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Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region

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ClinicalTrials.gov Identifier: NCT01006135
Recruitment Status : Completed
First Posted : November 2, 2009
Results First Posted : July 9, 2012
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Time Perspective: Prospective
Condition Pulmonary Disease, Chronic Obstructive
Enrollment 4852
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Patients Treated With Spiriva
Hide Arm/Group Description Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
Period Title: Overall Study
Started 4852
Completed 4712
Not Completed 140
Reason Not Completed
Adverse Event             22
Protocol Violation             14
Lost to Follow-up             32
Other             72
Arm/Group Title Patients Treated With Spiriva
Hide Arm/Group Description Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
Overall Number of Baseline Participants 4852
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4852 participants
62.6  (9.8)
[1]
Measure Description: There were only 4779 patients with a non-missing age.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4852 participants
Male 3433
Female 1391
Missing 28
1.Primary Outcome
Title Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline
Hide Description The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from the treated set (TS) who have evaluable SGRQ measurements at baseline and Visit 3 (6 months)
Arm/Group Title Patients Treated With Spiriva
Hide Arm/Group Description:
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
Overall Number of Participants Analyzed 4335
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-21.73  (19.09)
2.Secondary Outcome
Title Additional Bronchodilator or Inhaled Corticosteroids (ICS)
Hide Description Pulmonary medication from baseline to visit 3 (6 months)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Patients Treated With Spiriva
Hide Arm/Group Description:
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
Overall Number of Participants Analyzed 4435
Measure Type: Number
Unit of Measure: Number of participants
1146
3.Secondary Outcome
Title Compliance of Patients
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS
Arm/Group Title Patients Treated With Spiriva
Hide Arm/Group Description:
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
Overall Number of Participants Analyzed 4435
Measure Type: Number
Unit of Measure: Number of participants
3636
4.Secondary Outcome
Title Patients With Any Adverse Events
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Patients Treated With Spiriva
Hide Arm/Group Description:
Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
Overall Number of Participants Analyzed 4852
Measure Type: Number
Unit of Measure: Number of participants
182
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Treated With Spiriva
Hide Arm/Group Description Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
All-Cause Mortality
Patients Treated With Spiriva
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients Treated With Spiriva
Affected / at Risk (%)
Total   15/4852 (0.31%) 
Cardiac disorders   
Acute myocardial infarction  1  1/4852 (0.02%) 
Cardiac failure  1  1/4852 (0.02%) 
Cardiac failure acute  1  1/4852 (0.02%) 
Myocardial infarction  1  1/4852 (0.02%) 
Gastrointestinal disorders   
Tongue neoplasm malignant stage unspecified  1  1/4852 (0.02%) 
General disorders   
Death  1  1/4852 (0.02%) 
Pyrexia  1  1/4852 (0.02%) 
Injury, poisoning and procedural complications   
Post procedural complication  1  1/4852 (0.02%) 
Radiation skin injury  1  1/4852 (0.02%) 
Nervous system disorders   
Brain oedema  1  1/4852 (0.02%) 
Haemorrhagic stroke  1  1/4852 (0.02%) 
Somnolence  1  1/4852 (0.02%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  5/4852 (0.10%) 
Acute respiratory failure  1  1/4852 (0.02%) 
Asthma  1  1/4852 (0.02%) 
Bronchopneumonia  1  1/4852 (0.02%) 
Dyspnoea  1  1/4852 (0.02%) 
Lower respiratory tract infection  1  1/4852 (0.02%) 
Pneumonia  1  1/4852 (0.02%) 
Pulmonary oedema  1  1/4852 (0.02%) 
Respiratory failure  1  1/4852 (0.02%) 
Skin and subcutaneous tissue disorders   
Rash generalised  1  1/4852 (0.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Treated With Spiriva
Affected / at Risk (%)
Total   0/4852 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01006135     History of Changes
Other Study ID Numbers: 205.450
First Submitted: October 30, 2009
First Posted: November 2, 2009
Results First Submitted: June 2, 2012
Results First Posted: July 9, 2012
Last Update Posted: April 10, 2014