Phase 3
Completed N=87
Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)
Source: ClinicalTrials.gov NCT00200967 ↗Enrolled (actual)
87
Serious AEs
5.8%
Results posted
Jun 2009
Primary outcomePrimary: Morning (AM) Peak Expiratory Flow (PEF) Rate — -21; -22 liters per minute — p=0.99
Summary
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 hydroflouroalkane (HFA) inhaler) 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morning (AM) Peak Expiratory Flow (PEF) Rate |
-21; -22 | 0.99 |
| SECONDARY Evening (PM) Peak Expiratory Flow (PEF) Rate |
-25; -24 | 0.82 |
| SECONDARY Peak Expiratory Flow (PEF) Variability |
0.2; 0.7 | 0.31 |
| SECONDARY Asthma Symptoms |
0.04; 0.00 | 0.09 |
| SECONDARY Rescue Medication (Ipratropium and Albuterol) Use |
0.2; 0.0 | 0.25 |
| SECONDARY Spirometry Forced Expiratory Volume in One Second (FEV1), Pre-bronchodilator |
-0.08; -0.04 | 0.34 |
| SECONDARY Spirometry Forced Vital Capacity (FVC), Pre-bronchodilator |
-0.04; -0.03 | 0.91 |
| SECONDARY Spirometry Peak Expiratory Flow (PEF) Rate, Pre-bronchodilator |
-17; -17 | 0.93 |
| SECONDARY Exhaled Nitric Oxide (eNO) |
0.12; -0.02 | 0.13 |
| SECONDARY Exhaled Breath Condensate (EBC) |
-0.10; -0.03 | 0.79 |
| SECONDARY Methacholine Provocative Concentration 20 (PC20) |
0.06; -1.27 | 0.004 sig |
| SECONDARY Asthma Control Questionnaire (ACQ) |
0.13; 0.11 | 0.89 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00200967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.