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.

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01233284

First received: November 2, 2010

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Results First Received: December 14, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double-Blind; 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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 149 patients were randomised and treated, 141 patients completed the trial.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups

	Description
Tio R5 Once Daily(qd)/Tio R1.25 qd/Placebo/Tio R2.5 qd	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.
Tio R2.5 qd/Placebo/Tio R1.25 qd/Tio R5 qd	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.
Tio R1.25 qd/Tio R2.5 qd/Tio R5 qd/Placebo	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.
Placebo/Tio R5 qd/Tio R2.5 qd/Tio R1.25 qd	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.
Placebo/Tio R2.5 qd/Tio R5 qd/Tio R1.25 qd	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.

Participant Flow for 4 periods

Period 1: Period 1 (4 Weeks)

	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
STARTED	37	38	38	35	1
COMPLETED	36	37	37	35	1
NOT COMPLETED	1	1	1	0	0
Lost to Follow-up	1	0	0	0	0
Withdrawal by Subject	0	1	0	0	0
Unknown	0	0	1	0	0

Period 2: Period 2 (4 Weeks)

	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
STARTED	36	37	37	35	1
COMPLETED	36	37	36	35	1
NOT COMPLETED	0	0	1	0	0
Withdrawal by Subject	0	0	1	0	0

Period 3: Period 3 (4 Weeks)

	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
STARTED	36	37	36	35	1
COMPLETED	36	37	35	34	1
NOT COMPLETED	0	0	1	1	0
Withdrawal by Subject	0	0	1	0	0
Unknown	0	0	0	1	0

Period 4: Period 4 (4 Weeks)

	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
STARTED	36	37	35	34	1
COMPLETED	36	36	35	33	1
NOT COMPLETED	0	1	0	1	0
Adverse Event	0	1	0	0	0
Lost to Follow-up	0	0	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
Baseline Total	Total number of patients randomised and treated in the study.

Baseline Measures

	Baseline Total
Number of Participants [units: participants]	149
Age [units: years] Mean ± Standard Deviation	49.3 ± 13.3
Gender [units: Participants]
Female	82
Male	67

Outcome Measures

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1. Primary:

Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response [ Time Frame: Baseline and 4 weeks ]

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2. Secondary:

Trough FEV1 Response [ Time Frame: Baseline and 4 weeks ]

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3. Secondary:

FEV1 Area Under the Curve 0-3 Hours (AUC0-3h) Response [ Time Frame: Baseline and 4 weeks ]

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4. Secondary:

Forced Vital Capacity (FVC) Peak Within 0-3 Hours Post-dose Response [ Time Frame: Baseline and 4 weeks ]

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5. Secondary:

Trough FVC Response [ Time Frame: Baseline and 4 weeks ]

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6. Secondary:

FVC AUC0-3h Response [ Time Frame: Baseline and 4 weeks ]

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7. Secondary:

Individual FEV1 Over Time (at Each Timepoint at Visits) Response [ Time Frame: Baseline and 4 weeks ]

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8. Secondary:

Individual FVC Over Time (at Each Timepoint at Visits) Response [ Time Frame: Baseline and 4 weeks ]

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9. Secondary:

Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response [ Time Frame: Baseline and 4 weeks ]

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10. Secondary:

Mean Pre-dose Morning PEF (PEF a.m.) Response During the Last Week on Treatment [ Time Frame: Baseline and 4 weeks ]

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11. Secondary:

Mean Pre-dose Evening PEF (PEF p.m.) Response During the Last Week on Treatment [ Time Frame: Baseline and 4 weeks ]

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12. Secondary:

PEF Variability Response (Last Week on Treatment) [ Time Frame: Baseline and 4 weeks ]

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13. Secondary:

Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values) [ Time Frame: Baseline and 4 weeks ]

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14. Secondary:

Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values) [ Time Frame: Baseline and 4 weeks ]

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15. Secondary:

Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values) [ Time Frame: Baseline and 4 weeks ]

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16. Secondary:

Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values) [ Time Frame: Baseline and 4 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01233284 History of Changes
Other Study ID Numbers:	205.380, 2010-018471-26
Study First Received:	November 2, 2010
Results First Received:	December 14, 2012
Last Updated:	January 23, 2013
Health Authority:	Austria: Federal Office for Safety in Health Care Germany: Federal Institute for Drugs and Medical Devices Ukraine: State Pharmacological Center - Ministry of Health

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