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Study of Asthma and Nasal Steroids (STAN)

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ClinicalTrials.gov Identifier: NCT01118312
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : November 30, 2015
Last Update Posted : November 30, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
JHSPH Center for Clinical Trials

Brief Summary:
The trial will study the effectiveness of nasal steroids for the treatment of chronic rhinitis and/or sinusitis on asthma control.

Condition or disease Intervention/treatment Phase
Asthma Rhinitis Sinusitis Drug: Mometasone Furoate monohydrate Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers
Study Start Date : September 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Sinusitis

Arm Intervention/treatment
Active Comparator: Nasal Steroid
Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Drug: Mometasone Furoate monohydrate
Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months
Other Name: Nasonex

Placebo Comparator: Placebo
Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Other: Placebo
Intranasal placebo spray




Primary Outcome Measures :
  1. Asthma Control Test (ACT) [ Time Frame: 24 weeks ]
    Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control


Secondary Outcome Measures :
  1. Childhood Asthma Control Test [ Time Frame: 24 weeks ]
    Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118312


Locations
Show Show 19 study locations
Sponsors and Collaborators
JHSPH Center for Clinical Trials
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Anne Dixon, MD University of Vermont

Additional Information:
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Responsible Party: JHSPH Center for Clinical Trials
ClinicalTrials.gov Identifier: NCT01118312    
Other Study ID Numbers: ALAACRC-11
R01 HL089464-01A2 ( Other Identifier: NIH/NHLBI )
R01 HL00895101-01A2 ( Other Identifier: NIH/NHLBI )
First Posted: May 6, 2010    Key Record Dates
Results First Posted: November 30, 2015
Last Update Posted: November 30, 2015
Last Verified: October 2015
Keywords provided by JHSPH Center for Clinical Trials:
Asthma
Rhinitis
Sinusitis
Chronic
ACRC
STAN
Nasal steroid
Mometasone
Nasal spray
Additional relevant MeSH terms:
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Asthma
Rhinitis
Sinusitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents