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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01098071
First received: April 1, 2010
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Adenoids
Drug: mometasone furoate nasal spray
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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]).

  • Degree of Posterior Choana Obstruction at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of Rhinorrhea at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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]).

  • Severity of Nasal Congestion at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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]).

  • Severity of Nasal Itching at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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]).

  • Severity of Sneezing at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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]).

  • Severity of Eye Symptoms at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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]).


Enrollment: 34
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mometasone furoate nasal spray Drug: mometasone furoate nasal spray
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Other Names:
  • SCH 32088
  • Nasonex

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01098071     History of Changes
Other Study ID Numbers: P04367 - Lebanon
Study First Received: April 1, 2010
Results First Received: June 13, 2011
Last Updated: April 28, 2014
Health Authority: Lebanon: Institutional Review Board

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 26, 2014