Study of Asthma and Nasal Steroids (STAN)
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| ClinicalTrials.gov Identifier: NCT01118312 |
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Recruitment Status :
Completed
First Posted : May 6, 2010
Results First Posted : November 30, 2015
Last Update Posted : November 30, 2015
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Sponsor:
JHSPH Center for Clinical Trials
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
JHSPH Center for Clinical Trials
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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 |
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 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
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Nasal Steroid
Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
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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 |
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Placebo Comparator: Placebo
Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
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Other: Placebo
Intranasal placebo spray |
Primary Outcome Measures :
- 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 :
- 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
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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 19 study locations
Sponsors and Collaborators
JHSPH Center for Clinical Trials
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Anne Dixon, MD | University of Vermont |
Additional Information:
| 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:
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Asthma Rhinitis Sinusitis Chronic ACRC |
STAN Nasal steroid Mometasone Nasal spray |
Additional relevant MeSH terms:
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Rhinitis Sinusitis Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Respiratory Tract Infections Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Mometasone Furoate Anti-Inflammatory Agents Dermatologic Agents Anti-Allergic Agents |