Study of Asthma and Nasal Steroids (STAN)

JHSPH Center for Clinical Trials

Status and phase

Completed

Phase 4

Conditions

Asthma

Rhinitis

Sinusitis

Treatments

Drug: Mometasone Furoate monohydrate

Other: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01118312

ALAACRC-11

R01 HL00895101-01A2 (Other Identifier)

R01 HL089464-01A2 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

388 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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