Trial Outcomes & Findings for Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region (NCT NCT01006135)
NCT ID: NCT01006135
Last Updated: 2014-04-10
Results Overview
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
COMPLETED
4852 participants
Baseline and 6 months
2014-04-10
Participant Flow
Whilst 4854 patients were enrolled in the study, only 4852 of these entered and were included in the treated set, since two patients had no evidence of Spiriva administration.
Participant milestones
| Measure |
Patients Treated With Spiriva
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
|
|---|---|
|
Overall Study
STARTED
|
4852
|
|
Overall Study
COMPLETED
|
4712
|
|
Overall Study
NOT COMPLETED
|
140
|
Reasons for withdrawal
| Measure |
Patients Treated With Spiriva
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
|
|---|---|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
Protocol Violation
|
14
|
|
Overall Study
Lost to Follow-up
|
32
|
|
Overall Study
Other
|
72
|
Baseline Characteristics
Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region
Baseline characteristics by cohort
| Measure |
Patients Treated With Spiriva
n=4852 Participants
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
|
|---|---|
|
Age, Continuous
|
62.6 Years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
|
Sex/Gender, Customized
Male
|
3433 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Female
|
1391 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Missing
|
28 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Patients from the treated set (TS) who have evaluable SGRQ measurements at baseline and Visit 3 (6 months)
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Outcome measures
| Measure |
Patients Treated With Spiriva
n=4335 Participants
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
|
|---|---|
|
Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline
|
-21.73 Units on a scale
Standard Deviation 19.09
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Patients from Full Analysis Set (FAS) which includes all patients from the TS who were assessed after administration of Spiriva, i.e. who have evaluable SGRQ measurements at visit 2 or visit 3.
Pulmonary medication from baseline to visit 3 (6 months)
Outcome measures
| Measure |
Patients Treated With Spiriva
n=4435 Participants
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
|
|---|---|
|
Additional Bronchodilator or Inhaled Corticosteroids (ICS)
|
1146 Number of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Patients from FAS
Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10.
Outcome measures
| Measure |
Patients Treated With Spiriva
n=4435 Participants
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
|
|---|---|
|
Compliance of Patients
|
3636 Number of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: TS
Outcome measures
| Measure |
Patients Treated With Spiriva
n=4852 Participants
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
|
|---|---|
|
Patients With Any Adverse Events
|
182 Number of participants
|
Adverse Events
Patients Treated With Spiriva
Serious adverse events
| Measure |
Patients Treated With Spiriva
n=4852 participants at risk
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
|
|---|---|
|
Nervous system disorders
Brain oedema
|
0.02%
1/4852 • 6 months
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.02%
1/4852 • 6 months
|
|
Nervous system disorders
Somnolence
|
0.02%
1/4852 • 6 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.02%
1/4852 • 6 months
|
|
Cardiac disorders
Cardiac failure
|
0.02%
1/4852 • 6 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.02%
1/4852 • 6 months
|
|
Cardiac disorders
Myocardial infarction
|
0.02%
1/4852 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
5/4852 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.02%
1/4852 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.02%
1/4852 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumonia
|
0.02%
1/4852 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.02%
1/4852 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.02%
1/4852 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.02%
1/4852 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.02%
1/4852 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.02%
1/4852 • 6 months
|
|
Gastrointestinal disorders
Tongue neoplasm malignant stage unspecified
|
0.02%
1/4852 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.02%
1/4852 • 6 months
|
|
General disorders
Death
|
0.02%
1/4852 • 6 months
|
|
General disorders
Pyrexia
|
0.02%
1/4852 • 6 months
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.02%
1/4852 • 6 months
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.02%
1/4852 • 6 months
|
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 Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER