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Special Survey Long-term Treatment With Tiotropium on COPD

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ClinicalTrials.gov Identifier: NCT00638183
Recruitment Status : Completed
First Posted : March 18, 2008
Results First Posted : April 5, 2010
Last Update Posted : June 19, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Pulmonary Disease, Chronic Obstructive
Enrollment 385
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Spiriva Treatment
Hide Arm/Group Description Daily Therapy
Period Title: Overall Study
Started 385
Completed 266
Not Completed 119
Reason Not Completed
Adverse Event             23
Lack of Efficacy             14
Physician Decision             9
Lost to Follow-up             46
Other reason not defined above             27
Arm/Group Title Spiriva Treatment
Hide Arm/Group Description Daily Therapy
Overall Number of Baseline Participants 249
Hide Baseline Analysis Population Description
Number of participants in this summary is "Number of patients eligible for efficacy analysis" Throughout this report, the discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 249 participants
<65 years 51
65≤ to <75 years 88
>=75 years 103
Unknown 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants
Female
37
  14.9%
Male
212
  85.1%
1.Primary Outcome
Title Number of Patients With Adverse Events (AEs)
Hide Description Number of patients with AEs
Time Frame Pre treatment and 52 weeks after the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
373 patients were involved in the safety analysis data
Arm/Group Title Spiriva Treatment
Hide Arm/Group Description:
Daily Therapy
Overall Number of Participants Analyzed 373
Measure Type: Number
Unit of Measure: Participants
71
2.Primary Outcome
Title Number of Patients With Adverse Drug Reactions (ADRs)
Hide Description Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.
Time Frame Pre treatment and 52 weeks after the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
373 patients were involved in the safety analysis data
Arm/Group Title Spiriva Treatment
Hide Arm/Group Description:
Daily Therapy
Overall Number of Participants Analyzed 373
Measure Type: Number
Unit of Measure: Participants
27
3.Secondary Outcome
Title Effective Rate of Comprehensive Evaluation
Hide Description

Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator.

Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided "comprehensive evaluation".

"comprehensive evaluation" was classified into 3 category, "improve" "No change+Aggravated" and "Unassessable" by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of "Improvement" in total number of analyzed patients

Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
249 patient were evaluated the efficacy
Arm/Group Title Spiriva Treatment
Hide Arm/Group Description:
Daily Therapy
Overall Number of Participants Analyzed 249
Measure Type: Number
Unit of Measure: percentage of effective patients
70.9
4.Secondary Outcome
Title Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks
Hide Description Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation
Time Frame Pre treatment and 52 weeks after the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients for which respiratory function testing was conducted at baseline and at 52 weeks
Arm/Group Title Spiriva Treatment
Hide Arm/Group Description:
Daily Therapy
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Liters
0.119  (0.208)
Time Frame 52 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Spiriva Treatment
Hide Arm/Group Description Daily Therapy
All-Cause Mortality
Spiriva Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Spiriva Treatment
Affected / at Risk (%)
Total   33/373 (8.85%) 
Cardiac disorders   
Angina pectoris  1  1/373 (0.27%) 
Cardiac failure  1  2/373 (0.54%) 
Cardiac failure congestive  1  1/373 (0.27%) 
Bradyarrhythmia  1  1/373 (0.27%) 
Left atrial dilatation  1  1/373 (0.27%) 
Cor pulmonale  1  1/373 (0.27%) 
Eye disorders   
Macular degeneration  1  1/373 (0.27%) 
Gastrointestinal disorders   
Colonic polyp  1  1/373 (0.27%) 
Ileus  1  1/373 (0.27%) 
Pancreatitis acute  1  1/373 (0.27%) 
General disorders   
Death  1  1/373 (0.27%) 
Infections and infestations   
Bronchitis  1  1/373 (0.27%) 
Diverticulitis  1  1/373 (0.27%) 
Infection  1  2/373 (0.54%) 
Pneumonia  1  6/373 (1.61%) 
Sepsis  1  1/373 (0.27%) 
Lung infection  1  1/373 (0.27%) 
Injury, poisoning and procedural complications   
Rib fracture  1  1/373 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung carcinoma cell type unspecified recurrent  1  1/373 (0.27%) 
Small cell lung cancer stage unspecified  1  1/373 (0.27%) 
Prostate cancer  1  1/373 (0.27%) 
Lung neoplasm malignant  1  2/373 (0.54%) 
Bladder cancer  1  1/373 (0.27%) 
Nervous system disorders   
Cerebral infarction  1  1/373 (0.27%) 
Dizziness  1  1/373 (0.27%) 
Loss of consciousness  1  1/373 (0.27%) 
Stupor  1  1/373 (0.27%) 
Renal and urinary disorders   
Neurogenic bladder  1  1/373 (0.27%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/373 (0.27%) 
Chronic obstructive pulmonary disease  1  5/373 (1.34%) 
Haemoptysis  1  1/373 (0.27%) 
Pneumothorax  1  2/373 (0.54%) 
Respiratory failure  1  2/373 (0.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Spiriva Treatment
Affected / at Risk (%)
Total   0/373 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00638183     History of Changes
Other Study ID Numbers: 205.315
First Submitted: March 11, 2008
First Posted: March 18, 2008
Results First Submitted: January 19, 2010
Results First Posted: April 5, 2010
Last Update Posted: June 19, 2014