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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL081245 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Florida | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whites ADRB2:ARG16ARG | 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. | ||
| Whites ADRB2:GLY16GLY | 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. | ||
| African American ADRB2:ARG16ARG | 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. | ||
| African American ADRB2:GLY16GLY | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Log10 PC20 to Methacholine After Visit 2 | Visit 2 log10 PC20 after receiving 2 weeks of Flovent | Visit 2:12 hours after last dose of Flovent |
| Log10 PC20 to Methacholine After Visit 3 | Visit 3 Log10 PC20 after receiving 2 weeks of Advair | Visit 3:12 hours after the last dose of Advair |
| Log10 PC20 to Methacholine After Visit 4 | Visit 4 log10 PC20 to Methacholine after stopping Advair | 36 hours after the last dose of Advair |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchodilator Response to Methacholine (PC20) After Visit 2 | 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 next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Flovent for 2 weeks at Visit 2. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Blake, Pharm.D. | Nemours Children's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23384627 | Result | 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. |
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Enrolled participants were excluded from receiving planned study treatment if they did not meet the ADRB2 genotype criteria and if they did not have a methacholine PC20 of 12.5mg/ml or less.
Participants were recruited from Nemours Children's Health System, the University of Florida Jacksonville, health fairs and events, Edward Waters College, and from previous study participation. Participants were recruited between January 2008 and October 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Whites ADRB2:ARG16ARG | 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. fluticasone: 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 |
| FG001 | Whites ADRb2:GLY16GLY | 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. Salmeterol: 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 |
| FG002 | African Americans ADRB2:ARG16ARG | 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. Salmeterol: 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 |
| FG003 | African Americans ADRB2:GLY16GlY | 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. Salmeterol: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Whites ADRB2:ARG16ARG | All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy. fluticasone: 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Log10 PC20 to Methacholine After Visit 2 | Visit 2 log10 PC20 after receiving 2 weeks of Flovent | All participants who had a methacholine challenge at Visit 2. All participants had received Flovent for 2 weeks. | Posted | Mean | Standard Deviation | log10 mg/mL | Visit 2:12 hours after last dose of Flovent |
|
Adverse event data were collected during the study period from Visit 1 through Visit 4 (approximately 4 weeks total follow-up).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Whites ADRB2:ARG16ARG | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant developed worsening asthma after methacholine challenge at Visit 2. The PCP started the participant on prednisone and oxygen. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Blake | Nemours Children's Specialty Care | 9046973806 | kathryn.blake@nemours.org |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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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:
| 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent. |
| Bronchodilator Response Following Methacholine Challenge at Visit 3 | 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 next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Advair for 2 weeks at Visit 3. | 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair |
| Bronchodilator Response Following Methacholine Challenge at Visit 4 | 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 next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had discontinued Advair for 36 hours. | 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair |
| Withdrawal by Subject |
|
| BG001 | Whites ADRB2:GLY16GLY | All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy. Salmeterol: 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 |
| BG002 | African Americans ADRB2:ARG16ARG | All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy. fluticasone: 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 |
| BG003 | African Americans ADRB2:GLY16GLY | All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy. fluticasone: 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| ADRB2 Genotype at Codon 16 | Count of Participants | Participants |
|
| OG002 | African Americans ADRB2:ARG16ARG | Log10 methacholine PC20 data in African Americans with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Flovent. |
| OG003 | African Americans ADRB2:GLY16GLY | Log10 methacholine PC20 data in African Americans with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Flovent. |
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| Primary | Log10 PC20 to Methacholine After Visit 3 | Visit 3 Log10 PC20 after receiving 2 weeks of Advair | All participants who had a methacholine challenge at Visit 3. All participants had received Advair for 2 weeks. | Posted | Mean | Standard Deviation | log10 mg/mL | Visit 3:12 hours after the last dose of Advair |
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|
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| Primary | Log10 PC20 to Methacholine After Visit 4 | Visit 4 log10 PC20 to Methacholine after stopping Advair | All participants who had a methacholine challenge at Visit 4. All participants had discontinued Advair for 36 hours. | Posted | Mean | Standard Deviation | log10 mg/mL | 36 hours after the last dose of Advair |
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|
|
| Secondary | Bronchodilator Response to Methacholine (PC20) After Visit 2 | 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 next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Flovent for 2 weeks at Visit 2. | All participants who had received Flovent for 2 weeks at Visit 2. | Posted | Mean | Standard Deviation | Liters*min | 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent. |
|
|
|
| Secondary | Bronchodilator Response Following Methacholine Challenge at Visit 3 | 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 next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Advair for 2 weeks at Visit 3. | 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. Participants had received Advair for 2 weeks at Visit 3. | Posted | Mean | Standard Deviation | Liters*min | 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair |
|
|
|
| Secondary | Bronchodilator Response Following Methacholine Challenge at Visit 4 | 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 next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had discontinued Advair for 36 hours. | 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. Participants had received Advair for 2 weeks at Visit 3. | Posted | Mean | Standard Deviation | Liters*min | 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair |
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|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Whites ADRB2:GLY16GLY | 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. | 0 | 26 | 0 | 26 | 1 | 26 |
| EG002 | African American ADRB2:ARG16ARG | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG003 | African American ADRB2:GLY16GLY | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |