Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: FP; Drug: SFC; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517634

HZA109912

Details and patient eligibility

About

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.

Full description

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

Enrollment: 23 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 6 patient groups

Sequence 1: FP, SFC, Placebo

Experimental group

Description:

Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period

Treatment:

Drug: Placebo

Drug: FP

Drug: SFC

Sequence 2: Placebo, SFC, FP

Experimental group

Description:

Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period

Treatment:

Drug: Placebo

Drug: FP

Drug: SFC

Sequence 3: SFC, FP, Placebo

Experimental group

Description:

Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period

Treatment:

Drug: Placebo

Drug: FP

Drug: SFC

Sequence 4: SFC, Placebo, FP

Experimental group

Description:

Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period

Treatment:

Drug: Placebo

Drug: FP

Drug: SFC

Sequence 5: FP, Placebo, SFC

Experimental group

Description:

Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period

Treatment:

Drug: Placebo

Drug: FP

Drug: SFC

Sequence 6: Placebo, FP, SFC

Experimental group

Description:

Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period

Treatment:

Drug: Placebo

Drug: FP

Drug: SFC