Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE) - Full Text View

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) Asthma Clinical Research Network
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00200967

Purpose

The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone HFA) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.

Condition	Intervention	Phase
Asthma	Drug: Salmeterol	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

PEF rate (L/Min) [ Time Frame: Measured daily using a hand-held peak flow meter ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

FEV1, P.M. PEF, and PEF variability [ Time Frame: Measured during clinic visits ] [ Designated as safety issue: Yes ]
Ipratropium responsiveness [ Time Frame: Measured during clinic visits ] [ Designated as safety issue: Yes ]
Bronchodilator effect of albuterol and methacholine PC20 [ Time Frame: Measured during clinic visits ] [ Designated as safety issue: Yes ]
Asthma symptoms [ASUI] [ Time Frame: Measured during clinic visits ] [ Designated as safety issue: Yes ]
Asthma symptom-free days [ Time Frame: Measured during clinic visits ] [ Designated as safety issue: No ]
Duration of effect of long-acting beta agonist inhaled on a regular basis [ Time Frame: Measured during clinic visits ] [ Designated as safety issue: Yes ]
Use of "as needed" medication [ Time Frame: Measured during clinic visits ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: Measured during clinic visits ] [ Designated as safety issue: No ]
Asthma control [ Time Frame: Measured during clinic visits ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	84
Study Start Date:	December 2004
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Detailed Description:

BACKGROUND:

The purpose of this study is to compare the effects of a long-acting beta agonist in patients with asthma receiving inhaled corticosteroids who express two distinct polymorphisms of the beta-2 adrenergic receptor.

DESIGN NARRATIVE:

This is a 62-week crossover design where subjects receive the following therapies:

Beclomethasone HFA (240 µg BID) + PRN albuterol: 8-week run-in
Beclomethasone HFA (240 µg BID) + salmeterol (50 µg BID) + PRN ipratropium bromide + PRN albuterol: 18-week treatment period
Beclomethasone HFA (240 µg BID) + PRN albuterol: 8-week run-out
Beclomethasone HFA (240 µg BID) + placebo salmeterol + PRN ipratropium bromide + PRN albuterol: 18-week treatment period
Beclomethasone HFA (240 µg BID) + PRN albuterol: 10-week run-out

The order of treatments received during the two treatment periods is randomized.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, ages 18 and older
Clinical history consistent with asthma
For subjects regularly using inhaled corticosteroids, FEV1 50% of predicted, methacholine PC20 FEV1 16 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol
For subjects not regularly using inhaled corticosteroids, FEV1 40% of predicted, methacholine PC20 FEV1 8 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol
Genotype eligibility (determined during screening)

Exclusion Criteria:

Smoker (total smoking history must be less than 10 pack years)
Significant unstable medical condition other than asthma
History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the past 10 years
Pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200967

Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0130
University of California, San Diego
San Diego, California, United States, 92103
United States, Colorado
National Jewish Medical & Research Center
Denver, Colorado, United States, 80206
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27103
United States, Wisconsin
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792-3244

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Asthma Clinical Research Network

Investigators

Principal Investigator:	Homer Boushey	University of California, San Francisco
Principal Investigator:	Mario Castro	Washington University School of Medicine
Principal Investigator:	Vernon M. Chinchilli, PhD	Pennsylvania State University Hershey Medical Center
Principal Investigator:	Elliot Israel	Brigham and Women's Hospital
Principal Investigator:	Robert Lemanske	University of Wisconsin, Madison
Principal Investigator:	Richard Martin	National Jewish Medical & Research Center
Principal Investigator:	Stephen Peters	Wake Forest University
Principal Investigator:	Stephen Wasserman	University of California, San Diego

More Information

Asthma Clinical Research Network (ACRN) Website This link exits the ClinicalTrials.gov site

Responsible Party:	Pennsylvania State University Hershey Medical Center ( Vernon M. Chinchilli, PhD )
Study ID Numbers:	262, U10 HL074073, U10 HL074204, U10 HL074208, U10 HL074212, U10 HL074218, U10 HL074225, U10 HL074227, U10 HL074231
Study First Received:	September 12, 2005
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00200967
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Anti-Asthmatic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009