Clinical Trial: Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Guangzhou Women and Children's Medical Center

Current Primary Outcome: symptom score assessed by TNSS scopring system [ Time Frame: six months ]

Original Primary Outcome: symptom score [ Time Frame: six months ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • adenoid size [ Time Frame: six months ]
  • nasal volume [ Time Frame: six months ]


Information By: Guangzhou Women and Children's Medical Center

Dates:
Date Received: September 21, 2015
Date Started: February 2014
Date Completion:
Last Updated: September 23, 2015
Last Verified: September 2015