Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
Completed · Phase 4 · Has a placebo group
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT00517634
- Run by
- GlaxoSmithKline
- People needed
- 23
- Starts
- 2007-08-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2016-12-16
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- GSK Investigational Site — Madison, Wisconsin, United States
- GSK Investigational Site — Manchester, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.