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Trial record 23 of 11010 for:    Placebo AND once

Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01340209
Recruitment Status : Completed
First Posted : April 22, 2011
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Tiotropium Respimat
Drug: Placebo Respimat
Enrollment 285
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Period Title: Overall Study
Started 57 114 114
Completed 52 106 106
Not Completed 5 8 8
Reason Not Completed
Adverse Event             1             1             2
Protocol Violation             1             2             1
Withdrawal by Subject             0             0             1
Other reason not defined above             3             5             4
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg) Total
Hide Arm/Group Description Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler Total of all reporting groups
Overall Number of Baseline Participants 57 114 114 285
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 114 participants 114 participants 285 participants
47.8  (13.0) 44.7  (12.1) 42.6  (12.8) 44.5  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 114 participants 114 participants 285 participants
Female
38
  66.7%
72
  63.2%
66
  57.9%
176
  61.8%
Male
19
  33.3%
42
  36.8%
48
  42.1%
109
  38.2%
1.Primary Outcome
Title Number of Patients With Drug-related Adverse Events
Hide Description The primary endpoint is the number of patients with drug-related adverse events
Time Frame after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set: all randomised patients who received at least 1 dose of study medication
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 57 114 114
Measure Type: Number
Unit of Measure: participants
3 6 10
2.Secondary Outcome
Title Trough FEV1 Response
Hide Description Trough FEV1 response was defined as change from baseline at week 52
Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all patients of the treated set for which baseline and at least 1 post-baseline efficacy measurement were available
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 56 114 114
Least Squares Mean (Standard Error)
Unit of Measure: Liter
0.075  (0.039) 0.087  (0.027) 0.187  (0.027)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (2.5 µg)
Comments Difference calculated as Tiotropium 2.5 µg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7971
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.012
Confidence Interval (2-Sided) 95%
-0.082 to 0.106
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.048
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (5 μg)
Comments Difference calculated as Tiotropium 5 μg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0203
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.112
Confidence Interval (2-Sided) 95%
0.018 to 0.207
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.048
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Trough FVC Response
Hide Description Trough FVC response was defined as change from baseline at week 52
Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 56 114 114
Least Squares Mean (Standard Error)
Unit of Measure: Liter
0.122  (0.044) 0.085  (0.030) 0.204  (0.031)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (2.5 µg)
Comments Difference calculated as Tiotropium 2.5 µg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4944
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.037
Confidence Interval (2-Sided) 95%
-0.141 to 0.068
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.053
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (5 μg)
Comments Difference calculated as Tiotropium 5 μg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1270
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.082
Confidence Interval (2-Sided) 95%
-0.023 to 0.188
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.054
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Trough PEF Response
Hide Description Trough PEF response was defined as change from baseline at week 52
Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 56 114 114
Least Squares Mean (Standard Error)
Unit of Measure: L/min
35.078  (10.119) 35.576  (6.917) 69.254  (7.004)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (2.5 µg)
Comments Difference calculated as Tiotropium 2.5 µg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9677
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.498
Confidence Interval (2-Sided) 95%
-23.634 to 24.630
Parameter Dispersion
Type: Standard Error of the mean
Value: 12.282
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (5 μg)
Comments Difference calculated as Tiotropium Respimat 5 μg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 34.176
Confidence Interval (2-Sided) 95%
9.919 to 58.432
Parameter Dispersion
Type: Standard Error of the mean
Value: 12.346
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Weekly Mean PEFam Response
Hide Description Weekly mean PEFam response was defined as change from baseline at week 52
Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 56 114 114
Least Squares Mean (Standard Error)
Unit of Measure: L/min
2.288  (7.554) 10.934  (5.231) 8.504  (5.267)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (2.5 µg)
Comments Difference calculated as Tiotropium 2.5 µg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3468
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.646
Confidence Interval (2-Sided) 95%
-9.388 to 26.680
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.182
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (5 μg)
Comments Difference calculated as Tiotropium 5 μg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5013
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.216
Confidence Interval 95%
-11.927 to 24.359
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.238
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Weekly Mean PEFpm Response
Hide Description Weekly mean PEFpm response was defined as change from baseline at week 52
Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 56 114 114
Least Squares Mean (Standard Error)
Unit of Measure: L/min
-10.357  (7.566) 1.101  (5.239) 6.041  (5.284)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (2.5 µg)
Comments Difference calculated as Tiotropium 2.5 µg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2132
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.458
Confidence Interval (2-Sided) 95%
-6.601 to 29.517
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.196
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (5 μg)
Comments Difference calculated as Tiotropium 5 μg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0766
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.398
Confidence Interval (2-Sided) 95%
-1.759 to 34.555
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.245
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Weekly Mean PEF Variability Response
Hide Description

Weekly mean PEF variability response was defined as change from baseline at week 52.

The PEF variability is the absolute difference between morning and evening PEF value, divided by their mean, expressed as a percent. Response was defined as change from baseline.

Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 56 114 114
Least Squares Mean (Standard Error)
Unit of Measure: percentage
-0.367  (0.851) -0.968  (0.595) 0.197  (0.595)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (2.5 µg)
Comments Difference calculated as Tiotropium 2.5 µg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5629
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.601
Confidence Interval (2-Sided) 95%
-2.637 to 1.436
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.038
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tiotropium Respimat (5 μg)
Comments Difference calculated as Tiotropium 5 μg minus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5871
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for treatment, week, baseline, treatment*week and baseline*week
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.564
Confidence Interval (2-Sided) 95%
-1.473 to 2.601
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.038
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)
Hide Description Response of weekly mean number of puffs of rescue medication during the whole day at week 52. Response was defined as change from baseline.
Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 50 105 103
Mean (Standard Deviation)
Unit of Measure: Puffs
-0.25  (0.77) -0.29  (1.01) -0.22  (0.96)
9.Secondary Outcome
Title Weekly Mean Score of Asthma Symptoms in the Morning (Response)
Hide Description

Response of weekly mean score of asthma symptoms in the morning at week 52. Response was defined as change from baseline.

5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment.

Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 50 103 103
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.22  (0.43) -0.14  (0.49) -0.21  (0.43)
10.Secondary Outcome
Title Weekly Mean Score of Asthma Symptoms During the Day (Response)
Hide Description

Response of weekly mean score of asthma symptoms during the day at week 52. Response was defined as change from baseline.

5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment.

Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description:
Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
Overall Number of Participants Analyzed 50 105 103
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.24  (0.35) -0.15  (0.48) -0.17  (0.48)
Time Frame after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Hide Arm/Group Description Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
All-Cause Mortality
Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/57 (15.79%)   4/114 (3.51%)   4/114 (3.51%) 
Gastrointestinal disorders       
Mesenteric haemorrhage  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Subileus  1  0/57 (0.00%)  0/114 (0.00%)  1/114 (0.88%) 
General disorders       
Cyst  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Infections and infestations       
Cellulitis  1  0/57 (0.00%)  1/114 (0.88%)  0/114 (0.00%) 
Diverticulitis  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Influenza  1  0/57 (0.00%)  1/114 (0.88%)  0/114 (0.00%) 
Pneumonia bacterial  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Injury, poisoning and procedural complications       
Rib fracture  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Sternal fracture  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  0/57 (0.00%)  0/114 (0.00%)  1/114 (0.88%) 
Pain in extremity  1  0/57 (0.00%)  1/114 (0.88%)  0/114 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Oral papilloma  1  0/57 (0.00%)  1/114 (0.88%)  0/114 (0.00%) 
Nervous system disorders       
Loss of consciousness  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst  1  0/57 (0.00%)  0/114 (0.00%)  1/114 (0.88%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/57 (1.75%)  0/114 (0.00%)  1/114 (0.88%) 
Vascular disorders       
Aortic dissection  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Deep vein thrombosis  1  1/57 (1.75%)  0/114 (0.00%)  0/114 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Respimat Tiotropium Respimat (2.5 µg) Tiotropium Respimat (5 μg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/57 (87.72%)   97/114 (85.09%)   101/114 (88.60%) 
Gastrointestinal disorders       
Constipation  1  3/57 (5.26%)  0/114 (0.00%)  1/114 (0.88%) 
Gastritis  1  4/57 (7.02%)  3/114 (2.63%)  6/114 (5.26%) 
Gastrooesophageal reflux disease  1  1/57 (1.75%)  1/114 (0.88%)  6/114 (5.26%) 
Infections and infestations       
Bronchitis  1  4/57 (7.02%)  15/114 (13.16%)  11/114 (9.65%) 
Gastroenteritis  1  3/57 (5.26%)  4/114 (3.51%)  12/114 (10.53%) 
Influenza  1  2/57 (3.51%)  6/114 (5.26%)  5/114 (4.39%) 
Nasopharyngitis  1  24/57 (42.11%)  51/114 (44.74%)  55/114 (48.25%) 
Pharyngitis  1  2/57 (3.51%)  15/114 (13.16%)  9/114 (7.89%) 
Upper respiratory tract infection  1  2/57 (3.51%)  8/114 (7.02%)  5/114 (4.39%) 
Injury, poisoning and procedural complications       
Ligament sprain  1  3/57 (5.26%)  2/114 (1.75%)  3/114 (2.63%) 
Investigations       
Peak expiratory flow rate decreased  1  12/57 (21.05%)  9/114 (7.89%)  18/114 (15.79%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  3/57 (5.26%)  4/114 (3.51%)  4/114 (3.51%) 
Nervous system disorders       
Headache  1  1/57 (1.75%)  7/114 (6.14%)  4/114 (3.51%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  21/57 (36.84%)  34/114 (29.82%)  32/114 (28.07%) 
Dysphonia  1  0/57 (0.00%)  2/114 (1.75%)  7/114 (6.14%) 
Rhinitis allergic  1  4/57 (7.02%)  3/114 (2.63%)  2/114 (1.75%) 
Upper respiratory tract inflammation  1  4/57 (7.02%)  7/114 (6.14%)  7/114 (6.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.0
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
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
ClinicalTrials.gov Identifier: NCT01340209     History of Changes
Other Study ID Numbers: 205.464
First Submitted: April 13, 2011
First Posted: April 22, 2011
Results First Submitted: April 22, 2014
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014