Randomised, Double- Blind, Cross-over Efficacy and Safety Comparison of Three Different Doses of Tiotropium Administered Once Daily Versus Placebo in Patients With Moderate 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: NCT01233284 |
|
Recruitment Status :
Completed
First Posted : November 3, 2010
Results First Posted : January 21, 2013
Last Update Posted : December 24, 2013
|
Sponsor:
Boehringer Ingelheim
Collaborator:
Pfizer
Information provided by (Responsible Party):
Boehringer Ingelheim
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double; Primary Purpose: Treatment |
| Condition |
Asthma |
| Interventions |
Drug: tiotropium bromide 2.5µg once daily Drug: Tiotropium matching Placebo once daily Drug: tiotropium bromide high dose once daily Drug: tiotropium bromide 1.25µg once daily |
| Enrollment | 149 |
Participant Flow
| Recruitment Details | A total of 149 patients were randomised and treated, 141 patients completed the trial. |
| Pre-assignment Details | Randomised, double-blind, placebo controlled, cross-over design without washout phase between the four periods. Patients were randomized to one of the 4 sequences (ABCD, DCBA, BDAC, CADB). For one patient treatment 2 and treatment 3 were interchanged (resulting sequence DBCA). |
| Arm/Group Title | Tio R5 Once Daily(qd)/Tio R1.25 qd/Placebo/Tio R2.5 qd | Tio R2.5 qd/Placebo/Tio R1.25 qd/Tio R5 qd | Tio R1.25 qd/Tio R2.5 qd/Tio R5 qd/Placebo | Placebo/Tio R5 qd/Tio R2.5 qd/Tio R1.25 qd | Placebo/Tio R2.5 qd/Tio R5 qd/Tio R1.25 qd |
|---|---|---|---|---|---|
 Arm/Group Description |
Patients treated with Tiotropium 5 mcg in period 1 (evening), with Tiotropium 1.25 mcg in period 2 (evening), with a matching Placebo in period 3 (evening) and with Tiotropium 2.5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroids (ICS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks. | Patients treated with Tiotropium 2.5 mcg in period 1 (evening), with a matching Placebo in period 2 (evening), with Tiotropium 1.25 mcg in period 3 (evening) and with Tiotropium 5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks. | Patients treated with Tiotropium 1.25 mcg in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with a matching placebo in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroid ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks. | Patients treated with a matching Placebo in period 1 (evening), with Tiotropium 5 mcg in period 2 (evening), with Tiotropium 2.5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks. | Patient treated with a matching Placebo in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks. |
| Period Title: Period 1 (4 Weeks) | |||||
| Started | 37 | 38 | 38 | 35 | 1 |
| Completed | 36 | 37 | 37 | 35 | 1 |
| Not Completed | 1 | 1 | 1 | 0 | 0 |
| Reason Not Completed | |||||
| Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
| Other | 0 | 0 | 1 | 0 | 0 |
| Period Title: Period 2 (4 Weeks) | |||||
| Started | 36 | 37 | 37 | 35 | 1 |
| Completed | 36 | 37 | 36 | 35 | 1 |
| Not Completed | 0 | 0 | 1 | 0 | 0 |
| Reason Not Completed | |||||
| Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
| Period Title: Period 3 (4 Weeks) | |||||
| Started | 36 | 37 | 36 | 35 | 1 |
| Completed | 36 | 37 | 35 | 34 | 1 |
| Not Completed | 0 | 0 | 1 | 1 | 0 |
| Reason Not Completed | |||||
| Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
| Other | 0 | 0 | 0 | 1 | 0 |
| Period Title: Period 4 (4 Weeks) | |||||
| Started | 36 | 37 | 35 | 34 | 1 |
| Completed | 36 | 36 | 35 | 33 | 1 |
| Not Completed | 0 | 1 | 0 | 1 | 0 |
| Reason Not Completed | |||||
| Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Baseline Total | |
|---|---|---|
|
Arm/Group Description |
Total number of patients randomised and treated in the study. | |
| Overall Number of Baseline Participants | 149 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||
| Number Analyzed | 149 participants | |
| 49.3 (13.3) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
| Number Analyzed | 149 participants | |
| Female |
82 55.0%
|
|
| Male |
67 45.0%
|
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
| EMail: | clintriage.rdg@boehringer-ingelheim.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01233284 |
| Other Study ID Numbers: |
205.380 2010-018471-26 ( EudraCT Number: EudraCT ) |
| First Submitted: | November 2, 2010 |
| First Posted: | November 3, 2010 |
| Results First Submitted: | December 14, 2012 |
| Results First Posted: | January 21, 2013 |
| Last Update Posted: | December 24, 2013 |