Trial Outcomes & Findings for Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients (NCT NCT02125734)
NCT ID: NCT02125734
Last Updated: 2017-04-12
Results Overview
Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
88 participants
Primary outcome timeframe
week 4
Results posted on
2017-04-12
Participant Flow
Participant milestones
| Measure |
Treatment Sequence 1
QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
|
Treatment Sequence 2
Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
|
|---|---|---|
|
Period 1
STARTED
|
40
|
48
|
|
Period 1
COMPLETED
|
40
|
48
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
40
|
48
|
|
Period 2
COMPLETED
|
40
|
47
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1
QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
|
Treatment Sequence 2
Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
|
|---|---|---|
|
Period 2
Adverse Event
|
0
|
1
|
Baseline Characteristics
Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1
n=40 Participants
QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
|
Treatment Sequence 2
n=48 Participants
Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
66.0 Years
STANDARD_DEVIATION 9.31 • n=7 Participants
|
65 Years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 4Population: Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period
Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Outcome measures
| Measure |
QVA149
n=87 Participants
|
Tiotropium
n=88 Participants
|
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation
|
1.676 Liters
95% Confidence Interval 0.5709 • Interval 1.635 to 1.716
|
1.595 Liters
95% Confidence Interval 0.6000 • Interval 1.555 to 1.634
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Three patients were missing data for the patient preference analysis.
Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.
Outcome measures
| Measure |
QVA149
n=85 Participants
|
Tiotropium
n=85 Participants
|
|---|---|---|
|
Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.
|
59 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. One patient with missing data for this analysis.
The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire
Outcome measures
| Measure |
QVA149
n=87 Participants
|
Tiotropium
n=87 Participants
|
|---|---|---|
|
Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.
|
71 Participants
|
16 Participants
|
Adverse Events
QVA149
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Tiotropium
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QVA149
n=88 participants at risk
QVA149
|
Tiotropium
n=88 participants at risk
Tiotropium
|
|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
1/88
|
0.00%
0/88
|
|
Injury, poisoning and procedural complications
Eye injury
|
1.1%
1/88
|
0.00%
0/88
|
Other adverse events
| Measure |
QVA149
n=88 participants at risk
QVA149
|
Tiotropium
n=88 participants at risk
Tiotropium
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
1.1%
1/88
|
0.00%
0/88
|
|
Cardiac disorders
Cardiovascular disorder
|
2.3%
2/88
|
0.00%
0/88
|
|
Cardiac disorders
Palpitations
|
1.1%
1/88
|
1.1%
1/88
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/88
|
0.00%
0/88
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/88
|
0.00%
0/88
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
3/88
|
0.00%
0/88
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
1/88
|
0.00%
0/88
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/88
|
1.1%
1/88
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/88
|
0.00%
0/88
|
|
General disorders
Peripheral swelling
|
0.00%
0/88
|
1.1%
1/88
|
|
Infections and infestations
Bronchitis
|
0.00%
0/88
|
1.1%
1/88
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/88
|
1.1%
1/88
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
3/88
|
2.3%
2/88
|
|
Infections and infestations
Rhinitis
|
0.00%
0/88
|
1.1%
1/88
|
|
Infections and infestations
Sinusitis
|
0.00%
0/88
|
1.1%
1/88
|
|
Infections and infestations
Tooth abscess
|
1.1%
1/88
|
0.00%
0/88
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/88
|
1.1%
1/88
|
|
Injury, poisoning and procedural complications
Wound
|
1.1%
1/88
|
0.00%
0/88
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/88
|
0.00%
0/88
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/88
|
0.00%
0/88
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.1%
1/88
|
0.00%
0/88
|
|
Investigations
Escherichia test positive
|
1.1%
1/88
|
0.00%
0/88
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/88
|
0.00%
0/88
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/88
|
1.1%
1/88
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/88
|
1.1%
1/88
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/88
|
1.1%
1/88
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/88
|
1.1%
1/88
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/88
|
1.1%
1/88
|
|
Nervous system disorders
Dizziness
|
2.3%
2/88
|
0.00%
0/88
|
|
Nervous system disorders
Headache
|
4.5%
4/88
|
2.3%
2/88
|
|
Nervous system disorders
Hypotonia
|
1.1%
1/88
|
0.00%
0/88
|
|
Nervous system disorders
Nerve compression
|
1.1%
1/88
|
0.00%
0/88
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/88
|
1.1%
1/88
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/88
|
0.00%
0/88
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
12/88
|
4.5%
4/88
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.1%
1/88
|
0.00%
0/88
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/88
|
1.1%
1/88
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
1.1%
1/88
|
0.00%
0/88
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/88
|
2.3%
2/88
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
1.1%
1/88
|
0.00%
0/88
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
3/88
|
0.00%
0/88
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/88
|
1.1%
1/88
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/88
|
1.1%
1/88
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.3%
2/88
|
0.00%
0/88
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.1%
1/88
|
0.00%
0/88
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/88
|
1.1%
1/88
|
|
Vascular disorders
Hypertension
|
0.00%
0/88
|
1.1%
1/88
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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