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Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example

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ClinicalTrials.gov Identifier: NCT01036763
Recruitment Status : Completed
First Posted : December 21, 2009
Results First Posted : March 22, 2012
Last Update Posted : March 27, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Time Perspective: Prospective
Condition Pulmonary Disease, Chronic Obstructive
Enrollment [Not Specified]
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description 1 capsule/2 puffs once daily at the same time
Period Title: Overall Study
Started 1264
Completed 1171
Not Completed 93
Reason Not Completed
Adverse Event             25
Lost to Follow-up             28
Other reason (not specified)             40
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description 1 capsule/2 puffs once daily at the same time
Overall Number of Baseline Participants 1264
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1264 participants
65.3  (10.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 1264 participants
< 65 years 569
>= 65 years 695
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1264 participants
Female
466
  36.9%
Male
798
  63.1%
1.Primary Outcome
Title Success of Treatment With Tiotropium According to Physician's Assessment
Hide Description Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful
Time Frame 6 - 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who were documented to have taken at least one dose of Spiriva®18 Microgram/Spiriva® Respimat® and had COPD requiring long-acting anticholinergics
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description:
1 capsule/2 puffs once daily at the same time
Overall Number of Participants Analyzed 1264
Measure Type: Number
Unit of Measure: Participants
Pulmonary function 620
Exercise capacity 618
Dyspnoea 452
Quality of life 412
Patient's opinion 235
Prevention of exacerbations 106
2.Primary Outcome
Title Assessment of Efficacy According to Physician
Hide Description Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Time Frame 6 - 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description:
1 capsule/2 puffs once daily at the same time
Overall Number of Participants Analyzed 1264
Measure Type: Number
Unit of Measure: Participants
Very good 342
Good 645
Satisfactory 172
Less satisfactory 44
Unsatisfactory 27
Missing 34
3.Primary Outcome
Title Assessment of Tolerability According to Physician
Hide Description Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Time Frame 6 - 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description:
1 capsule/2 puffs once daily at the same time
Overall Number of Participants Analyzed 1264
Measure Type: Number
Unit of Measure: Participants
Very good 601
Good 572
Satisfactory 35
Less satisfactory 9
Unsatisfactory 13
Missing 34
4.Primary Outcome
Title Assessment of Efficacy According to Patient
Hide Description patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Time Frame 6 - 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description:
1 capsule/2 puffs once daily at the same time
Overall Number of Participants Analyzed 1264
Measure Type: Number
Unit of Measure: Participants
Very good 339
Good 620
Satisfactory 169
Less satisfactory 55
Unsatisfactory 35
Missing 46
5.Primary Outcome
Title Assessment of Tolerability According to Patient
Hide Description Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Time Frame 6 - 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description:
1 capsule/2 puffs once daily at the same time
Overall Number of Participants Analyzed 1264
Measure Type: Number
Unit of Measure: Participants
Very good 564
Good 567
Satisfactory 54
Less satisfactory 14
Unsatisfactory 17
Missing 48
6.Secondary Outcome
Title Physician's Global Evaluation at Visit 1
Hide Description Physician’s global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores “Poor (1, 2)”, “Satisfactory (3, 4)”, “Good (5, 6)” and “Excellent (7, 8)” prior to treatment with Spiriva.
Time Frame 0 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description:
1 capsule/2 puffs once daily at the same time
Overall Number of Participants Analyzed 1264
Measure Type: Number
Unit of Measure: Participants
Excellent 8
Good 294
Satisfactory 755
Poor 206
Missing 1
7.Secondary Outcome
Title Physician's Global Evaluation at Visit 2
Hide Description Physician’s global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6–12 weeks of treatment with Spiriva.
Time Frame after 6 - 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description:
1 capsule/2 puffs once daily at the same time
Overall Number of Participants Analyzed 1264
Measure Type: Number
Unit of Measure: Participants
Excellent 61
Good 737
Satisfactory 407
Poor 31
Missing 28
Time Frame 6 - 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Spiriva® 18 Microgram/Spiriva® Respimat®
Hide Arm/Group Description 1 capsule/2 puffs once daily at the same time
All-Cause Mortality
Spiriva® 18 Microgram/Spiriva® Respimat®
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Spiriva® 18 Microgram/Spiriva® Respimat®
Affected / at Risk (%)
Total   5/1264 (0.40%) 
Cardiac disorders   
Coronary artery disease  1  1/1264 (0.08%) 
General disorders   
Condition aggravated  1  1/1264 (0.08%) 
Musculoskeletal and connective tissue disorders   
Osteoporotic fracture  1  1/1264 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastatic bronchial carcinoma  1  1/1264 (0.08%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/1264 (0.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Spiriva® 18 Microgram/Spiriva® Respimat®
Affected / at Risk (%)
Total   0/1264 (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
Publications:
Rau-Berger H, Kroker A, Mitfessel H, Schmidt H, Glaab T Assessment of COPD-therapy with tiotropium by the treating pneumologist. 53rd Cong of the German Respiratory Society, Nuremberg, 29 Mar - 1 Apr 2012 (Poster), (2012)
Glaab T, Kroker A, Mitfessel H, Schmdit H, Rau-Berger H Evaluation of COPD treatment success by office-based pneumologists using the example of tiotropium. 21st Ann Cong of the European Respiratory Society (ERS), Amsterdam, 24 - 28 Sep 2011 (Poster), (2011)
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01036763     History of Changes
Other Study ID Numbers: 205.455
First Submitted: December 18, 2009
First Posted: December 21, 2009
Results First Submitted: February 15, 2012
Results First Posted: March 22, 2012
Last Update Posted: March 27, 2014