AsthmaPhase 4NCT00156819
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
A Phase 4 study testing fluticasone, montelukast and Fluticasone plus salmeterol in people with Asthma, run by JHSPH Center for Clinical Trials at 19 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- fluticasone, montelukast and Fluticasone plus salmeterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 19 sitesUnited States
- Study dates
- Jun 2003to Aug 2006
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- physician-diagnosed asthma
- age 6 or older
- pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted
- beta-agonist reversibility OR airways hyperreactivity by methacholine challenge
- Juniper Asthma Control Score of 1.5 or greater if not on daily controller
- good current health
Who cannot join
- current or past smoking (greater than 20 pack-years)
- chronic or current oral steroid therapy
- pregnancy, lack of effective contraception (when appropriate), lactation
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Northern New England Consortium (Univ. of Vermont and other locations)
Burlington, Vermont, 05405
Illinois Consortium (Northwestern, Univ. of Chicago, Univ. of Illinois)
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
National Jewish Hospital
Denver, Colorado, 80206
Duke University School of Medicine
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Nemour's Childrens Center
Jacksonville, Florida, 32207
University of Missouri at Kansas City
Kansas City, Missouri, 64108
University of Miami (and University of South Florida in Tampa)
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Long Island Jewish Hospital (and North Shore Hospital)
New Hyde Park, New York, 11040
Louisiana State University
New Orleans, Louisiana, 70112
New York Consortium (New York Univ. and Columbia Univ.)
New York, New York, 10016
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, 19107
Washington University
St Louis, Missouri, 63110
New York Medical College
Valhalla, New York, 10595
About this study
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.
Read the detailed description
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).
- Conditions
- Asthma
- Being tested
- fluticasone, montelukast, Fluticasone plus salmeterol
- Keywords
- Asthma, Asthma Control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasoneDrug
fluticasone (100 microgram twice daily) treatment
montelukastDrug
Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterolDrug
fluticasone (100 microgram) plus salmeterol (50 microgram) each night
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone | Active comparator | Participants continued fluticasone (100 microgram twice daily) treatment. Receives: Drug: fluticasone; Drug: montelukast; Drug: Fluticasone plus salmeterol |
| Montelukast | Experimental | Participants were changed to Montelukast (5 or 10 mg each night). Receives: Drug: fluticasone; Drug: montelukast; Drug: Fluticasone plus salmeterol |
| Fluticasone plus salmeterol | Experimental | Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night. Receives: Drug: fluticasone; Drug: montelukast; Drug: Fluticasone plus salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionAug 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- JHSPH Center for Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Nicholas Anthonisen, MD, Study chair, University of Winnipeg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156819
- Sponsor's protocol ID
- ALAACRC-03
- Status last verified
- Nov 2015
- First submitted
- 8 Sep 2005
- Last updated
- 9 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 39497092Sharma 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.
PubMed 37461659Lang 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.
PubMed 21799027Duan 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.
PubMed 20851928American 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.
PubMed 17507702
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
- ClinicalTrials.gov ID
- NCT00156819
- Acronym / sponsor ID
- ALAACRC-03
- Conditions
- Asthma
- Keywords
- Asthma, Asthma Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- JHSPH Center for Clinical TrialsUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 9 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluticasone | Active comparator | Drug: fluticasone, Drug: montelukast, Drug: Fluticasone plus salmeterolParticipants continued fluticasone (100 microgram twice daily) treatment. |
| Montelukast | Experimental | Drug: fluticasone, Drug: montelukast, Drug: Fluticasone plus salmeterolParticipants were changed to Montelukast (5 or 10 mg each night). |
| Fluticasone plus salmeterol | Experimental | Drug: fluticasone, Drug: montelukast, Drug: Fluticasone plus salmeterolParticipants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- physician-diagnosed asthma
- age 6 or older
- pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted
- beta-agonist reversibility OR airways hyperreactivity by methacholine challenge
- Juniper Asthma Control Score of 1.5 or greater if not on daily controller
Key exclusion criteria (3 listed)
- current or past smoking (greater than 20 pack-years)
- chronic or current oral steroid therapy
- pregnancy, lack of effective contraception (when appropriate), lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluticasonefluticasone (100 microgram twice daily) treatment | Drug | Fluticasone, Fluticasone plus salmeterol, Montelukast |
| montelukastMontelukast (5 or 10 mg each night). | Drug | Fluticasone, Fluticasone plus salmeterol, Montelukast |
| Fluticasone plus salmeterolfluticasone (100 microgram) plus salmeterol (50 microgram) each night | Drug | Fluticasone, Fluticasone plus salmeterol, Montelukast |
Primary outcome
Treatment Failure
Time frame: 16 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39497092Sharma 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.
- Derived from this study: PubMed 37461659Sharma 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.
- Derived from this study: PubMed 21799027Lang 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.
- Derived from this study: PubMed 20851928Duan 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.
- Derived from this study: PubMed 17507702American 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.
- American Lung Association Asthma Clinical Research CentersLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Anthonisen, MD study chair
University of Winnipeg
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluticasone, montelukast and Fluticasone plus salmeterol in people with Asthma, run by JHSPH Center for Clinical Trials at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00156819, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.