The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid hypertrophy children with severe allergic rhinitis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
50μg, 1 puff in each nostril every evening
1 puff in each nostril every evening
1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening
symptom score assessed by TNSS scopring system
Time frame: six months
adenoid size assessed by nasopharyngoscope (calculated the adenoid area in relation to the nasopharyngeal area)
Time frame: six months
nasal volume assessd by Acoustic rhinometry
Time frame: six months
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1 puff of placebo +1 puff of Placebo in each nostril every evening
1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening
1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening