Last updated: 11/04/2018 08:18:45
Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval
Trial description: The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Weighted Mean Change from baseline over 0-6 hours in blood eosinophils post-Allergen challenge on Day 35
Timeframe: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35
Secondary outcomes:
Weighted mean change from baseline over 0-6 hours in blood eosinophils post-Allergen challenge on Day 14
Timeframe: 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14
Weighted mean change from baseline over 0-6 hours in serum IL-5 post-Allergen challenge on Day 35
Timeframe: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35
Weighted mean change from baseline over 0-6 hours in serum IL-5 Post-Allergen Challenge on Day 14
Timeframe: 0-6 hours post allergen challenge, 1 hour after dosing, Day 14
Interventions:
Drug: FP
Drug: SFC
Drug: Placebo
Enrollment:
23
Observational study model:
Not applicable
Primary completion date:
2008-23-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
August 2007 to July 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
- Informed consent.
- Outpatient.
- History of life-threatening asthma.
- Use of proscribed asthma medications.
Inclusion and exclusion criteria
Inclusion criteria:
- Informed consent.
- Outpatient.
- Male or non-pregnant/non-lactating female.
- Aged 18-55.
- Diagnosis of asthma.
- Pre-bronchodilatory FEV1 > 75% predicted.
- Using inhaled short-acting beta-2-agonists (SABA) with no inhaled corticosteroids.
- Judged capable of withholding SABA for at least 6 hours prior to visits.
- Reversibility of >12% and 200mL or PC20 of <8mg/mL.
- Demonstration of atopy
Exclusion criteria:
- History of life-threatening asthma.
- Use of proscribed asthma medications.
- Use of anti-histamines or potent inhibitors of CYP3A4.
- Respiratory tract infection.
- Asthma exacerbation with 4 weeks of Visit 1.
- Subjects with exercise induced asthma only.
- Concurrent respiratory disease.
- Other clinically significant, uncontrolled condition or disease.
- Use of any investigational drug within 30 days.
- Allergic to beta-2-agonists, inhaled corticosteroids or excipients.
- Positive pregnancy test.
- Using immunosuppressive medications.
- Milk protein allergy.
- Factors likely to interfere with attendance.
- Current smokers or ex-smokers with a history of >10 pack years.
- Affiliation wih Investigator site.
- Medications that may affect the course of asthma or interact with sympathomimetic amines.
Trial location(s)
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-23-07
Actual study completion date
2008-23-07
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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