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Trial record 31 of 10804 for:    Placebo AND once

Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma

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ClinicalTrials.gov Identifier: NCT01634113
Recruitment Status : Completed
First Posted : July 6, 2012
Results First Posted : June 23, 2015
Last Update Posted : June 23, 2015
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-bromide
Drug: placebo
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Period Title: Overall Study
Started 34 36 32
Completed 34 36 31
Not Completed 0 0 1
Reason Not Completed
Not treated             0             0             1
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5 Total
Hide Arm/Group Description Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler. Total of all reporting groups
Overall Number of Baseline Participants 34 36 31 101
Hide Baseline Analysis Population Description
Treated set which included all randomised patients who received at least one dose of trial medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 36 participants 31 participants 101 participants
3.2  (1.4) 3.1  (1.5) 3.1  (1.3) 3.1  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 36 participants 31 participants 101 participants
Female
13
  38.2%
17
  47.2%
10
  32.3%
40
  39.6%
Male
21
  61.8%
19
  52.8%
21
  67.7%
61
  60.4%
1.Primary Outcome
Title Weekly Mean Combined Daytime Asthma Symptom Score
Hide Description

Change from baseline in the weekly mean combined daytime asthma symptom score as assessed by the Paediatric Asthma Caregivers Diary (PACD) in the last week of the 12 week treatment period.

The PACD is a diary designed to evaluate daily asthma symptoms in children aged 2-5 years. The diary consists of three questions to be answered each morning, when the child wakes up, and seven questions to be answered each evening, right after the child goes to bed for the night. A week was defined as 7 days.

The combined daytime score is the average of scores from questions 4 – 7 in the diary which are questions regarding severity of cough, wheezing, trouble breathing and interference with activities, scores for each question range from 0 (best) to 5 (worst). The week 12 weekly mean is the mean of the responses for each day averaged over the 7 days in week 12, so combined daytime asthma symptom scores also range from 0 (best) to 5 (worst).

The measured values presented are adjusted means.

Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, which included all randomised patients who received at least one dose of trial medication, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 34 36 30
Mean (Standard Error)
Unit of Measure: units on a scale
-0.456  (0.084) -0.535  (0.082) -0.504  (0.089)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tio R2.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4963
Comments All treatment comparisons were exploratory, no formal hypothesis testing was performed.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.080
Confidence Interval (2-Sided) 95%
-0.312 to 0.152
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.117
Estimation Comments Difference calculated as Tio R2.5 minus placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tio R5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6936
Comments All treatment comparisons were exploratory, no formal hypothesis testing was performed.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.048
Confidence Interval (2-Sided) 95%
-0.292 to 0.195
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.123
Estimation Comments Difference calculated as Tio R5 minus placebo
2.Primary Outcome
Title FEV1 Peak (0-3h) Change From Baseline
Hide Description Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak (0-3h)) measured at week 12
Time Frame 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 4 7 2
Mean (Standard Deviation)
Unit of Measure: Litres
0.158  (0.026) 0.130  (0.125) 0.145  (0.078)
3.Secondary Outcome
Title Weekly Mean Overnight Asthma Symptom Score Response
Hide Description

Change from baseline in the weekly mean overnight asthma symptom score response as assessed by the PACD in the last week of the 12 week treatment period.

The overnight score is the score from the following question in the PACD, "How much did your child cough last night after your child was put to bed for the night until he/she awoke this morning?". This endpoint was determined only for patients with 2 or more nights with symptoms per week during the baseline period. In this case, the baseline period is the 7 days used to derive the baseline value. A patient has a night with symptoms if the question was answered with scores 1, 2, 3, 4 or 5 or the patient received β-Agonist at least one time since he/she went to bed. A week was defined as 7 days.

Scores range from 0 (best) to 4 (worst), a value of 5 indicates severity of symptoms is unknown.

The measured values presented are adjusted means

Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 31 31 28
Mean (Standard Error)
Unit of Measure: units on a scale
-0.671  (0.110) -0.588  (0.111) -0.655  (0.116)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tio R2.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5995
Comments All treatment comparisons were exploratory, no formal hypothesis testing was performed.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.083
Confidence Interval (2-Sided) 95%
-0.229 to 0.394
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.157
Estimation Comments Difference calculated as Tio R2.5 minus placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tio R5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9251
Comments All treatment comparisons were exploratory, no formal hypothesis testing was performed.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.015
Confidence Interval (2-Sided) 95%
-0.303 to 0.333
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.160
Estimation Comments Difference calculated as Tio R5 minus placebo
4.Secondary Outcome
Title Weekly Percentage of Days Without Asthma Symptoms
Hide Description

Weekly Percentage of days without asthma symptoms at week 12.

