Study of Asthma and Nasal Steroids (STAN)
This study is ongoing, but not recruiting participants.
Sponsor:
American Lung Association Asthma Clinical Research Centers
Collaborators:
Information provided by (Responsible Party):
American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier:
NCT01118312
First received: April 28, 2010
Last updated: August 21, 2012
Last verified: August 2012
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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 ]
| Estimated Enrollment: | 380 |
| Study Start Date: | September 2010 |
| Estimated Primary Completion Date: | May 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
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: | August 21, 2012 |
| 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:
|
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-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013