N/A
N=88
Pharmacogenetics of b2-Agonists in Asthma.
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00708227 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Log10 PC20 to Methacholine After Visit 2 — 0.54; 0.48; 0.16; 0.53 log10 mg/mL — p=0.27
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log10 PC20 to Methacholine After Visit 2 |
0.54; 0.48; 0.16; 0.53 | 0.27 |
| PRIMARY Log10 PC20 to Methacholine After Visit 3 |
0.75; 0.78; 0.35; 0.75 | 0.15 |
| PRIMARY Log10 PC20 to Methacholine After Visit 4 |
0.73; 0.89; 0.36; 0.70 | 0.06 |
| SECONDARY Bronchodilator Response to Methacholine (PC20) After Visit 2 |
188.5; 196.6; 169.9; 161.4 | — |
| SECONDARY Bronchodilator Response Following Methacholine Challenge at Visit 3 |
183.6; 189.2; 160.0; 157.7 | — |
| SECONDARY Bronchodilator Response Following Methacholine Challenge at Visit 4 |
187.3; 187.1; 163.2; 157.7 | — |
Summary
This study will help to find out if having a certain genetic makeup influences how a person with asthma responds to salmeterol, one of the two drugs in Advair(R).
Eligibility Criteria
Inclusion Criteria
- Diplotype: Whites with specific diplotype and African Americans with specific diplotypes.
- Gender: Male or female. Women are eligible if they are not pregnant or lactating. Females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test.
- Age: 10 years and older.
- Asthma Diagnosis: Physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months.
- Asthma Therapy: There is no requirement for previous asthma therapy to be included in this study.
- Asthma Severity: forced expiratory volume in the first second (FEV1) must be >= 60% of predicted normal values for age, height, and gender.
- methacholine challenge test provocative concentration (20% fall in FEV1) of <=12]mg/ml.
Exclusion Criteria
- History of life-threatening asthma: Any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- Asthma instability: Hospitalization for asthma within 3 months of Visit 1.
- Concurrent respiratory disease: Any respiratory disease other than asthma.
- Sensitivities: Sensitivities to methacholine, Flovent® MDI, ipratropium bromide, albuterol, or Advair Diskus® that would put the safety of the subject at risk.
- Respiratory Tract Infection: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to Visit 1.
- Expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. These patients can be studied when pollen exposure to which they are sensitive will not occur.
Data sourced from ClinicalTrials.gov (NCT00708227). 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.