AsthmaPhase 3BARDNCT01967173

Best African American Response to Asthma Drugs

A Phase 3 study testing Flovent Diskus® 100 mcg, Flovent Diskus® 250 mcg and Flovent Diskus® 500 mcg in people with Asthma, run by Milton S. Hershey Medical Center at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to find the best asthma treatment to add for Blacks who have asthma that is not well controlled on a low dose of inhaled steroid. This study will also try to find out if Black adults and children differ in how they respond to the medications used in this study. Read more about this study

Who is it for?: Ages 5 years and older
Conditions the study is for: Asthma
What is being tested?: Flovent Diskus® 100 mcg, Flovent Diskus® 250 mcg and Flovent Diskus® 500 mcg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 574 participants
Where: 28 sitesUnited States
Study dates: Feb 2014to 1 Jul 2017
Phase: Phase 3
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 5 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Individuals who self-report Black ancestry (with at least 1 Black grandparent).
Able to perform reproducible spirometry according to ATS criteria.
Clinical history consistent with asthma.
Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted.
Asthma confirmed either by: (1) Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR (2) PC20FEV1 ≤ 16 mg/ml OR (3) an absolute relative change in %predicted FEV1 of ≥ 12% over two measurements documented by repeat spirogram over the previous year
Either: A) inadequately controlled on low-, medium- or high-dose ICS monotherapy, or low- or medium-dose ICS/LABA, or B) well-controlled on medium- or high-dose ICS monotherapy, or low-, medium- or high-dose ICS/LABA. Inadequate asthma control will be defined as an ACT/c-ACT score <20; well-controlled asthma will be defined as an ACT/c-ACT score ≥20.

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Stable asthma controller therapy dose (ICS or ICS/LABA) for the 2 weeks prior to enrollment.
Non-smoker (total lifetime smoking history < 5 pack-years if <18, or <10 pack-years if ≥18 years of age; no smoking for at least 1 year).
For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.

Who cannot join

Medical contraindication to LABA or history of adverse reactions to ICS or LABA preparations or any of their ingredients.
Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment.
Unwilling to provide a blood sample for DNA extraction and genetic analysis.
Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study or that would place the participant at increased risk.
Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year.
History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years.

Show all 11Show fewer

History of a respiratory tract infection within 4 weeks of enrollment.
If a female of child-bearing potential, failure to practice abstinence or use an acceptable birth control method.
Pregnancy or lactation or planning to get pregnant during the course of the trial.
Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment.
Participation in an intervention trial or use of investigative drugs in the past 30 days or plans to enroll in such a trial during the study.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30322
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Children's Hospital Boston
Boston, Massachusetts, 02115
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60614
University of Chicago
Chicago, Illinois, 60637
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, 44106
National Jewish Health
Denver, Colorado, 80206
Duke University School of Medicine
Durham, North Carolina, 27110
Nemours Children's Clinic
Jacksonville, Florida, 32207
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Center for Urban Population Health
Milwaukee, Wisconsin, 53223
Columbia University Medical Center
New York, New York, 10032
Children's Hospital & Research Center Oakland
Oakland, California, 94609
Nemours Children's Clinic
Orlando, Florida, 32827
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
North Carolina Clinical Research
Raleigh, North Carolina, 27607
UCSF Benioff Children's Hospital
San Francisco, California, 94143
University of California - San Francisco
San Francisco, California, 94143
St. Louis Children's Hospital
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
University of Arizona College of Medicine
Tucson, Arizona, 85724
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

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About this study

Read the detailed description

BARD is a 66 week prospective, randomized, double-blind, crossover trial in Blacks (individuals who self-report Black ancestry) who have inadequately controlled asthma while taking low-dose inhaled corticosteroids (ICS). BARD will examine the efficacy of increasing the dose of ICS with or without the addition of a long-acting beta agonist (LABA) to determine whether individual patients respond better to one treatment than another and, if so, whether the responses are different for children and adults or if they are related to genetic ancestry.

