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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled glucocorticosteroid improves disease control in persistent asthma. This observation has supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination preparations for the management of asthma. Currently, salmeterol/fluticasone and formoterol/budesonide are available for clinical use. The long-term beneficial clinical effects of the two drug classes seem to be synergistic, and several mechanisms of glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been invoked to explain this phenomenon.This study, wish to address the question whether glucocorticoids can acutely potentiate the bronchodilator response to a long-acting beta-adrenergic agonist.We expect that in patients with asthma, the short-term bronchodilator effect of salmeterol is enhanced by the addition of fluticasone, which by itself has no short-term bronchodilator effect. To test this premise, we will assess the respective short-term effects of salmeterol (50 µg), fluticasone (250 µg), salmeterol/fluticasone (50/250 µg), and placebo/placebo on spirometric parameters. Airway Blood flow will also be measured to ensure that vasoconstriction does not occur.
Fourteen lifetime nonsmokers with a physician diagnosis of asthma will be recruited for the study. All subjects will be allowed to use short-acting beta-adrenergic agonists as rescue medication.
Inclusion criteria:
Exclusion criteria:
2. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluticasone/salmeterol | Experimental | participants were treated fluticasone/salmeterol, |
|
| salmeterol | Experimental | participants were treated with salmeterol |
|
| fluticasone | Experimental | participants were treated with fluticasone |
|
| placebo inhalation | Placebo Comparator | participants were treated with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone | Drug | 220- mcg once |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Change From Baseline in Airway Blood Flow (Qaw) | maximum change in Qaw within 240 minutes post drug inhalation |
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Inclusion Criteria:
Exclusion Criteria:
1. Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. 2. Cardiovascular disease and/or use of cardiovascular medications 3. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above
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| Name | Affiliation | Role |
|---|---|---|
| Adam Wanner, MD | University of Miami | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21980058 | Derived | Mendes ES, Rebolledo P, Wanner A. Acute effects of salmeterol and fluticasone propionate alone and in combination on airway blood flow in patients with asthma. Chest. 2012 May;141(5):1184-1189. doi: 10.1378/chest.11-0685. Epub 2011 Oct 6. |
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Subjects were recruited from our Asthma Database. Subjects with asthma who are in our database have previously agreed to serve as potential subjects in future studies. These subjects have signed an informed consent (approved by UM IRB) to be included in this database.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Groups | inhalation of 250 mcg of fluticasone fluticasone: 220- mcg once |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Fourteen lifetime nonsmokers with a physician diagnosis of asthma were recruited for the study. All but one of the subjects were using an ICS/LABA combination preparation regularly, and all used a short-acting b2-adrenergic agonist as rescue medication. All subjects had to have a prebronchodilator FEV1 of 60% to 85% predicted .
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | participant received in random order one of the four treatments ( fluticasone, salmeterol, fluticasone+salmeterol or placebo) |
| 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 | Maximum Change From Baseline in Airway Blood Flow (Qaw) | Posted | Mean | Standard Error | change from baseline ( µl/min/ml) | maximum change in Qaw within 240 minutes post drug inhalation |
|
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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 | Fluticasone | inhalation of 250 mcg of fluticasone fluticasone: 220- mcg once |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Wanner, MD | University of Miami | (305)243-2568 | awanner@med.miami.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 |
| D000073893 | Sugars |
| D000068299 | Salmeterol Xinafoate |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| placebo inhalation |
| Drug |
placebo inhalation once |
|
|
| Salmeterol | Drug | 50 mcg salmeterol once |
|
|
| fluticasone/salmeterol | Drug | inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Airway blood flow (Qaw) | Qaw was measured with a previously validated soluble inert gas uptake method. It is based on quantifying the disappearance of the soluble gas dimethylether (DME) from the anatomical dead space. The method involves the inhalation of a gas mixture containing 10 % DME and 90% nitrogen from 500 ml below the total lung capacity position to total lung capacity, followed by a breathhold (5 or 15 sec) and subsequent exhalation while the instantaneous concentrations of DME and nitrogen are recorded. | Mean | Standard Deviation | µl.min-1.ml-1 |
|
| OG003 | Fluticasone/Salmeterol | inhalation of fluticasone 250mcg combined with salmeterol 50 mcg fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo | inhalation of placebo diskus placebo inhalation: placebo inhalation once | 0 | 14 | 0 | 14 |
| EG002 | Salmeterol | inhalation of salmeterol 50 mcg once Salmeterol: 50 mcg salmeterol once Salmeterol: 50 mcg once | 0 | 14 | 0 | 14 |
| EG003 | Fluticasone/Salmeterol | inhalation of fluticasone 250mcg combined with salmeterol 50 mcg fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol | 0 | 14 | 0 | 14 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |