Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

September 23, 2015 updated by: Wenlong Liu, Guangzhou Women and Children's Medical Center

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

The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid hypertrophy children with severe allergic rhinitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: mometasone furoate
50μg, 1 puff in each nostril every evening
Other Names:
  • NASONEX
Placebo Comparator: Placebo
In the first treatment stage, 120 children were assigned to control group (normal saline) after two week's run-in period.
Drug: Placebo
1 puff in each nostril every evening
Active Comparator: 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.
Drug: Oxymetazoline + Placebo
1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening
Other Names:
  • Oxymetazoline Hydrochloride Spray + Placebo
Placebo Comparator: 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.
Drug: Placebo + placebo
1 puff of placebo +1 puff of Placebo in each nostril every evening
Other Names:
  • Placebo
Active Comparator: 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.
Drug: mometasone furoate + Placebo
1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening
Other Names:
  • NASONEX + Placebo
Active Comparator: 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.
Drug: mometasone furoate + Oxymetazoline
1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening
Other Names:
  • NASONEX + Oxymetazoline Hydrochloride Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
symptom score assessed by TNSS scopring system
Time Frame: six months
six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Investigators

  • Study Chair: renzhong Luo, Guangzhou Women and Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81500772

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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