AsthmaPhase 4STANNCT01118312
Study of Asthma and Nasal Steroids
A Phase 4 study testing Mometasone Furoate monohydrate in people with Asthma and Rhinitis, run by JHSPH Center for Clinical Trials at 19 sites in United States.
Trial summary
The trial will study the effectiveness of nasal steroids for the treatment of chronic rhinitis and/or sinusitis on asthma control. Read more about this study
- Who is it for?
- Ages 6 years and older
- What is being tested?
- Mometasone Furoate monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 19 sitesUnited States
- Study dates
- Sep 2010to Jun 2015
- 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
- At least 12% increase in forced expiratory volume at one second (FEV1) after 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 16 mg/ml methacholine); either of these can be available from the last 2 years before enrollment
- Poorly controlled asthma as documented by a score of 19 or less on the Asthma Control Test (ACT) for participants 12 and older, and a Childhood Asthma Control Test (C-ACT) for 6-11 years(both V1 and V2).
- Chronic symptoms of rhinitis and sinusitis as measured by a mean score of 1 on the Sino-nasal questionnaire
- Males and females, age 6 and older
Who cannot join
- Co-morbidity that predisposes to complicated rhino-sinusitis (e.g., cystic fibrosis, insulin dependent diabetes mellitus, immunodeficiency disorder)
- Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney or nervous system.
- History of sinus surgery in last 6 months
- Systemic/nasal steroids within last 4 weeks
- Anti-leukotriene medication
- History of upper airway symptoms for less than 8 weeks at the time of enrollment
Show all 20Show fewer
- Fever > 38.3 degrees Celsius or patient history of fever in last 10 days
- Greater than 10 pack year smoking history or active smoking within the last 6 months
- FEV1 < 50% predicted
- Females of childbearing potential that are pregnant or lactating, or unwilling to practice an adequate birth control method
- Allergy or intolerance to nasal mometasone
- Cataracts, history of glaucoma, or other conditions resulting in increased intraocular pressure
- Any investigational drug in the last 6 weeks
- Inability to comply with study procedures, including:
- Inability or unwillingness to provide informed consent (or assent in the case of a minor)
- Inability to take study medication
- Inability to perform baseline measurements
- Completion of less than 10 of the 14 days of screening period diary entry
- Inability to be contacted by phone
- Intention to move out of the area within 6 months
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Vermont Lung Center at the University of Vermont
Burlington, Vermont, 05405
Univeristy of Virginia
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60612
Davis Heart and Lung Research Institute
Columbus, Ohio, 43210
National Jewish Health
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Nemours Children's Clinic
Jacksonville, Florida, 32207
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, 64108
Univeristy of Miami School of Medicine
Miami, Florida, 33136
North Shore-Long Island Jewish Health System
New Hyde Park, New York, 11040
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
New York University School of Medicine
New York, New York, 10016
University of California, San Diego
San Diego, California, 92103
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida College of Medicine
Tampa, Florida, 33613
University of Arizona
Tucson, Arizona, 85724
New York Medical College
Valhalla, New York, 10595
About this study
Official title: Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers
The trial will study the effectiveness of nasal steroids for the treatment of chronic rhinitis and/or sinusitis on asthma control.
Read the detailed description
Previous trials completed by the American Lung Association-Airways Clinical Research Centers (ALA-ACRC) network have identified rhinitis and/or sinusitis as a significant co-morbidity in people with asthma that affects asthma symptoms and control. The objective of this clinical trial is to determine if treatment of chronic rhinitis and/or sinusitis with nasal steroids improves control of asthma in children and adults. Although chronic rhinitis and/or sinusitis have been associated with poor asthma control and increased health care utilization, the effect of treating these diseases on asthma control is not known. This will be a six-month randomized, double-blinded, placebo-controlled trial enrolling 380 participants, 190 children and 190 adults, with poorly controlled asthma and chronic rhinitis/sinusitis. Participants will be randomized to receive nasal steroid or a matching placebo in addition to their regular asthma treatments. The primary objective of the trial will be to evaluate whether the addition of treatment with nasal steroids improves asthma control. We will perform allergy skin testing on all participants and keep a record of pollen counts at all centers, to determine if allergy is an important factor in the response to nasal steroid in participants.
