Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy
Adenoidal Hypertrophy
About this trial
This is an interventional treatment trial for Adenoidal Hypertrophy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
mometasone furoate
Placebo
Oxymetazoline + Placebo
Placebo + placebo
mometasone furoate + Placebo
mometasone furoate + Oxymetazoline
In the first treatment stage, 120 children were assigned to mometasone furoate (50μg, 1 puff in each nostril every evening) after two week's run-in period.
In the first treatment stage, 120 children were assigned to control group (normal saline) after two week's run-in period.
Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving Oxymetazoline and placebo.
Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving placebo and placebo.
Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving mometasone furoate and placebo.
Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving mometasone furoate and Oxymetazoline.