Conditions: Asthma
Being tested: Flovent Diskus® 100 mcg, Flovent Diskus® 250 mcg, Flovent Diskus® 500 mcg, Advair Diskus® 100/50 mcg, Advair Diskus® 250/50 mcg
Keywords: Asthma, Fluticasone, Salmeterol
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flovent Diskus® 100 mcgDrug
Flovent is an ICS
Flovent Diskus® 250 mcgDrug
Flovent is an ICS
Flovent Diskus® 500 mcgDrug
Flovent is an ICS
Advair Diskus® 100/50 mcgDrug
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcgDrug
Advair is an ICS/LABA combination

Study groups in NCT01967173
Study group	Role	What they receive
Crossover sequence 1	Experimental	Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg Receives: Drug: Flovent Diskus® 100 mcg; Drug: Flovent Diskus® 250 mcg; Drug: Advair Diskus® 100/50 mcg; Drug: Advair Diskus® 250/50 mcg
Crossover sequence 2	Experimental	Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg Receives: Drug: Flovent Diskus® 100 mcg; Drug: Flovent Diskus® 250 mcg; Drug: Advair Diskus® 100/50 mcg; Drug: Advair Diskus® 250/50 mcg
Crossover sequence 3	Experimental	Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Receives: Drug: Flovent Diskus® 100 mcg; Drug: Flovent Diskus® 250 mcg; Drug: Advair Diskus® 100/50 mcg; Drug: Advair Diskus® 250/50 mcg
Crossover sequence 4	Experimental	Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg Receives: Drug: Flovent Diskus® 100 mcg; Drug: Flovent Diskus® 250 mcg; Drug: Advair Diskus® 100/50 mcg; Drug: Advair Diskus® 250/50 mcg
Crossover sequence 5	Experimental	Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg Receives: Drug: Flovent Diskus® 250 mcg; Drug: Flovent Diskus® 500 mcg; Drug: Advair Diskus® 100/50 mcg; Drug: Advair Diskus® 250/50 mcg
Crossover sequence 6	Experimental	Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg Receives: Drug: Flovent Diskus® 250 mcg; Drug: Flovent Diskus® 500 mcg; Drug: Advair Diskus® 100/50 mcg; Drug: Advair Diskus® 250/50 mcg
Crossover sequence 7	Experimental	Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg Receives: Drug: Flovent Diskus® 250 mcg; Drug: Flovent Diskus® 500 mcg; Drug: Advair Diskus® 100/50 mcg; Drug: Advair Diskus® 250/50 mcg
Crossover sequence 8	Experimental	Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg Receives: Drug: Flovent Diskus® 250 mcg; Drug: Flovent Diskus® 500 mcg; Drug: Advair Diskus® 100/50 mcg; Drug: Advair Diskus® 250/50 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen.
This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.
Measured: The last 12 weeks of each 14-week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 20141 Jul 2017

First posted22 Oct 2013 (estimated)
Study startFeb 2014
Primary completion1 Jul 2017
Study completion1 Jul 2017

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 (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 574 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01967173
Sponsor's protocol ID: AsthmaNet 006
Other IDs: 1U10HL098115
Acronym: BARD
Status last verified: Oct 2018
First submitted: 11 Oct 2013
Last updated: 15 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wechsler ME, Szefler SJ, Ortega VE, Pongracic JA, Chinchilli V, Lima JJ, Krishnan JA, Kunselman SJ, Mauger D, Bleecker ER, Bacharier LB, Beigelman A, Benson M, Blake KV, Cabana MD, Cardet JC, Castro M, Chmiel JF, Covar R, Denlinger L, DiMango E, Fitzpatrick AM, Gentile D, Grossman N, Holguin F, Jackson DJ, Kumar H, Kraft M, LaForce CF, Lang J, Lazarus SC, Lemanske RF Jr, Long D, Lugogo N, Martinez F, Meyers DA, Moore WC, Moy J, Naureckas E, Olin JT, Peters SP, Phipatanakul W, Que L, Raissy H, Robison RG, Ross K, Sheehan W, Smith LJ, Solway J, Sorkness CA, Sullivan-Vedder L, Wenzel S, White S, Israel E; NHLBI AsthmaNet. Step-Up Therapy in Black Children and Adults with Poorly Controlled Asthma. N Engl J Med. 2019 Sep 26;381(13):1227-1239. doi: 10.1056/NEJMoa1905560.
PubMed 31553835

