Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

Adenoidal Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559440
• Other study ID #: 81500772
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2015
• Last updated: September 23, 2015
• Start date: February 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Guangzhou Women and Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoidal Hypertrophy
• Hypertrophy

Intervention

Drug:
• mometasone furoate
50µg, 1 puff in each nostril every evening
• Placebo
1 puff in each nostril every evening
• Oxymetazoline + Placebo
1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening
• Placebo + placebo
1 puff of placebo +1 puff of Placebo in each nostril every evening
• mometasone furoate + Placebo
1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening
• mometasone furoate + Oxymetazoline
1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom score assessed by TNSS scopring system		six months
Secondary	adenoid size assessed by nasopharyngoscope (calculated the adenoid area in relation to the nasopharyngeal area)		six months
Secondary	nasal volume assessd by Acoustic rhinometry		six months