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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| St. Louis University | OTHER |
| Long Island Jewish Medical Center | OTHER |
| North Shore University Hospital |
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The purpose of this research is to evaluate the methacholine challenge test as an accurate indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares methacholine challenge test results from asthma patients to those from people who do not have asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid will be compared to results on high dose inhaled corticosteroids. Both males and females with stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will be between 12 and 69 years of age.
The study consists of two phases. The first phase is a cross-sectional, case-control study measuring the sensitivity and specificity of methacholine challenge testing for differentiating asthmatic participants from non-asthmatic controls. The second phase is a cross-over, randomized, double-masked trial designed to evaluate the impact of high dose versus low dose inhaled corticosteroids (ICS) on bronchial hyperreactivity (BHR) in asthmatics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose fluticasone for phase 2 | Active Comparator | For people with asthma, fluticasone at 250 mcg per day; phase 2 of study |
|
| High dose fluticasone for phase 2 | Active Comparator | For people with asthma, fluticasone at 1000 mcg per day; phase 2 of study |
|
| Nonasthmatic controls for phase 1 | No Intervention | People without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study | |
| Asthmatic controls for phase 1 | No Intervention | People with asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone | Drug | Inhaled corticosteroid approved for treatment of asthma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Methacholine Challenge Test Result for Phase 2 | Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks | weeks 0, 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive Value of Methacholine Challenge Test for Phase 1 | Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls | one time |
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Asthmatic participants
Inclusion Criteria:
Exclusion Criteria:
Nonasthmatic control criteria:
Inclusion Criteria:
Exclusion Criteria:
A subject will be excluded if there is a history within the previous 5 years of:
Respiratory tract infection within past 4 weeks
History of cigarette smoking within the past 5 years or >10 pack years total
Known allergy to methacholine (for example, a previous bad reaction to methacholine) or to any other parasympathomimetic agents
Current use of beta adrenergic blocking agent (a heart medicine) or a cholinesterase inhibitor (medicine used to treat myasthenia gravis or Alzheimer's disease).
History of epilepsy, cardiovascular disease with bradycardia (slow heart beat), vagotonia (increased activity of the vagus nerve causing slow heart rate or low blood pressure), peptic ulcer disease, thyroid disease, or urinary tract obstruction
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| Name | Affiliation | Role |
|---|---|---|
| Kaharu Sumino, MD | St. Louis Asthma Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Diego | San Diego | California | 92103 | United States | ||
| The Nemours Children's Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22465214 | Derived | Sumino K, Sugar EA, Irvin CG, Kaminsky DA, Shade D, Wei CY, Holbrook JT, Wise RA, Castro M; American Lung Association Asthma Clinical Research Centers. Methacholine challenge test: diagnostic characteristics in asthmatic patients receiving controller medications. J Allergy Clin Immunol. 2012 Jul;130(1):69-75.e6. doi: 10.1016/j.jaci.2012.02.025. Epub 2012 Apr 1. |
| Label | URL |
|---|---|
| Asthma Clinical Research Centers website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asthmatic Controls for Phase 1 | People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1. |
| FG001 | Non Asthmatic Controls for Phase 1 | People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1. |
| FG002 | Low Dose, Then High Dose Fluticasone for Phase 2 | People with asthma receive fluticasone at 250 mcg per day (28 days), then wash-out period (28 days), then fluticasone at 1000 mcg per day (28 days) in phase 2. |
| FG003 | High Dose, Then Low Dose Fluticasone for Phase 2 | People with asthma receive fluticasone at 1000 mcg per day 28 days), then wash-out period (28 days), fluticasone at 250 mcg per day (28 days) in phase 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1:Control Challenge |
| |||||||||||||
| Phase 2: Trial |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nonasthmatic Controls for Phase 1 | People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1. |
| BG001 | Asthmatic Controls for Phase 1 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Methacholine Challenge Test Result for Phase 2 | Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks | There was a significant period effect in the percentage change in post diluent baseline (PC20) for high- and low-dose depending upon the order in which the doses were administered. In order to remove the effect of the order, we compared the high- and low-dose MCT results exclusively during the first cross over. | Posted | Geometric Mean | Full Range | mg/ml | weeks 0, 4 |
|
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Adverse events were not collected in phase 1 of the study
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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 | Low Dose for phase1 | 4 weeks of Fluticasone (Flovent diskus) 250 mcg twice daily (500 mcg/day) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Capser | Johns Hopkins University | 410-955-8183 | ashankli@jhsph.edu |
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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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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| OTHER |
| Baylor College of Medicine | OTHER |
| University of Vermont | OTHER |
| Nemours Children's Clinic | OTHER |
| University of Florida | OTHER |
| Indiana University | OTHER |
| Ohio State University | OTHER |
| NYU Langone Health | OTHER |
| University of Missouri-Columbia | OTHER |
| Northwestern University | OTHER |
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
| University of Miami | OTHER |
| University of South Florida | OTHER |
| University of California, San Diego | OTHER |
| National Jewish Health | OTHER |
| Duke University | OTHER |
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| Jacksonville |
| Florida |
| 32207 |
| United States |
| University of Miami/Univestiy of South Florida | Miami | Florida | 33136 | United States |
| Northwestern University Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Louisianna State University | New Orleans | Louisiana | 70112 | United States |
| University of Missouri-Kansas City | Kansas City | Missouri | 64108 | United States |
| Washington University School of Medicine | St Louis | Missouri | 631110 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| New York Consortium/Columbia University | New York | New York | 10016 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Vermont Lung Center at the University of Vermont | Burlington | Vermont | 05405 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 4 Weeks of Low Dose Fluticasone | 4 weeks of Fluticasone (Flovent diskus) 250 mcg once daily |
|
|
|
| Secondary | Predictive Value of Methacholine Challenge Test for Phase 1 | Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls | Posted | Number | 95% Confidence Interval | % predictive value | one time |
|
|
|
| 0 |
| 30 |
| 23 |
| 30 |
| EG001 | High Dose for Phase 2 | 4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day) | 0 | 32 | 22 | 32 |
| Oral candidiasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | General disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hoarseness/ dysphoria | General disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Upper respiratory inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Viral lower respiratory infection | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gastrointestinal discomfort and pain | Gastrointestinal disorders | Systematic Assessment |
|
| Viral gastrointestinal infection | Infections and infestations | Systematic Assessment |
|
| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |