NCT01118312

Study of Asthma and Nasal Steroids

Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 388 (actual)
• Sponsor: JHSPH Center for Clinical Trials · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Asthma
• Rhinitis
• Sinusitis

Interventions

Type	Name	Description
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	Placebo	Intranasal placebo spray

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-06-01
• Completion: 2015-06-01
• First posted: 2010-05-06
• Last updated: 2015-11-30
• Results posted: 2015-11-30

Locations

19 sites across 1 country: United States