- Being tested
- Mometasone Furoate monohydrate, Placebo
- Keywords
- Asthma, Rhinitis, Sinusitis, Chronic, ACRC, STAN, Nasal steroid, Mometasone, Nasal spray
- Medical subject headings
- Asthma, Rhinitis, Sinusitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate monohydrateDrug
Also called Nasonex
Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months
PlaceboOther
Intranasal placebo spray
| Study group | Role | What they receive |
|---|---|---|
| Nasal Steroid | Active comparator | Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day Receives: Drug: Mometasone Furoate monohydrate |
| Placebo | Placebo comparator | Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test (ACT)
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
Measured: 24 weeks
Secondary outcomes (1)
Childhood Asthma Control Test
Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2014
- Study completionJun 2015
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.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- JHSPH Center for Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Anne Dixon, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118312
- Sponsor's protocol ID
- ALAACRC-11
- Other IDs
- R01 HL089464-01A2, R01 HL00895101-01A2
- Acronym
- STAN
- Status last verified
- Oct 2015
- First submitted
- 28 Apr 2010
- Last updated
- 30 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers
- ClinicalTrials.gov ID
- NCT01118312
- Acronym / sponsor ID
- STAN / ALAACRC-11
- Keywords
- Asthma, Rhinitis, Sinusitis, Chronic, ACRC, STAN, Nasal steroid, Mometasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- JHSPH Center for Clinical TrialsUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Posted 30 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will study the effectiveness of nasal steroids for the treatment of chronic rhinitis and/or sinusitis on asthma control.
Detailed description
Previous trials completed by the American Lung Association-Airways Clinical Research Centers (ALA-ACRC) network have identified rhinitis and/or sinusitis as a significant co-morbidity in people with asthma that affects asthma symptoms and control. The objective of this clinical trial is to determine if treatment of chronic rhinitis and/or sinusitis with nasal steroids improves control of asthma in children and adults. Although chronic rhinitis and/or sinusitis have been associated with poor asthma control and increased health care utilization, the effect of treating these diseases on asthma control is not known. This will be a six-month randomized, double-blinded, placebo-controlled trial enrolling 380 participants, 190 children and 190 adults, with poorly controlled asthma and chronic rhinitis/sinusitis. Participants will be randomized to receive nasal steroid or a matching placebo in addition to their regular asthma treatments. The primary objective of the trial will be to evaluate whether the addition of treatment with nasal steroids improves asthma control. We will perform allergy skin testing on all participants and keep a record of pollen counts at all centers, to determine if allergy is an important factor in the response to nasal steroid in participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Steroid | Active comparator | Drug: Mometasone Furoate monohydrateIntranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day |
| Placebo | Placebo comparator | Other: PlaceboIntranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Physician diagnosed asthma
- At least 12% increase in forced expiratory volume at one second (FEV1) after 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 16 mg/ml methacholine); either of these can be available from the last 2 years before enrollment
- Poorly controlled asthma as documented by a score of 19 or less on the Asthma Control Test (ACT) for participants 12 and older, and a Childhood Asthma Control Test (C-ACT) for 6-11 years(both V1 and V2).
- Chronic symptoms of rhinitis and sinusitis as measured by a mean score of 1 on the Sino-nasal questionnaire
- Males and females, age 6 and older
Key exclusion criteria (20 listed)
- Co-morbidity that predisposes to complicated rhino-sinusitis (e.g., cystic fibrosis, insulin dependent diabetes mellitus, immunodeficiency disorder)
- Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney or nervous system.
- History of sinus surgery in last 6 months
- Systemic/nasal steroids within last 4 weeks
- Anti-leukotriene medication
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 |
|---|---|---|
| Mometasone Furoate monohydrateAlso: NasonexIntranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months | Drug | Nasal Steroid |
| PlaceboIntranasal placebo spray | Other | Placebo |
Primary outcome
Asthma Control Test (ACT)
Time frame: 24 weeks
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
1 secondary outcome
Childhood Asthma Control Test
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ALA-ACRC WebpageLink provided by the sponsor.
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Asthma
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.
Anne Dixon, MD principal investigator
University of Vermont
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 Mometasone Furoate monohydrate in people with Asthma and Rhinitis, 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 5 inclusion and 20 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 30 Nov 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. Some participants in this study may receive a placebo. 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 30 Nov 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?
Asthma Control Test (ACT) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2015.