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Best African American Response to Asthma Drugs
ClinicalTrials.gov ID: NCT01967173
Acronym / sponsor ID: BARD / AsthmaNet 006
Conditions: Asthma
Keywords: Asthma, Fluticasone, Salmeterol
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 574 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Feb 2014
Primary completion: 1 Jul 2017 (actual)
Study completion: 1 Jul 2017 (actual)
First posted: 22 Oct 2013 (estimated)
Results: Posted 15 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Crossover sequence 1	Experimental	Drug: Flovent Diskus® 100 mcg, Drug: Flovent Diskus® 250 mcg, Drug: Advair Diskus® 100/50 mcg, Drug: Advair Diskus® 250/50 mcgFlovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg
Crossover sequence 2	Experimental	Drug: Flovent Diskus® 100 mcg, Drug: Flovent Diskus® 250 mcg, Drug: Advair Diskus® 100/50 mcg, Drug: Advair Diskus® 250/50 mcgAdvair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg
Crossover sequence 3	Experimental	Drug: Flovent Diskus® 100 mcg, Drug: Flovent Diskus® 250 mcg, Drug: Advair Diskus® 100/50 mcg, Drug: Advair Diskus® 250/50 mcgFlovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg
Crossover sequence 4	Experimental	Drug: Flovent Diskus® 100 mcg, Drug: Flovent Diskus® 250 mcg, Drug: Advair Diskus® 100/50 mcg, Drug: Advair Diskus® 250/50 mcgAdvair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg
Crossover sequence 5	Experimental	Drug: Flovent Diskus® 250 mcg, Drug: Flovent Diskus® 500 mcg, Drug: Advair Diskus® 100/50 mcg, Drug: Advair Diskus® 250/50 mcgFlovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg
Crossover sequence 6	Experimental	Drug: Flovent Diskus® 250 mcg, Drug: Flovent Diskus® 500 mcg, Drug: Advair Diskus® 100/50 mcg, Drug: Advair Diskus® 250/50 mcgAdvair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg
Crossover sequence 7	Experimental	Drug: Flovent Diskus® 250 mcg, Drug: Flovent Diskus® 500 mcg, Drug: Advair Diskus® 100/50 mcg, Drug: Advair Diskus® 250/50 mcgFlovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg
Crossover sequence 8	Experimental	Drug: Flovent Diskus® 250 mcg, Drug: Flovent Diskus® 500 mcg, Drug: Advair Diskus® 100/50 mcg, Drug: Advair Diskus® 250/50 mcgAdvair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg

Who may qualify

Ages: 5 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Individuals who self-report Black ancestry (with at least 1 Black grandparent).
Able to perform reproducible spirometry according to ATS criteria.
Clinical history consistent with asthma.
Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted.
Asthma confirmed either by: (1) Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR (2) PC20FEV1 ≤ 16 mg/ml OR (3) an absolute relative change in %predicted FEV1 of ≥ 12% over two measurements documented by repeat spirogram over the previous year

Key exclusion criteria (11 listed)

Medical contraindication to LABA or history of adverse reactions to ICS or LABA preparations or any of their ingredients.
Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment.
Unwilling to provide a blood sample for DNA extraction and genetic analysis.
Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study or that would place the participant at increased risk.
Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year.

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
Flovent Diskus® 100 mcgFlovent is an ICS	Drug	Crossover sequence 1, Crossover sequence 2, Crossover sequence 3, Crossover sequence 4
Flovent Diskus® 250 mcgFlovent is an ICS	Drug	Crossover sequence 1, Crossover sequence 2, Crossover sequence 3, Crossover sequence 4, Crossover sequence 5, Crossover sequence 6, Crossover sequence 7, Crossover sequence 8
Flovent Diskus® 500 mcgFlovent is an ICS	Drug	Crossover sequence 5, Crossover sequence 6, Crossover sequence 7, Crossover sequence 8
Advair Diskus® 100/50 mcgAdvair is an ICS/LABA combination	Drug	Crossover sequence 1, Crossover sequence 2, Crossover sequence 3, Crossover sequence 4, Crossover sequence 5, Crossover sequence 6, Crossover sequence 7, Crossover sequence 8
Advair Diskus® 250/50 mcgAdvair is an ICS/LABA combination	Drug	Crossover sequence 1, Crossover sequence 2, Crossover sequence 3, Crossover sequence 4, Crossover sequence 5, Crossover sequence 6, Crossover sequence 7, Crossover sequence 8

Primary outcome

The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen.
Time frame: The last 12 weeks of each 14-week treatment period
This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.

