Official Title: “Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment

Study Primary Completion Date: March 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Salmeterol

Primary Measures

• PEF rate (L/Min)
  • Time Frame: Measured daily using a hand-held peak flow meter
    Safety Issue?: Yes

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

Homer Boushey Principal Investigator University of California, San Francisco  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00200967

Study ID Number: 262

ClinicalTrials.gov Identifier: NCT00200967

Health Authority: United States: Federal Government

Asthma Clinical Research Network (ACRN) Website