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Completed

NCT Number: NCT01098071

Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)

To document the short term & long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the posterior choanae).

Completed

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Key information

Conditions

Adenoids

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.

Exclusion criteria

  • adenoids hypertrophy < 50% of posterior choanae

recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.

Treatment and study plan

Mometasone Furoate Nasal spray

Drug

One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months

Other names: SCH 32088, Nasonex

Primary outcomes

  1. Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score

    Time frame: Baseline and Week 12

    Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).

  2. Degree of Posterior Choana Obstruction at Baseline and Week 12

    Time frame: Baseline and Week 12

    The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.

  3. Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. Severity of Rhinorrhea at Baseline and Week 12

    Time frame: Baseline and Week 12

    Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

  2. Severity of Nasal Congestion at Baseline and Week 12

    Time frame: Baseline and Week 12

    Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

  3. Severity of Nasal Itching at Baseline and Week 12

    Time frame: Baseline and Week 12

    Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

  4. Severity of Sneezing at Baseline and Week 12

    Time frame: Baseline and Week 12

    Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

  5. Severity of Eye Symptoms at Baseline and Week 12

    Time frame: Baseline and Week 12

    Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children

Acronym: NAHCh

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 2, 2010
Registry last updated
May 28, 2024

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.