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The investigators are conducting a study of asthma patients who use fluticasone with salmeterol (Advair) or any other combination of an inhaled corticosteroid (ICS) and a long acting beta agonist (LABA) to manage their asthma symptoms.
Participants begin the study by continuing to use fluticasone with salmeterol or substituting fluticasone with salmeterol for their current ICS/LABA medication at their regular dose or the comparable dose(all study medications are provided) for a six-week period. Patients are then separated into 2 groups: one group is asked to use fluticasone (Flovent), the other to use fluticasone with salmeterol , twice daily over a 16-week period (patients will need to be seen monthly during this time). Neither study personnel nor patients will know which drug is being used.
Patients are also asked to use a peak flow meter and record their daily results on a form, along with the number of puffs they use of their rescue inhaler each day. They also record any changes in asthma medications and information on any asthma episodes.
The investigators hypothesize that there are certain patients with asthma who will do better when a long acting beta agonist is removed from their maintenance asthma medications.
Beta 2 (b2) agonists are the most common type of bronchodilator used to treat asthma. Beta 2 (b2) agonists are agents that bind to b2 receptors and cause muscle relaxation of the airways. There are different variants of the gene (genotypes) that influence how b2 agonists perform among the population.
A recent study demonstrated that patients with mild asthma and the Arg/Arg variant at the 16th amino acid position have improved lung function and asthma control when albuterol (Proventil-HFA), a short acting b2 agonist, is replaced with a different class of bronchodilator. The investigators plan to study asthma patients with distinct genetic makeups of the b2 receptor; specifically Arg/Arg and Gly/Gly.
Throughout the treatment period, patients will be instructed to use ipratropium bromide (Atrovent-HFA), a bronchodilator which works through a different mechanism for rescue therapy; albuterol will be available for use if necessary.
The goal of this study is to determine if the withdrawal of a beta 2 agonist leads to improved asthma control in those asthmatic patients with the Arg/Arg genotype compared with those with the Gly/Gly genotype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arg/Arg genotype on Advair (Fluticasone with Salmeterol) HFA | Active Comparator | Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. |
|
| Gly/Gly genotype on Advair (Fluticasone with Salmeterol) HFA | Active Comparator | Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. |
|
| Arg/Arg genotype on Fluticasone HFA | Experimental | Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone. |
|
| Gly/Gly genotype on Fluticasone HFA | Experimental | Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone with salmeterol | Drug | Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Morning Peak Flow | Absolute change in morning peak flow at the end of the 16-week study period compared with baseline (last two weeks of run-in). Peak flow measurement is a test to measure air flowing out of the lung. | Up to 16 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator | Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator as measured by spirometry | Up to 16 weeks from baseline |
| Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjorie Slankard, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States | ||
| Columbia University Medical Center Eastside |
90 participants enrolled (40 Arg/Arg Genotype and 50 Gly/Gly Genotype). Nine Arg/Arg participants and 14 Gly/Gly participants were not randomized due to dropout or ineligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA | Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups |
| FG001 | Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA | Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups |
| FG002 | Arg/Arg Genotype on Fluticasone HFA | Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone. Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups |
| FG003 | Gly/Gly Genotype on Fluticasone HFA | Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone. Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA | Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. Drug: Fluticasone with salmeterol Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. Other Name: Advair HFA Drug: Ipratropium HFA Primary as-needed rescue medication in all treatment groups Other Name: Atrovent Drug: Albuterol HFA Secondary as-needed rescue medication in all treatment groups |
| 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 | Absolute Change in Morning Peak Flow | Absolute change in morning peak flow at the end of the 16-week study period compared with baseline (last two weeks of run-in). Peak flow measurement is a test to measure air flowing out of the lung. | Posted | Mean | Standard Deviation | L/min | Up to 16 weeks from baseline |
|
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Adverse event data were collected and reported in the groups in which they were analyzed during the 16-week treatment period.
