Study of Asthma and Nasal Steroids (STAN)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier:
NCT01118312
First received: April 28, 2010
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Asthma
Rhinitis
Sinusitis
Drug: Mometasone Furoate monohydrate
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Study of Asthma and Nasal Steroids

Resource links provided by NLM:


Further study details as provided by American Lung Association Asthma Clinical Research Centers:

Primary Outcome Measures:
  • Asthma Control Score (ACT) and Childhood Asthma Control Score (C- ACT) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Episodes of Poor Asthma Control (EPAC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Methacholine challenge testing [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Measures bronchial hyper-reactivity

  • Sinusitis and rhinitis symptom scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Measured using the Sinus Symptom Score questionnaire.

  • Sinusitis and rhinitis quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The Sinonasal Outcome Test (SNOT-22) and the Sinus and Nasal Quality of Life Survey (SN-5) questionnaires

  • Daily diary cards [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Diary cards provide accounts of: nocturnal asthma awakenings, asthma treatments, nasal and sinus symptoms, health care use (we will also record medications for sinus disease on these cards) and if a patient thinks they are currently in their allergy season.

  • The Asthma Symptom Utility Index (ASUI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Asthma specific quality of life measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Marks Asthma Quality of Life Questionnaire (Marks AQLQ)for participants 15 and older.

    The Children's Health Survey for Asthma (CHSA) for participants 6-15 years.


  • Pulmonary function as measured by FEV1 and forced vital capacity (FVC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Generic health-related quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    The Medical Outcomes Study SF-36 (MOS-36)will be administered to participants 18 and older.

    Child Health Questionnaire (CHQ-PF50)will be administered to participants 6 - 17 years.


  • Interval History / Health Care usage [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rhinitis/Sinusitis Exacerbations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    • Use of additional medication for upper airway symptoms
    • Health Care visit for upper airway symptoms
    • Patient self-report of episode of acute sinusitis or upper respiratory tract infection

  • Serum and nasal lavage specimens [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Collected to evaluate eotaxins and eosinophilic cationic protein (ecp).

  • Exhaled nitric oxide (eNO) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • asthma symptoms and menstruation (Asthma in Females Questionnaire) [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
  • Smoke exposure (Smoke Exposure in Children questionnaire) [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
  • Asthma severity and triggers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Allergy skin testing [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]

Enrollment: 388
Study Start Date: September 2010
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Previous trials completed by the 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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician diagnosed asthma
  • At least 12% increase in 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 > 38.3C 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118312

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
University of California, San Diego
San Diego, California, United States, 92103
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Univeristy of Miami School of Medicine
Miami, Florida, United States, 33136
University of South Florida College of Medicine
Tampa, Florida, United States, 33613
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Missouri
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
North Shore-Long Island Jewish Health System
New Hyde Park, New York, United States, 11040
New York University School of Medicine
New York, New York, United States, 10016
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Davis Heart and Lung Research Institute
Columbus, Ohio, United States, 43210
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Vermont
Vermont Lung Center at the University of Vermont
Burlington, Vermont, United States, 05405
United States, Virginia
Univeristy of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
American Lung Association Asthma Clinical Research Centers
Investigators
Principal Investigator: Anne Dixon, MD University of Vermont
  More Information

Additional Information:
No publications provided

Responsible Party: American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier: NCT01118312     History of Changes
Other Study ID Numbers: ALAACRC-11, R01 HL089464-01A2, R01 HL00895101-01A2
Study First Received: April 28, 2010
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by American Lung Association Asthma Clinical Research Centers:
Asthma
Rhinitis
Sinusitis
Chronic
ACRC
STAN
Nasal steroid
Mometasone
Nasal spray

Additional relevant MeSH terms:
Rhinitis
Asthma
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Paranasal Sinus Diseases
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 16, 2014