Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

Guangzhou Women and Children's Medical Center

Status and phase: Completed; Phase 4

Conditions: Adenoidal Hypertrophy

Treatments: Drug: Placebo; Drug: Placebo + placebo; Drug: mometasone furoate; Drug: mometasone furoate + Oxymetazoline; Drug: Oxymetazoline + Placebo; Drug: mometasone furoate + Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02559440

81500772

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 6 patient groups, including a placebo group

mometasone furoate

Active Comparator group

Description:

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.

Treatment:

Drug: mometasone furoate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Oxymetazoline + Placebo

Active Comparator group

Description:

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.

Treatment:

Drug: Oxymetazoline + Placebo

Placebo + placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo + placebo

mometasone furoate + Placebo

Active Comparator group

Description:

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.

Treatment:

Drug: mometasone furoate + Placebo

mometasone furoate + Oxymetazoline

Active Comparator group

Description:

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.

Treatment:

Drug: mometasone furoate + Oxymetazoline