Trial Outcomes & Findings for Drug Use Survey of RESPIMAT in Patients With COPD (NCT NCT01145053)
NCT ID: NCT01145053
Last Updated: 2014-03-27
Results Overview
The number of patient with any AEs, patients with drug-related AEs
COMPLETED
361 participants
Week 52
2014-03-27
Participant Flow
A total of 361 patients were enrolled. Of these patients, the CRF of 4 patients were uncollected by reason of institution, and the 16 patients who did not visit after enrollment. Then, total 341 patients were observed in the survey.
Participant milestones
| Measure |
Spiriva Respimat
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Overall Study
STARTED
|
341
|
|
Overall Study
COMPLETED
|
248
|
|
Overall Study
NOT COMPLETED
|
93
|
Reasons for withdrawal
| Measure |
Spiriva Respimat
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
Lost to Follow-up
|
28
|
|
Overall Study
Withdrawal by Subject
|
25
|
|
Overall Study
Other
|
18
|
Baseline Characteristics
Drug Use Survey of RESPIMAT in Patients With COPD
Baseline characteristics by cohort
| Measure |
Spiriva Respimat
n=341 Participants
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
294 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: The all treated patients
The number of patient with any AEs, patients with drug-related AEs
Outcome measures
| Measure |
Spiriva Respimat
n=341 Participants
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Incidence of Adverse Events (AEs)
patient with any AEs
|
53 Patients
|
|
Incidence of Adverse Events (AEs)
patients with drug-related AEs
|
16 Patients
|
SECONDARY outcome
Timeframe: Week 52Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set.
Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.
Outcome measures
| Measure |
Spiriva Respimat
n=316 Participants
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Effectiveness
Improved
|
191 Patients
|
|
Effectiveness
No change
|
122 Patients
|
|
Effectiveness
Aggravated
|
3 Patients
|
SECONDARY outcome
Timeframe: Week 0 and Week 52Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 105 patients measured FEV1 .
FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.
Outcome measures
| Measure |
Spiriva Respimat
n=105 Participants
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Forced Expiratory Volume in One Second (FEV1)
Week 0
|
1.39 L
Standard Deviation 0.66
|
|
Forced Expiratory Volume in One Second (FEV1)
Week 52
|
1.46 L
Standard Deviation 0.66
|
|
Forced Expiratory Volume in One Second (FEV1)
Change from Week 0 to Week 52
|
0.06 L
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Week 0 and Week 52Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Cough Frequency .
Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.
Outcome measures
| Measure |
Spiriva Respimat
n=309 Participants
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Cough Frequency
Week 0
|
2.10 Units on a scale
Standard Deviation 0.69
|
|
Cough Frequency
Week 52
|
1.62 Units on a scale
Standard Deviation 0.59
|
|
Cough Frequency
Change from Week 0 to Week 52
|
-0.47 Units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Week 0 and Week 52Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Amount of Sputum.
Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.
Outcome measures
| Measure |
Spiriva Respimat
n=309 Participants
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Amount of Sputum
Week 52
|
1.63 Units on a scale
Standard Deviation 0.61
|
|
Amount of Sputum
Change from Week 0 to Week 52
|
-0.42 Units on a scale
Standard Deviation 0.63
|
|
Amount of Sputum
Week 0
|
2.05 Units on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Week 0 and Week 52Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Shortness of Breath.
Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.
Outcome measures
| Measure |
Spiriva Respimat
n=309 Participants
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Shortness of Breath
Week 0
|
3.28 Units on a scale
Standard Deviation 1.29
|
|
Shortness of Breath
Week 52
|
2.69 Units on a scale
Standard Deviation 1.34
|
|
Shortness of Breath
Change from Week 0 to Week 52
|
-0.59 Units on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Week 0 and Week 52Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 308 patients recorded the Nocturnal Sleep.
Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.
Outcome measures
| Measure |
Spiriva Respimat
n=308 Participants
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Nocturnal Sleep
Week 0
|
1.55 Units on a scale
Standard Deviation 0.84
|
|
Nocturnal Sleep
Week 52
|
1.25 Units on a scale
Standard Deviation 0.60
|
|
Nocturnal Sleep
Change from Week 0 to Week 52
|
-0.31 Units on a scale
Standard Deviation 0.58
|
Adverse Events
Spiriva Respimat
Serious adverse events
| Measure |
Spiriva Respimat
n=341 participants at risk
Spiriva 2.5 mcg Respimat 60 puffs
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
0.29%
1/341 • 52 weeks
|
|
Cardiac disorders
Cor pulmonale
|
0.29%
1/341 • 52 weeks
|
|
Eye disorders
Cataract
|
0.29%
1/341 • 52 weeks
|
|
Eye disorders
Maculopathy
|
0.29%
1/341 • 52 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.29%
1/341 • 52 weeks
|
|
General disorders
Death
|
0.29%
1/341 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
1.2%
4/341 • 52 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.88%
3/341 • 52 weeks
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.29%
1/341 • 52 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.29%
1/341 • 52 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.59%
2/341 • 52 weeks
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.29%
1/341 • 52 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.29%
1/341 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.29%
1/341 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to chest wall
|
0.29%
1/341 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.88%
3/341 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.29%
1/341 • 52 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.29%
1/341 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.29%
1/341 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
4/341 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.29%
1/341 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.29%
1/341 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.29%
1/341 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.59%
2/341 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.88%
3/341 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.88%
3/341 • 52 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place