Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

External Links