Adenoidal Hypertrophy
Conditions
Brief summary
The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid hypertrophy children with severe allergic rhinitis.
Detailed description
The investigators performed a two stages, parallel, randomized, double-blind, double-dummy, clinical trial in 240 AH children concomitant with perennial allergic rhinitis. In the first treatment stage, the 240 children were assigned to MF (50μg, 1 puff in each nostril every evening) or control group (normal saline) after two week's run-in period. After 6 week's treatment, the children in MF group were evaluated and grouped as responders and non-responders according to subjective symptoms and objective performance. Responders were followed up for six months and reassessed. Non-responders underwent 2-week washout period and were randomly assigned to 4 groups receiving the following treatments: placebo, OXY (0.05%, 1 puff in each nostril every evening) or MF (50μg, 1 puff in each nostril every evening). All participants received 8 weeks' MF or its placebo plus one week's OXY or its placebo for every second week. After that, the patients were followed for six months and the evaluation was done at different time points.
Interventions
DRUGmometasone furoate
50μg, 1 puff in each nostril every evening
DRUGPlacebo
1 puff in each nostril every evening
DRUGOxymetazoline + Placebo
1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening
1 puff of placebo +1 puff of Placebo in each nostril every evening
DRUGmometasone furoate + Placebo
1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening
DRUGmometasone furoate + Oxymetazoline
1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening
Sponsors
Guangzhou Women and Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* adenoid occluding at least 75% of the nasopharynx at nasal endoscopy * age between 5 and 11 years * chronic obstructive nasal symptoms no less than 12 months * moderate-to-severe AR
Exclusion criteria
* tonsillar hypertrophy * upper respiratory infection within the last 2 weeks * sinonasal anatomic anomalies or diseases * craniofacial malformations * genetic diseases (i.e., Down's syndrome) * neurologic or cardiovascular diseases * immunodeficiency * history of epistaxis * asthma * hypersensitivity to MF or OXY * undergoing intranasal, topical, or systemic steroid or antibiotic treatment within the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom score assessed by TNSS scopring system | six months |
Secondary
| Measure | Time frame |
|---|---|
| adenoid size assessed by nasopharyngoscope （calculated the adenoid area in relation to the nasopharyngeal area） | six months |
| nasal volume assessd by Acoustic rhinometry | six months |
Outcome results
None listed