View Clinical Trial (Medical Research Study)
Pharmacogenetics of b2-Agonists in Asthma.
| City: |
|
Jacksonville |
| State: |
|
Florida |
| Zip Code: |
|
32207 |
| Conditions: |
|
Asthma |
| Purpose: |
|
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).
|
| Study Summary: |
|
Patients are being asked to take part in this research study because they have asthma. This
clinical research study is being done to see if an asthmatic's gene make-up (DNA is made up
of genes) affects the way they respond to a particular asthma medication called salmeterol.
Certain genes make people tall or short. Certain genes give people brown or black hair.
Similarly, certain genes may be associated with the way patients respond to asthma
medications.
Salmeterol xinafoate (a long acting bronchodilator) and fluticasone propionate (an inhaled
corticosteroid) are the medicines contained in Advair Diskus. During this study, patients
with asthma will receive fluticasone inhaler (called Flovent) and Advair Diskus. The
investigators want to find out if patients with asthma with certain genes respond in
different ways to the salmeterol in Advair Diskus. The investigators also want to find out
if patients with asthma with certain genes who are treated with salmeterol for two weeks
have their airways open up less than usual when they use albuterol.
|
| Criteria: |
|
Inclusion Criteria:
- Diplotype: Whites with diplotype AA or BB and African Americans with diplotype BB or
CC.
- 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 MCT.
- Age: 12 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: FEV1 must be >= 60% of predicted normal values for age, height, and
gender.
- MCT PC20 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.
|
| NCT ID: |
|
NCT00708227 |
| Primary Contact: |
|
Principal Investigator
Kathryn Blake, Pharm.D.
Nemours Children's Clinic
Stacey Gray
Phone: (904) 697-3683
Email: slgray@nemours.org
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Jacksonville, Florida 32207
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 22, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|