Last updated: 11/07/2018 16:43:57
Study In Adults And Adolescents With Seasonal Allergic Rhinitis.
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg in Adult and Adolescent Subjects with Seasonal Allergic Rhinitis in Europe
Trial description: Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as ‘hay fever’, it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).
Timeframe: N/A
Secondary outcomes:
Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.
Timeframe: N/A
Interventions:
Drug: GW685698X
Enrollment:
288
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
W. J. Fokkens, R. Jogi, S. Reinartz, I. Sidorenko, B. Sitkauskiene, C. van Oene, M. A. Faris, A. Ellsworth, M. F. Caldwell. Once daily fluticasone furoate nasal spray is effective in seasonal allergic rhinitis caused by grass pollen . Allergy. September 2007;62, Issue 9:1078 - 1084.
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
May 2005 to August 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Informed consent.
- Must be an outpatient.
- A significant concomitant medical condition.
- Use of corticosteroids or allergy or medications or tobacco.
Inclusion and exclusion criteria
Inclusion criteria:
- Informed consent.
- Must be an outpatient.
- Females must be using appropriate contraception.
- Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
- Must be able to comply with study procedures.
- Must be literate.
Exclusion criteria:
- A significant concomitant medical condition.
- Use of corticosteroids or allergy or medications or tobacco.
- Clinically significant abnormal ECG.
- Laboratory abnormality.
- Positive pregnancy test.
- Allergy to any component of the investigational product.
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
2005-12-08
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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