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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 | Arg/Arg Genotype on Advair (Fluticasone With Salmeterol) HFA | Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marjorie Slankard, MD | Columbia University Irving Medical Center | 212-326-8410 | ms53@columbia.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068299 | Salmeterol Xinafoate |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| Fluticasone HFA | Drug | Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. |
|
|
| Ipratropium HFA | Drug | Primary as-needed rescue medication in all treatment groups |
|
|
| Albuterol HFA | Drug | Secondary as-needed rescue medication in all treatment groups |
|
Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator as measured by spirometry |
| Up to 16 weeks from baseline |
| Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator | Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator as measured by spirometry | Up to 16 weeks from baseline |
| Change in Asthma Symptom Score | Asthma symptom score measures asthma symptoms on a scale from 0 to 3. 0 = No asthma symptoms; 1 = 1-3 asthma episodes each lasting 2 hours or less, all mild; 2= 4 or more asthma episodes that interfered with activity, play, school, or sleep for less than 2 hours; 3= 1 or more asthma episodes lasting longer than 2 hours, or resulting in shortening normal activity, or seeing a doctor, or going to a hospital. A higher score indicates a worse outcome. | Up to 16 weeks from baseline |
| New York |
| New York |
| 10022 |
| United States |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | United States |
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG001 | Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA | Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. Drug: Fluticasone with salmeterol Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. Other Name: Advair HFA Drug: Ipratropium HFA Primary as-needed rescue medication in all treatment groups Other Name: Atrovent Drug: Albuterol HFA Secondary as-needed rescue medication in all treatment groups |
| BG002 | Arg/Arg Genotype on Fluticasone HFA | Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone. Drug: Fluticasone HFA Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Other Name: Flovent HFA Drug: Ipratropium HFA Primary as-needed rescue medication in all treatment groups Other Name: Atrovent Drug: Albuterol HFA Secondary as-needed rescue medication in all treatment groups |
| BG003 | Gly/Gly Genotype on Fluticasone HFA | Gly/Gly genotype on Fluticasone HFA Drug: Fluticasone HFA Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Other Name: Flovent HFA Drug: Ipratropium HFA Primary as-needed rescue medication in all treatment groups Other Name: Atrovent Drug: Albuterol HFA Secondary as-needed rescue medication in all treatment groups |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA | Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups |
| OG002 | Arg/Arg Genotype on Fluticasone HFA | Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone. Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups |
| OG003 | Gly/Gly Genotype on Fluticasone HFA | Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone. Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups |
|
|
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator | Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-Bronchodilator as measured by spirometry | Posted | Mean | Standard Deviation | Liter | Up to 16 weeks from baseline |
|
|
|
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator | Change in Forced Expiratory Volume in 1 Second (FEV1) Post-Bronchodilator as measured by spirometry | Posted | Mean | Standard Deviation | Liter | Up to 16 weeks from baseline |
|
|
|
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator | Change in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted Pre-Bronchodilator as measured by spirometry | Posted | Mean | Standard Deviation | Percent Predicted | Up to 16 weeks from baseline |
|
|
|
| Secondary | Change in Asthma Symptom Score | Asthma symptom score measures asthma symptoms on a scale from 0 to 3. 0 = No asthma symptoms; 1 = 1-3 asthma episodes each lasting 2 hours or less, all mild; 2= 4 or more asthma episodes that interfered with activity, play, school, or sleep for less than 2 hours; 3= 1 or more asthma episodes lasting longer than 2 hours, or resulting in shortening normal activity, or seeing a doctor, or going to a hospital. A higher score indicates a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Up to 16 weeks from baseline |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| EG001 | Gly/Gly Genotype on Advair (Fluticasone With Salmeterol) HFA | Asthma patients with the Gly/Gly genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. Fluticasone with salmeterol: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups | 0 | 17 | 0 | 17 | 3 | 17 |
| EG002 | Arg/Arg Genotype on Fluticasone HFA | Asthma patients with the Arg/Arg genotype who are randomized to fluticasone (Flovent HFA) alone. Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups | 0 | 13 | 0 | 13 | 3 | 13 |
| EG003 | Gly/Gly Genotype on Fluticasone HFA | Asthma patients with the Gly/Gly genotype who are randomized to fluticasone (Flovent HFA) alone. Fluticasone HFA: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. Ipratropium HFA: Primary as-needed rescue medication in all treatment groups Albuterol HFA: Secondary as-needed rescue medication in all treatment groups | 0 | 16 | 0 | 16 | 3 | 16 |
| Right Foot Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pharyngitis | General disorders | Systematic Assessment |
|
| Gastric Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Wheeze | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Motor Vehicle Accident | General disorders | Systematic Assessment |
|
| Compressed Cervical Nerve | Nervous system disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |