Safety Study To Assess Growth In Children With Seasonal Allergic And/Or Perennial Allergic Rhinitis Treated With GW685698X Aqueous Nasal Spray Or Placebo Nasal Spray

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2016
• Main ID: NCT00109486
• Date of registration: 28/04/2005
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Safety Study To Assess Growth In Children With Seasonal Allergic And/Or Perennial Allergic Rhinitis Treated With GW685698X Aqueous Nasal Spray Or Placebo Nasal Spray
• Scientific title: A Randomised, Double-Blind, Placebo-Controlled, Two-Week Crossover, Knemometric Assessment of the Effect of Fluticasone Furoate Nasal Spray 100mcg Once Daily on Short-Term Growth in Children Aged 6 to 11 Years With Seasonal and/or Perennial Allergic Rhinitis
• Date of first enrolment: April 2005
• Target sample size: 56
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00109486
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Denmark

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

- Females (ages 6 to 11) who have not begun menses.

- Males (ages 6 to 12).

- Tanner Stage 1.

- History of SAR (Seasonal Allergic Rhinitis) or PAR (Perennial Allergic Rhinitis) of
at least one year with either a current level of allergic rhinitis symptoms that
warrants treatment and/or expected symptoms during a majority of the study period.

- Positive skin test to an appropriate seasonal or perennial allergen.

Exclusion criteria:

- History of abnormal growth or gross malnutrition.

- Clinically significant laboratory abnormality.

- History of any condition that may have substantially affected growth.

- Historical or current evidence of clinically significant, uncontrolled disease of any
body system.

- Any asthma other than mild, intermittent asthma controlled by short-acting,
beta-agonists.

- Recent major surgery and/or trauma to the legs.

- History of adrenal insufficiency.

- Current or prior treatment with any medication that may have a potential for an
ongoing effect on linear growth.

- Use of corticosteroids, by any route, within 4 weeks prior to Visit 1.

- Any nasal condition or deformity that would impair nasal breathing or deposition of
medication.

- Physical impairment that would affect the subject's ability to participate in the
study.



Age minimum: 6 Years
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rhinitis, Allergic, Perennial and Seasonal

Intervention(s)

Drug: GW685698X

Primary Outcome(s)

The primary safety endpoint will be the mean growth velocity (mm/wk) in lower leg growth, as determined by knemometry, over a 2-week treatment period with intranasal GW685698X aqueous nasal spray versus a 2-week treatment with placebo nasal spray.

Secondary Outcome(s)

Secondary endpoints will include the frequency and type of clinical adverse events (AEs) experienced during treatment, nasal examinations, vital signs (systolic and diastolic blood pressure, heart rate [pulse]).

Secondary ID(s)

FFR101747

Source(s) of Monetary Support

Please refer to primary and secondary sponsors