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BELT: BLACKS & EXACERBATIONS ON LABA VS. TIOTROPIUM

Award Number: R01HS019408
ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY
OPDIV: AHRQ
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2010
PERIOD OF PERFORMANCE END DATE: 09/29/2013

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BELT: BLACKS & EXACERBATIONS ON LABA VS. TIOTROPIUM - DESCRIPTION (provided by applicant): Blacks bear a disproportionate burden of asthma morbidity and mortality. In its 2005 report on ethnic disparities in health care, AHRQ identified hospital admissions for asthma as the second largest disparity in quality of health care for Blacks versus Whites. Long-acting beta-agonists (LABAs), a popular treatment option for asthma, are in a class of drugs acting at ADRB2, which have been associated with rare loss of long-term asthma control and increased serious adverse outcomes including death and respiratory failure, even when used with ICS. The risk appears to be four to five-folds greater in Blacks than non-Black patients with asthma. Comparison of studies with LABA/ICS in Blacks versus studies where Blacks were a small minority suggests that Blacks may have much less benefit than other racial groups. Additionally, recent data (Wechsler 2009) suggest that a polymorphism at the 16th position of the ADRB2 gene identifies a group of Blacks (those homozygous for arginine (Arg16Arg)) in whom the response of adding a LABA to an ICS is further diminished. This polymorphism is present in ~20% of U.S. Blacks. In order to address the resulting knowledge gaps, a study is proposed to determine, in a one year practice-based, real-world, randomized, prospective, parallel group, longitudinal comparative effectiveness trial with the clinically important primary outcome of asthma exacerbations, whether in self-identified Black patients with asthma, treatment with LABA/ICS is superior to use of a non-2-adrenergic bronchodilator (tiotropium) combined with ICS (Tio/ICS). The study will also aim to determine, whether in the 20% of self-identified Black patients with asthma bearing Arg16Arg of ADRB2, treatment with LABA/ICS is superior to use of a non-2-adrenergic bronchodilator combined with ICS. PUBLIC HEALTH RELEVANCE: The results of this study will provide the information necessary to make evidence-based, individualized, recommendations concerning treatment algorithms and potential alternative treatment recommendations for the 3.5 million Blacks with asthma. The performance of this study in real life primary care settings will hasten the translation of these findings into day to day practice for this minority population that experiences a disproportionate burden of asthma and has been underrepresented in previous asthma studies.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2013 ( Subtotal = $0 )
2013	2010	Harvard Clinical Research Institution	930 Commonwealth Ave	BOSTON	MA	02215	SUFFOLK	USA	Recovery Act – Comparative Effectiveness Research - AHRQ	001	1	7/8/2013	NEW	$0
2013	2010	Harvard Clinical Research Institution	930 Commonwealth Ave	BOSTON	MA	02215	SUFFOLK	USA	Recovery Act – Comparative Effectiveness Research - AHRQ	000	1	4/8/2013	NEW	$0
														Subtotal = $0

Issue Date FY: 2012 ( Subtotal = $0 )
2012	2010	Harvard Clinical Research Institution	930 Commonwealth Ave	BOSTON	MA	02215	SUFFOLK	USA	Recovery Act – Comparative Effectiveness Research - AHRQ	000	1	9/27/2012	NEW	$0
														Subtotal = $0

Issue Date FY: 2011 ( Subtotal = $2,137,706 )
2011	2011	Harvard Clinical Research Institution	930 Commonwealth Ave	BOSTON	MA	02215	SUFFOLK	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	3/29/2011	SUPPLEMENT FOR EXPANSION	$2,137,706
2011	2010	Harvard Clinical Research Institution	930 Commonwealth Ave	BOSTON	MA	02215	SUFFOLK	USA	Recovery Act – Comparative Effectiveness Research - AHRQ	001	1	9/14/2011	NEW	$0
														Subtotal = $2,137,706

Issue Date FY: 2010 ( Subtotal = $7,177,459 )
2010	2010	Harvard Clinical Research Institution	930 Commonwealth Ave	BOSTON	MA	02215	SUFFOLK	USA	Recovery Act – Comparative Effectiveness Research - AHRQ	000	1	9/28/2010	NEW	$7,177,459
														Subtotal = $7,177,459

Grand Total All Awards = $9,315,165

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BELT: BLACKS & EXACERBATIONS ON LABA VS. TIOTROPIUM

Award Number: R01HS019408

ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY

OPDIV: AHRQ

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2010

PERIOD OF PERFORMANCE END DATE: 09/29/2013

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