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
Study complete
Study complete
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:
Enrollment:
56
Primary completion date:
Not applicable
Observational study model:
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
- Inclusion criteria:
- Females (ages 6 to 11) who have not begun menses.
Inclusion and exclusion criteria
Inclusion 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
Study complete
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.
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