Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.
This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of controller therapy without loss of asthma control. Patients demonstrating good control on twice-daily low-dose ICS will be randomized to one of three treatment groups: once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or once-daily combination therapy (fluticasone-salmeterol).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone | Active Comparator | Participants continued fluticasone (100 microgram twice daily) treatment. |
|
| Montelukast | Experimental | Participants were changed to Montelukast (5 or 10 mg each night). |
|
| Fluticasone plus salmeterol | Experimental | Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone | Drug | fluticasone (100 microgram twice daily) treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failure | The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety. | 16 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicholas Anthonisen, MD | University of Winnipeg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| National Jewish Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39497092 | Derived | Sharma R, Tiwari A, Kho AT, Wang AL, Srivastava U, Piparia S, Desai B, Wong R, Celedon JC, Peters SP, Smith LJ, Irvin CG, Castro M, Weiss ST, Tantisira KG, McGeachie MJ. Circulating microRNAs associated with bronchodilator response in childhood asthma. BMC Pulm Med. 2024 Nov 4;24(1):553. doi: 10.1186/s12890-024-03372-4. | |
| 37461659 |
| Label | URL |
|---|---|
| American Lung Association Asthma Clinical Research Centers | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone | Participants continued fluticasone (100 microgram twice daily) treatment. fluticasone: fluticasone (100 microgram twice daily) treatment montelukast: Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| montelukast | Drug | Montelukast (5 or 10 mg each night). |
|
| Fluticasone plus salmeterol | Drug | fluticasone (100 microgram) plus salmeterol (50 microgram) each night |
|
| Denver |
| Colorado |
| 80206 |
| United States |
| Nemour's Childrens Center | Jacksonville | Florida | 32207 | United States |
| University of Miami (and University of South Florida in Tampa) | Miami | Florida | 33136 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois) | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Louisiana State University | New Orleans | Louisiana | 70112 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Missouri at Kansas City | Kansas City | Missouri | 64108 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Long Island Jewish Hospital (and North Shore Hospital) | New Hyde Park | New York | 11040 | United States |
| New York Consortium (New York Univ. and Columbia Univ.) | New York | New York | 10016 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27710 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Northern New England Consortium (Univ. of Vermont and other locations) | Burlington | Vermont | 05405 | United States |
| Sharma R, Tiwari A, Kho AT, Wang AL, Srivastava U, Piparia S, Desai B, Wong R, Celedon JC, Peters SP, Smith LJ, Irvin CG, Castro M, Weiss ST, Tantisira KG, McGeachie MJ. Circulating MicroRNAs associated with Bronchodilator Response in Childhood Asthma. Res Sq [Preprint]. 2023 Jun 29:rs.3.rs-3101724. doi: 10.21203/rs.3.rs-3101724/v1. |
| 21799027 | Derived | Lang JE, Hossain J, Dixon AE, Shade D, Wise RA, Peters SP, Lima JJ; American Lung Association-Asthma Clinical Research Centers. Does age impact the obese asthma phenotype? Longitudinal asthma control, airway function, and airflow perception among mild persistent asthmatics. Chest. 2011 Dec;140(6):1524-1533. doi: 10.1378/chest.11-0675. Epub 2011 Jul 28. |
| 20851928 | Derived | Duan QL, Gaume BR, Hawkins GA, Himes BE, Bleecker ER, Klanderman B, Irvin CG, Peters SP, Meyers DA, Hanrahan JP, Lima JJ, Litonjua AA, Tantisira KG, Liggett SB. Regulatory haplotypes in ARG1 are associated with altered bronchodilator response. Am J Respir Crit Care Med. 2011 Feb 15;183(4):449-54. doi: 10.1164/rccm.201005-0758OC. Epub 2010 Sep 17. |
| 17507702 | Derived | American Lung Association Asthma Clinical Research Centers; Peters SP, Anthonisen N, Castro M, Holbrook JT, Irvin CG, Smith LJ, Wise RA. Randomized comparison of strategies for reducing treatment in mild persistent asthma. N Engl J Med. 2007 May 17;356(20):2027-39. doi: 10.1056/NEJMoa070013. |
| Montelukast |
Participants were changed to Montelukast (5 or 10 mg each night). fluticasone: fluticasone (100 microgram twice daily) treatment montelukast: Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night |
| FG002 | Fluticasone Plus Salmeterol | Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night. fluticasone: fluticasone (100 microgram twice daily) treatment montelukast: Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone | Participants continued fluticasone (100 microgram twice daily) treatment. fluticasone: fluticasone (100 microgram twice daily) treatment montelukast: Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night |
| BG001 | Montelukast | Participants were changed to Montelukast (5 or 10 mg each night). fluticasone: fluticasone (100 microgram twice daily) treatment montelukast: Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night |
| BG002 | Fluticasone Plus Salmeterol | Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night. fluticasone: fluticasone (100 microgram twice daily) treatment montelukast: Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Treatment Failure | The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety. | Posted | Number | participants | 16 weeks |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluticasone | Participants continued fluticasone (100 microgram twice daily) treatment. fluticasone: fluticasone (100 microgram twice daily) treatment montelukast: Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night | 6 | 168 | 159 | 168 | ||
| EG001 | Montelukast | Participants were changed to Montelukast (5 or 10 mg each night). fluticasone: fluticasone (100 microgram twice daily) treatment montelukast: Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night | 4 | 165 | 156 | 165 | ||
| EG002 | Fluticasone Plus Salmeterol | Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night. fluticasone: fluticasone (100 microgram twice daily) treatment montelukast: Montelukast (5 or 10 mg each night). Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night | 4 | 162 | 157 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment | Suffered concussion while snowboarding. |
| |
| Chest pain | Cardiac disorders | Non-systematic Assessment |
| ||
| Partial right knee replacement surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Drop in peak flow | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Anaphylactic reaction to peanuts | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Allergic reaction to Bactim | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Elbow sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Abcess | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tonsilectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hoarsness/ dysphonia | General disorders | Systematic Assessment |
| ||
| Sinisitis | Infections and infestations | Systematic Assessment |
| ||
| Nasal congestion | General disorders | Systematic Assessment |
| ||
| Viral respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Diarrhea | General disorders | Systematic Assessment |
| ||
| Nausea and vomitting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal distress | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | Infections and infestations | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Razan Yasin | Johns Hopkins Center for Clinical Trials | 443-287-5796 | ryasin1@jhu.edu |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| C093875 | montelukast |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Male |
|