Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to
St George's Respiratory Questionnaire short version questionnaire will be completed by participants. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Outcome measures
| Measure |
Budesonide/Indacaterol
n=108 Participants
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
|
Fluticasone / Salmeterol
n=111 Participants
Fixed combination of fluticasone and salmeterol
|
|---|---|---|
|
Change in Health Status - SGRQ-C
Week 12
|
-8.703 Score on a scale
Standard Error 2.006
|
-2.334 Score on a scale
Standard Error 2.053
|
|
Change in Health Status - SGRQ-C
Week 24
|
-7.787 Score on a scale
Standard Error 2.308
|
-2.523 Score on a scale
Standard Error 2.384
|
Adverse Events
Budesonide / Indacaterol (A)
Fluticasone / Salmeterol (B)
Serious adverse events
| Measure |
Budesonide / Indacaterol (A)
n=109 participants at risk
Budesonide / Indacaterol (A)
|
Fluticasone / Salmeterol (B)
n=113 participants at risk
Fluticasone / Salmeterol (B)
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/109
|
0.88%
1/113
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/109
|
0.88%
1/113
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/109
|
0.88%
1/113
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/109
|
0.88%
1/113
|
|
Infections and infestations
Cellulitis
|
0.00%
0/109
|
0.88%
1/113
|
|
Infections and infestations
Pneumonia
|
2.8%
3/109
|
0.88%
1/113
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/109
|
0.88%
1/113
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.92%
1/109
|
0.00%
0/113
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/109
|
0.88%
1/113
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/109
|
0.88%
1/113
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.5%
6/109
|
1.8%
2/113
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.92%
1/109
|
0.00%
0/113
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.92%
1/109
|
0.00%
0/113
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/109
|
0.88%
1/113
|
|
Vascular disorders
Vascular insufficiency
|
0.00%
0/109
|
0.88%
1/113
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/109
|
0.88%
1/113
|
Other adverse events
| Measure |
Budesonide / Indacaterol (A)
n=109 participants at risk
Budesonide / Indacaterol (A)
|
Fluticasone / Salmeterol (B)
n=113 participants at risk
Fluticasone / Salmeterol (B)
|
|---|---|---|
|
Infections and infestations
Influenza
|
5.5%
6/109
|
8.8%
10/113
|
|
Infections and infestations
Nasopharyngitis
|
10.1%
11/109
|
8.8%
10/113
|
|
Infections and infestations
Urinary tract infection
|
2.8%
3/109
|
6.2%
7/113
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.92%
1/109
|
6.2%
7/113
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.92%
1/109
|
5.3%
6/113
|
|
Nervous system disorders
Headache
|
0.92%
1/109
|
8.0%
9/113
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.8%
3/109
|
7.1%
8/113
|
Additional Information
Study Director
Novartis Pharmaceuticals
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