Mometasone furoate
Drug50μg, 1 puff in each nostril every evening
Other names: NASONEX
NCT Number: NCT02559440
The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid hypertrophy children with severe allergic rhinitis.
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Notify Me5 year–11 year
All sexes
Interventional
Phase 4
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50μg, 1 puff in each nostril every evening
Other names: NASONEX
1 puff in each nostril every evening
1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening
Other names: Oxymetazoline Hydrochloride Spray + Placebo
1 puff of placebo +1 puff of Placebo in each nostril every evening
Other names: Placebo
1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening
Other names: NASONEX + Placebo
1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening
Other names: NASONEX + Oxymetazoline Hydrochloride Spray
Time frame: six months
Time frame: six months
Time frame: six months
Guangzhou Women and Children's Medical Center
Other
Combination Therapy With Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy Concomitant With Allergic Rhinitis
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