Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adenoidal Hypertrophy

Intervention / Treatment
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* Drug: mometasone furoate
* Drug: Placebo
* Drug: Oxymetazoline + Placebo
* Drug: Placebo + placebo
* Drug: mometasone furoate + Placebo
* Drug: mometasone furoate + Oxymetazoline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adenoid occluding at least 75% of the nasopharynx at nasal endoscopy age between 5 and 11 years chronic obstructive nasal symptoms no less than 12 months moderate-to-severe AR Exclusion Criteria: tonsillar hypertrophy upper respiratory infection within the last 2 weeks sinonasal anatomic anomalies or diseases craniofacial malformations genetic diseases (i.e., Down's syndrome) neurologic or cardiovascular diseases immunodeficiency history of epistaxis asthma hypersensitivity to MF or OXY undergoing intranasal, topical, or systemic steroid or antibiotic treatment within the past 4 weeks

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mometasone furoate<br>In the first treatment stage, 120 children were assigned to mometasone furoate (50μg, 1 puff in each nostril every evening) after two week's run-in period. | Drug: mometasone furoate<br>* 50μg, 1 puff in each nostril every evening<br>* Other names: NASONEX;|
| Placebo Comparator: Placebo<br>In the first treatment stage, 120 children were assigned to control group (normal saline) after two week's run-in period. | Drug: Placebo<br>* 1 puff in each nostril every evening<br>|
| Active Comparator: Oxymetazoline + Placebo<br>Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving Oxymetazoline and placebo. | Drug: Oxymetazoline + Placebo<br>* 1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening<br>* Other names: Oxymetazoline Hydrochloride Spray + Placebo;|
| Placebo Comparator: Placebo + placebo<br>Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving placebo and placebo. | Drug: Placebo + placebo<br>* 1 puff of placebo +1 puff of Placebo in each nostril every evening<br>* Other names: Placebo;|
| Active Comparator: mometasone furoate + Placebo<br>Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving mometasone furoate and placebo. | Drug: mometasone furoate + Placebo<br>* 1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening<br>* Other names: NASONEX + Placebo;|
| Active Comparator: mometasone furoate + Oxymetazoline<br>Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving mometasone furoate and Oxymetazoline. | Drug: mometasone furoate + Oxymetazoline<br>* 1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening<br>* Other names: NASONEX + Oxymetazoline Hydrochloride Spray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom score assessed by TNSS scopring system |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoid size assessed by nasopharyngoscope （calculated the adenoid area in relation to the nasopharyngeal area） |  | six months | 
| nasal volume assessd by Acoustic rhinometry |  | six months |