A day without asthma symptoms was defined as a day during which the patient experienced no asthma symptoms, did not use rescue medication (salbutamol/albuterol) and had no asthma exacerbation/worsening requiring systemic corticosteroids, or unscheduled visits to a doctor’s office, emergency department, or hospital. A week was defined as 7 days.

The measured values presented are adjusted means

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 34 36 30
Mean (Standard Error)
Unit of Measure: percentage of days
53.151  (7.405) 55.401  (7.181) 50.654  (7.873)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tio R2.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8279
Comments All treatment comparisons were exploratory, no formal hypothesis testing was performed.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.250
Confidence Interval (2-Sided) 95%
-18.243 to 22.743
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.324
Estimation Comments Difference calculated as Tio R2.5 minus placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tio R5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8181
Comments All treatment comparisons were exploratory, no formal hypothesis testing was performed.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.497
Confidence Interval (2-Sided) 95%
-23.987 to 18.994
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.826
Estimation Comments Difference calculated as Tio R5 minus placebo
5.Secondary Outcome
Title Weekly Percentage of Days With Use of Salbutamol (Albuterol) Rescue Medication
Hide Description Weekly percentage of days with use of salbutamol (albuterol) rescue medication at week 12. A week was defined as 7 days.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 34 36 30
Mean (Standard Deviation)
Unit of Measure: percentage of days
24.94  (36.80) 24.23  (36.86) 24.88  (38.45)
6.Secondary Outcome
Title Weekly Mean Nighttime Awakenings Due to Asthma Symptoms
Hide Description

Change from baseline in the weekly mean nighttime awakenings due to asthma symptoms as assessed by the PACD, in the last week of the 12 week treatment period.

The weekly mean was calculated as the average of the weekly scores for the question “Did your child wake up during the night due to his/her asthma?” The question was answered on a 5-point verbal rating scale, with scores ranging from 1 (did not wake up) to 5 (was awake all night). A week was defined as 7 days.

