Asthma, Rhinitis, Sinusitis
Conditions
Keywords
Asthma, Rhinitis, Sinusitis, Chronic, ACRC, STAN, Nasal steroid, Mometasone, Nasal spray
Brief 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.
Interventions
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
OTHERPlacebo
Intranasal placebo spray
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
JHSPH Center for Clinical Trials
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test (ACT) | 24 weeks | Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Childhood Asthma Control Test | 24 weeks | Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nasal Steroid Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months | 189 |
| Placebo Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray | 199 |
| Total | 388 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 33 | 32 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Nasal Steroid | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 72 Participants | 79 Participants | 151 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 117 Participants | 120 Participants | 237 Participants |
| Sex: Female, Male Female | 105 Participants | 106 Participants | 211 Participants |
| Sex: Female, Male Male | 84 Participants | 93 Participants | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 105 / 179 | 127 / 187 |
| serious Total, serious adverse events | 2 / 189 | 9 / 199 |
Outcome results
Primary
Asthma Control Test (ACT)
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
Time frame: 24 weeks
Population: Analysis of adult (18 and above) Asthma Control Scores
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal Steroid | Asthma Control Test (ACT) | 2.95 units on a scale | Standard Error 0.31 |
| Placebo | Asthma Control Test (ACT) | 2.44 units on a scale | Standard Error 0.38 |
Secondary
Childhood Asthma Control Test
Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control
Time frame: 24 weeks
Population: Analysis of Children (less than 18 years old) Childhood Asthma Control Test scores
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal Steroid | Childhood Asthma Control Test | 4.15 units on a scale | Standard Error 0.64 |
| Placebo | Childhood Asthma Control Test | 4.53 units on a scale | Standard Error 0.65 |