4 Week 2 Way Crossover Double Blind Treatment Phase With Combivent CFC Versus Albuterol Followed by a 4 Week Open Label Combivent Respimat When All Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00818454

First received: January 6, 2009

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: September 21, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Combivent CFC MDI Drug: Albuterol HFA MDI Drug: Respimat Combivent

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
Crossover Part of the Study (Treatment Period 1) Crossover Part of the Study (Washout Period of 1 Week) Crossover Part of the Study (Treatment Period 2) Parallel Part of the Study Following Second Randomization (Treatment Period 3)

Pre-Assignment Details

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

	Description
Albuterol HFA First, Then Combivent CFC	Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
Combivent CFC First, Then Albuterol HFA	Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
Placebo Respimat	No text entered.
Combivent Respimat	No text entered.

Participant Flow for 4 periods

Period 1: Treatment Period 1

	Albuterol HFA First, Then Combivent CFC	Combivent CFC First, Then Albuterol HFA
STARTED	115	111
COMPLETED	112	110
NOT COMPLETED	3	1
Adverse Event	0	1
not specified	3	0

Period 2: Washout Period of 1 Week

	Albuterol HFA First, Then Combivent CFC	Combivent CFC First, Then Albuterol HFA
STARTED	112	110
COMPLETED	108	107
NOT COMPLETED	4	3
Adverse Event	1	1
Protocol Violation	2	0
not specified	1	2

Period 3: Treatment Period 2

	Albuterol HFA First, Then Combivent CFC	Combivent CFC First, Then Albuterol HFA
STARTED	108	107
COMPLETED	106	106
NOT COMPLETED	2	1
not specified	2	1

Period 4: Treatment Period 3

	Placebo Respimat	Combivent Respimat
STARTED	26	139
COMPLETED	26	138
NOT COMPLETED	0	1
Adverse Event	0	1

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Participants randomized to crossover part at randomization 1

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	226
Age [units: Years] Mean ± Standard Deviation	47.1 ± 13.7
Gender [units: Participants]
Female	130
Male	96
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	11
Not Hispanic or Latino	215
Race/Ethnicity, Customized [units: Participants]
Amer. Ind./Alaska Nat	1
Asian	2
Black/African Amer.	44
Hawaiian/Pacif. Isle	5
White	174
Body mass index [units: Kilograms per square meter] Mean ± Standard Deviation	31.1 ± 6.7
Smoking history [units: Participants]
Never smoked	163
Ex-smoker	63
Currently smokes	0
Alcohol history [units: Participants]
Non drinker	76
Drinks - no interference	150
Drinks - possible interference	0
Height [units: Centimeters] Mean ± Standard Deviation	169.9 ± 11.0
Weight [units: Kilograms] Mean ± Standard Deviation	89.9 ± 21.0

Outcome Measures

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1. Primary:

FEV1 AUC0-6 Response (Crossover Part of the Study) [ Time Frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks ]

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2. Primary:

Peak FEV1 Response (Crossover Part of the Study) [ Time Frame: Test day baseline and test day peak FEV1, after 4 weeks ]

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3. Secondary:

Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study) [ Time Frame: Baseline, 4 weeks ]

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4. Secondary:

Asthma Control Questionnaire (Crossover Part of the Study) [ Time Frame: Baseline, 4 weeks ]

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5. Secondary:

Puffs Study Medication Used During Day (Crossover Part of the Study) [ Time Frame: Baseline, 4 weeks ]

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6. Secondary:

Puffs Study Medication Used During Night (Crossover Part of the Study) [ Time Frame: Baseline, 4 weeks ]

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7. Secondary:

Puffs Open-label Albuterol Used During Day (Crossover Part of the Study) [ Time Frame: Baseline, 4 weeks ]

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8. Secondary:

Puffs Open-label Albuterol Used During Night (Crossover Part of the Study) [ Time Frame: Baseline, 4 weeks ]

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9. Secondary:

FEV1 AUC0-6 Response (Parallel Part of the Study) [ Time Frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks ]

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10. Secondary:

Peak FEV1 Response [ Time Frame: Test day baseline and test day peak FEV1, after 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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00818454 History of Changes
Other Study ID Numbers:	1012.57, 57948
Study First Received:	January 6, 2009
Results First Received:	September 21, 2010
Last Updated:	May 18, 2012
Health Authority:	United States: Food and Drug Administration

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