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Completed

NCT Number: NCT02559440

Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

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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Key information

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mometasone furoate

Drug

50μg, 1 puff in each nostril every evening

Other names: NASONEX

Placebo

Drug

1 puff in each nostril every evening

Oxymetazoline + Placebo

Drug

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

Other names: Oxymetazoline Hydrochloride Spray + Placebo

Placebo + Placebo

Drug

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

Other names: Placebo

mometasone furoate + Placebo

Drug

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

Other names: NASONEX + Placebo

mometasone furoate + Oxymetazoline

Drug

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

Other names: NASONEX + Oxymetazoline Hydrochloride Spray

Primary outcomes

  1. symptom score assessed by TNSS scopring system

    Time frame: six months

Secondary outcomes

  1. adenoid size assessed by nasopharyngoscope (calculated the adenoid area in relation to the nasopharyngeal area)

    Time frame: six months

  2. nasal volume assessd by Acoustic rhinometry

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 24, 2015
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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