Adenoidal Hypertrophy Clinical Trial
Official title:
Combination Therapy With Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy Concomitant With Allergic Rhinitis
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.
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