Results and safety

Results posted to the registry on 15 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Crossover Sequence 1	69	45
Crossover Sequence 2	69	52
Crossover Sequence 3	71	55
Crossover Sequence 4	71	57
Crossover Sequence 5	73	56
Crossover Sequence 6	72	49
Crossover Sequence 7	75	57
Crossover Sequence 8	74	50

Primary outcome: The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen.

Time frame: The last 12 weeks of each 14-week treatment period. Number. Unit: probability

Measure	Adolescents and Adults n = 294	Children n = 280
Advair 100/50 superior to Flovent 250	.49	.46
Advair 100/50 inferior to Flovent 250	.28	.46
Advair 100/50 superior to Flovent 500	.53	–
Advair 100/50 inferior to Flovent 500	.27	–
Advair 100/50 superior to Advair 250/50	.42	.47
Advair 100/50 inferior to Advair 250/50	.36	.49
Advair 100/50 superior to Flovent 100	–	.53
Advair 100/50 inferior to Flovent 100	–	.41

Adolescents and Adults: p = 0.003, Mixed Models Analysis
Children: p = 0.9, Mixed Models Analysis
Adolescents and Adults: p <0.001, Mixed Models Analysis

Population analysed: Not all treatments were used in all participants. Flovent 500 was not used in children and Flovent 100 was not used in adolescents and adults

Adverse events

Time frame: Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flovent 250 in Pediatric Group	8 of 280 (2.9%)	64 of 280 (22.9%)	0 of 280
Advair 250/50 in Pediatric Group	1 of 280 (0.4%)	52 of 280 (18.6%)	0 of 280
Flovent 100 in Pediatric Group	2 of 280 (0.7%)	43 of 280 (15.4%)	0 of 280
Advair 100/50 in Pediatric Group	4 of 280 (1.4%)	27 of 280 (9.6%)	0 of 280
Flovent 500 in Adolescent/Adult Group	10 of 294 (3.4%)	53 of 294 (18%)	0 of 294
Advair 250/50 in Adolescent/Adult Group	7 of 294 (2.4%)	47 of 294 (16%)	0 of 294
Flovent 250 in Adolescent/Adult Group	7 of 294 (2.4%)	35 of 294 (11.9%)	0 of 294
Advair 100/50 in Adolescent/Adult Group	8 of 294 (2.7%)	34 of 294 (11.6%)	0 of 294

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31553835Wechsler ME, Szefler SJ, Ortega VE, Pongracic JA, Chinchilli V, Lima JJ, Krishnan JA, Kunselman SJ, Mauger D, Bleecker ER, Bacharier LB, Beigelman A, Benson M, Blake KV, Cabana MD, Cardet JC, Castro M, Chmiel JF, Covar R, Denlinger L, DiMango E, Fitzpatrick AM, Gentile D, Grossman N, Holguin F, Jackson DJ, Kumar H, Kraft M, LaForce CF, Lang J, Lazarus SC, Lemanske RF Jr, Long D, Lugogo N, Martinez F, Meyers DA, Moore WC, Moy J, Naureckas E, Olin JT, Peters SP, Phipatanakul W, Que L, Raissy H, Robison RG, Ross K, Sheehan W, Smith LJ, Solway J, Sorkness CA, Sullivan-Vedder L, Wenzel S, White S, Israel E; NHLBI AsthmaNet. Step-Up Therapy in Black Children and Adults with Poorly Controlled Asthma. N Engl J Med. 2019 Sep 26;381(13):1227-1239. doi: 10.1056/NEJMoa1905560.
AsthmaNetLink 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.

William Busse, MD study chair

University of Wisconsin, Madison

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Flovent Diskus® 100 mcg, Flovent Diskus® 250 mcg and Flovent Diskus® 500 mcg in people with Asthma, run by Milton S. Hershey Medical Center at 28 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 9 inclusion and 11 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 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Nov 2018). 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?

The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen. (time frame: The last 12 weeks of each 14-week treatment period). 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 NCT01967173, which also lists 1 linked publication.

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 15 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.