Study of Asthma and Nasal Steroids

Asthma Clinical Trial

— STAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118312
• Other study ID #: ALAACRC-11
• Secondary ID: R01 HL089464-01A
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2010
• Last updated: October 29, 2015
• Start date: September 2010
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: JHSPH Center for Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Rhinitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
United States	Vermont Lung Center at the University of Vermont	Burlington	Vermont
United States	Univeristy of Virginia	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Davis Heart and Lung Research Institute	Columbus	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	University of Missouri, Kansas City School of Medicine	Kansas City	Missouri
United States	Univeristy of Miami School of Medicine	Miami	Florida
United States	North Shore-Long Island Jewish Health System	New Hyde Park	New York
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	New York University School of Medicine	New York	New York
United States	University of California, San Diego	San Diego	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	University of South Florida College of Medicine	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	New York Medical College	Valhalla	New York

Sponsors (3)

Lead Sponsor	Collaborator
JHSPH Center for Clinical Trials	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test (ACT)	Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control	24 weeks	No
Secondary	Childhood Asthma Control Test	Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control	24 weeks	No

External Links

•   ALA-ACRC Webpage