The measured values presented are adjusted means

Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 34 36 31
Mean (Standard Error)
Unit of Measure: units on a scale
-0.318  (0.080) -0.257  (0.078) -0.392  (0.084)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tio R2.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5869
Comments All treatment comparisons were exploratory, no formal hypothesis testing was performed.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.061
Confidence Interval (2-Sided) 95%
-0.161 to 0.283
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.112
Estimation Comments Difference calculated as Tio R2.5 minus placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Respimat, Tio R5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5230
Comments All treatment comparisons were exploratory, no formal hypothesis testing was performed.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.075
Confidence Interval (2-Sided) 95%
-0.305 to 0.156
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.116
Estimation Comments Difference calculated as Tio R5 minus placebo
7.Secondary Outcome
Title Trough FEV1 Change From Baseline
Hide Description Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 4 7 2
Mean (Standard Deviation)
Unit of Measure: Litres
0.060  (0.032) 0.017  (0.108) 0.085  (0.163)
8.Secondary Outcome
Title FEV1 AUC (0-3h) Change From Baseline
Hide Description Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Time Frame 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 4 7 2
Mean (Standard Deviation)
Unit of Measure: Litres
0.104  (0.043) 0.072  (0.114) 0.077  (0.116)
9.Secondary Outcome
Title FVC Peak (0-3h) Change From Baseline
Hide Description Change from baseline in maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak (0–3h)) after 12 weeks of treatment.
Time Frame 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 4 7 2
Mean (Standard Deviation)
Unit of Measure: Litres
0.210  (0.054) 0.136  (0.143) 0.060  (0.085)
10.Secondary Outcome
Title Trough FVC Change From Baseline
Hide Description Change from baseline of trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 12 weeks of treatment.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 4 7 2
Mean (Standard Deviation)
Unit of Measure: Litres
0.155  (0.060) -0.027  (0.133) -0.050  (0.226)
11.Secondary Outcome
Title FVC AUC (0-3h) Change From Baseline
Hide Description Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Time Frame 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 4 7 2
Mean (Standard Deviation)
Unit of Measure: Litres
0.164  (0.037) 0.035  (0.105) 0.003  (0.130)
12.Secondary Outcome
Title Individual FEV1 Measurements
Hide Description Change from baseline in individual FEV1 measurements at each timepoint after 12 weeks
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 4 7 2
Mean (Standard Deviation)
Unit of Measure: Litres
Time: 0 hours 0.06  (0.03) 0.02  (0.11) 0.09  (0.16)
Time: 30 minutes 0.11  (0.09) 0.03  (0.13) 0.12  (0.11)
Time: 1 hour 0.11  (0.08) 0.10  (0.13) 0.12  (0.04)
Time: 2 hours 0.12  (0.05) 0.09  (0.13) 0.04  (0.16)
Time: 3 hours 0.10  (0.05) 0.06  (0.13) 0.05  (0.11)
13.Secondary Outcome
Title Individual FVC Measurements
Hide Description Change from baseline in individual FVC measurements at each timepoint after 12 weeks
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description:
Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
Overall Number of Participants Analyzed 4 7 2
Mean (Standard Deviation)
Unit of Measure: Litres
Time: 0 hours 0.16  (0.06) -0.03  (0.13) -0.05  (0.23)
Time: 30 minutes 0.13  (0.07) 0.04  (0.15) 0.06  (0.08)
Time: 1 hour 0.18  (0.04) 0.06  (0.14) 0.05  (0.10)
Time: 2 hours 0.16  (0.04) 0.02  (0.10) -0.03  (0.16)
Time: 3 hours 0.19  (0.07) 0.04  (0.13) -0.03  (0.13)
Time Frame From first drug intake until 30 days after last drug intake, up to 119 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Respimat Tio R2.5 Tio R5
Hide Arm/Group Description Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
All-Cause Mortality
Placebo Respimat Tio R2.5 Tio R5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Respimat Tio R2.5 Tio R5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/34 (8.82%)   0/36 (0.00%)   0/31 (0.00%) 
Infections and infestations       
Appendicitis  1  1/34 (2.94%)  0/36 (0.00%)  0/31 (0.00%) 
Bronchopneumonia  1  1/34 (2.94%)  0/36 (0.00%)  0/31 (0.00%) 
Viral upper respiratory tract infection  1  1/34 (2.94%)  0/36 (0.00%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/34 (2.94%)  0/36 (0.00%)  0/31 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Respimat Tio R2.5 Tio R5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/34 (70.59%)   19/36 (52.78%)   16/31 (51.61%) 
Gastrointestinal disorders       
Dry mouth  1  2/34 (5.88%)  0/36 (0.00%)  1/31 (3.23%) 
Mouth ulceration  1  2/34 (5.88%)  0/36 (0.00%)  0/31 (0.00%) 
Vomiting  1  3/34 (8.82%)  3/36 (8.33%)  1/31 (3.23%) 
General disorders       
Pyrexia  1  6/34 (17.65%)  3/36 (8.33%)  3/31 (9.68%) 
Infections and infestations       
Bronchitis  1  4/34 (11.76%)  1/36 (2.78%)  2/31 (6.45%) 
Ear infection  1  2/34 (5.88%)  1/36 (2.78%)  1/31 (3.23%) 
Gastroenteritis  1  0/34 (0.00%)  0/36 (0.00%)  2/31 (6.45%) 
Nasopharyngitis  1  5/34 (14.71%)  7/36 (19.44%)  2/31 (6.45%) 
Pharyngitis  1  2/34 (5.88%)  0/36 (0.00%)  0/31 (0.00%) 
Pneumonia  1  2/34 (5.88%)  1/36 (2.78%)  0/31 (0.00%) 
Respiratory tract infection viral  1  4/34 (11.76%)  3/36 (8.33%)  3/31 (9.68%) 
Rhinitis  1  3/34 (8.82%)  2/36 (5.56%)  3/31 (9.68%) 
Sinusitis  1  2/34 (5.88%)  1/36 (2.78%)  1/31 (3.23%) 
Upper respiratory tract infection  1  1/34 (2.94%)  3/36 (8.33%)  5/31 (16.13%) 
Nervous system disorders       
Headache  1  0/34 (0.00%)  2/36 (5.56%)  1/31 (3.23%) 
Reproductive system and breast disorders       
Balanoposthitis  1  0/34 (0.00%)  0/36 (0.00%)  2/31 (6.45%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  9/34 (26.47%)  5/36 (13.89%)  2/31 (6.45%) 
Cough  1  3/34 (8.82%)  4/36 (11.11%)  2/31 (6.45%) 
Nasal congestion  1  1/34 (2.94%)  3/36 (8.33%)  1/31 (3.23%) 
Rhinitis allergic  1  0/34 (0.00%)  2/36 (5.56%)  0/31 (0.00%) 
Rhinorrhoea  1  3/34 (8.82%)  0/36 (0.00%)  3/31 (9.68%) 
Wheezing  1  0/34 (0.00%)  2/36 (5.56%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders       
Urticaria  1  2/34 (5.88%)  1/36 (2.78%)  1/31 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.1
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01634113     History of Changes
Other Study ID Numbers: 205.443
2011-005512-28 ( EudraCT Number: EudraCT )
First Submitted: April 16, 2012
First Posted: July 6, 2012
Results First Submitted: June 3, 2015
Results First Posted: June 23, 2015
Last Update Posted: June 23, 2015