NCT02559440

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

September 21, 2015

Last Update Submit

September 23, 2015

Conditions

Adenoidal Hypertrophy

Outcome Measures

Primary Outcomes (1)

  • symptom score assessed by TNSS scopring system

    six months

Secondary Outcomes (2)

  • 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

Study Arms (6)

mometasone furoate

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Oxymetazoline + Placebo

ACTIVE COMPARATOR

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

Placebo + placebo

PLACEBO COMPARATOR

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

mometasone furoate + Placebo

ACTIVE COMPARATOR

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

mometasone furoate + Oxymetazoline

ACTIVE COMPARATOR

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

Interventions

mometasone furoateDRUG

50μg, 1 puff in each nostril every evening

Also known as: NASONEX
mometasone furoate
PlaceboDRUG

1 puff in each nostril every evening

Placebo
Oxymetazoline + PlaceboDRUG

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

Also known as: Oxymetazoline Hydrochloride Spray + Placebo
Oxymetazoline + Placebo
Placebo + placeboDRUG

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

Also known as: Placebo
Placebo + placebo
mometasone furoate + PlaceboDRUG

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

Also known as: NASONEX + Placebo
mometasone furoate + Placebo
mometasone furoate + OxymetazolineDRUG

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

Also known as: NASONEX + Oxymetazoline Hydrochloride Spray
mometasone furoate + Oxymetazoline

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Mometasone FuroateOxymetazoline

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • renzhong Luo

    Guangzhou Women and Children's Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research secretary

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 24, 2015

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

August 1, 2015

Last Updated

September 24, 2015

Record last verified: 2015-09