Last updated: 11/07/2018 16:43:05
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
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official 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
Trial description: The purpose of this study is to assess any effect in children with seasonal and/or perennial allergic rhinitis by GW685698X aqueous nasal spray (versus vehicle placebo nasal spray) on growth using knemometry.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: N/A
Secondary outcomes:
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]).
Timeframe: N/A
Interventions:
Drug: GW685698X
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gradman J, Caldwell M, Wolthers O. Comparison of short term lower leg growth in children treated with fluticasone furoate nasal spray and vehicle placebo spray. Allergy. 2007;62(Suppl 83):226-227.
Gradman J, Caldwell M, Wolthers O. Knemometric assessment of short-term lower-leg growth in children with allergic rhinitis (AR) treated with fluticasone furoate* (FF) nasal spray.*USAN approved name. J Allergy Clin Immunol. 2007;119(1 Suppl):S304.
Gradman, Josefine; Caldwell, Mark F.; Wolthers, Ole D. Lack of Effect on Short-Term Growth with Fluticasone Furoate Nasal Spray as Assessed by Knemometry. Clin Ther. August 2007;29, Issue 8:1738-1747.
Medical condition
Rhinitis, Allergic, Perennial and Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
April 2005 to November 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 years
Accepts healthy volunteers
No
- Females (ages 6 to 11) who have not begun menses.
- Males (ages 6 to 12).
- History of abnormal growth or gross malnutrition.
- Clinically significant laboratory abnormality.
Inclusion and 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-16-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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