Expired Study
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Jacksonville, Florida 32207


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 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.


Study is Available At:


Original ID:

82211


NCT ID:

NCT00708227


Secondary ID:

K23HL081245


Study Acronym:


Brief Title:

Pharmacogenetics of b2-Agonists in Asthma.


Official Title:

Pharmacogenetics of b2-Agonists in Asthma.


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

10 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nemours Children's Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

88


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kathryn Blake, Pharm.D.
Principal Investigator
Nemours Children's Clinic

Study Dates

Start Date:September 2007
Completion Date:August 2012
Completion Type:Actual
Primary Completion Date:August 2012
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 20, 2018
First Received Date:June 27, 2008
First Results Date:December 20, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Bronchodilator Response Following Methacholine Challenge at Visit 4
Time Frame:0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes a
Safety Issues:False
Description:The area under the curve (AUC) bronchodilator response after Visit 4 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the
Outcome Type:Secondary Outcome
Measure:Bronchodilator Response Following Methacholine Challenge at Visit 3
Time Frame:0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes a
Safety Issues:False
Description:The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the
Outcome Type:Secondary Outcome
Measure:Bronchodilator Response to Methacholine (PC20) After Visit 2
Time Frame:0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes a
Safety Issues:False
Description:The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the
Outcome Type:Primary Outcome
Measure:Log10 PC20 to Methacholine After Visit 4
Time Frame:36 hours after the last dose of Advair
Safety Issues:False
Description:Visit 4 log10 PC20 to Methacholine after stopping Advair
Outcome Type:Primary Outcome
Measure:Log10 PC20 to Methacholine After Visit 3
Time Frame:Visit 3:12 hours after the last dose of Advair
Safety Issues:False
Description:Visit 3 Log10 PC20 after receiving 2 weeks of Advair
Outcome Type:Primary Outcome
Measure:Log10 PC20 to Methacholine After Visit 2
Time Frame:Visit 2:12 hours after last dose of Flovent
Safety Issues:False
Description:Visit 2 log10 PC20 after receiving 2 weeks of Flovent

Study Interventions

Intervention Type:Drug
Name:fluticasone
Description:Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief
Arm Name:Fluticasone
Other Name:fluticasone propionate (Flovent Diskus)
Intervention Type:Drug
Name:Salmeterol
Description:Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief
Arm Name:Salmeterol
Other Name:Advair (fluticasone propionate and salmeterol xino
Intervention Type:Drug
Name:Ipratropium bromide
Description:Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief
Arm Name:Ipratropium bromide
Other Name:Atrovent (ipratropium bromide)

Study Arms

Study Arm Type:Other
Arm Name:African American ADRB2:GLY16GLY
Description:All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
Study Arm Type:Other
Arm Name:African American ADRB2:ARG16ARG
Description:All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
Study Arm Type:Other
Arm Name:Whites ADRB2:GLY16GLY
Description:All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
Study Arm Type:Other
Arm Name:Whites ADRB2:ARG16ARG
Description:All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Nemours Children's Clinic
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Florida

Samples and Retentions

Sample Retention:Samples With DNA
Description: The purpose of the epigenetic substudy is to collecting blood is for exploratory research into epigenetic effects of salmeterol therapy. Blood was collected at Visit 2 and Visit 3. Steps: - Obtain informed consent - Label vacutainer tube with patient's study ID number, visit number, date of collection (use a sharpee pen) - Collect 10mL blood sample into purple top tube before starting methacholine challenge (must be done before any albuterol is given at the visit) - Immediately place tube in crushed ice or in refrigerator - Spin tube; freeze tube with cells for future genotyping/methylation studies; divide plasma as equally as possible between the 3 cryotubes, freeze the EDTA tube and 3 cryotubes.
Study Population: The study population was Whites and African Americans with specific ADRB2 diplotypes aged 10 years or older with physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months, forced expiratory volume in the first second (FEV1) >= 60% of predicted normal values for age, height, and gender, and a methacholine challenge test provocative concentration (20% fall in FEV1) of <=12]mg/ml.
Sample Method:Non-Probability Sample

Study References

Reference Type:Results Reference
Citation:Blake K, Cury JD, Hossain J, Tantisira K, Wang J, Mougey E, Lima J. Methacholine PC20 in African Americans and whites with asthma with homozygous genotypes at ADRB2 codon 16. Pulm Pharmacol Ther. 2013 Jun;26(3):342-7. doi: 10.1016/j.pupt.2013.01.009. Epub 2013 Feb 4.
PMID:23384627

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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