NCT02559440

Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

Combination Therapy With Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy Concomitant With Allergic Rhinitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Guangzhou Women and Children's Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenoidal Hypertrophy

Interventions

Type	Name	Description
DRUG	mometasone furoate	50μg, 1 puff in each nostril every evening
DRUG	Placebo	1 puff in each nostril every evening
DRUG	Oxymetazoline + Placebo	1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening
DRUG	Placebo + placebo	1 puff of placebo +1 puff of Placebo in each nostril every evening
DRUG	mometasone furoate + Placebo	1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening
DRUG	mometasone furoate + Oxymetazoline	1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-02-01
• Completion: 2015-08-01
• First posted: 2015-09-24
• Last updated: 2015-09-24