Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-08-31

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.

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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.

Conditions

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Adenoidal Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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mometasone furoate

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.

Group Type ACTIVE_COMPARATOR

mometasone furoate

Intervention Type DRUG

50μg, 1 puff in each nostril every evening

Placebo

In the first treatment stage, 120 children were assigned to control group (normal saline) after two week's run-in period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 puff in each nostril every evening

Oxymetazoline + Placebo

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.

Group Type ACTIVE_COMPARATOR

Oxymetazoline + Placebo

Intervention Type DRUG

1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening

Placebo + placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo + placebo

Intervention Type DRUG

1 puff of placebo +1 puff of Placebo in each nostril every evening

mometasone furoate + Placebo

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.

Group Type ACTIVE_COMPARATOR

mometasone furoate + Placebo

Intervention Type DRUG

1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening

mometasone furoate + Oxymetazoline

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.

Group Type ACTIVE_COMPARATOR

mometasone furoate + Oxymetazoline

Intervention Type DRUG

1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening

Interventions

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mometasone furoate

50μg, 1 puff in each nostril every evening

Intervention Type DRUG

Placebo

1 puff in each nostril every evening

Intervention Type DRUG

Oxymetazoline + Placebo

1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening

Intervention Type DRUG

Placebo + placebo

1 puff of placebo +1 puff of Placebo in each nostril every evening

Intervention Type DRUG

mometasone furoate + Placebo

1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening

Intervention Type DRUG

mometasone furoate + Oxymetazoline

1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening

Intervention Type DRUG

Other Intervention Names

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NASONEX Oxymetazoline Hydrochloride Spray + Placebo Placebo NASONEX + Placebo NASONEX + Oxymetazoline Hydrochloride Spray

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No