Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?

Hamilton Health Sciences (HHS)

Status and phase: Completed; Phase 4

Conditions: Mild Intermittent Asthma

Treatments: Other: Placebo; Drug: Fluticasone propionate (Flovent Diskus) 250 mcg; Drug: budesonide 400 mcg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00716963

AZ2008lr

Details and patient eligibility

About

The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded, randomized, crossover study in which single doses of placebo, will be compared to Fluticasone propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from post-allergen peak)

Full description

The aim of this pilot study is to evaluate whether fluticasone propionate affects the late allergic reaction after a single dose post-allergen challenge administered following cessation of the early allergic reaction.

Six subjects with mild asthma will be asked to volunteer for the study.The diagnosis of asthma will be and includes the presence of variable airflow limitation and AHR (PC20 methacholine < 16 mg/mL). Subjects will be asked to participate if they demonstrate an allergen-induced early and late asthmatic response of at least 20% and 15% reduction in FEV1, respectively.

The study will consist of 4 periods, composed of a screening allergen period with 3 subsequent allergen challenge/treatment periods. Each period will be separated with a washout of at least 2 weeks. Subjects who demonstrate a dual asthmatic response in the screening period will be selected for randomization to treatment.

Enrollment: 7 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild asthma
• nonsmokers
• allergen-induced early and late asthmatic response

Exclusion criteria

• no medication other than infrequent ( < twice weekly) inhaled beta2-agonists
• not be exposed to sensitizing allergens
• asthma exacerbation or respiratory tract infection in the past4 weeks

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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7 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Fluticasone propionate (Flovent Diskus) 250 mcg

Treatment:

Drug: Fluticasone propionate (Flovent Diskus) 250 mcg

2

Active Comparator group

Description:

budesonide 400mcg

Treatment:

Drug: budesonide 400 mcg

3

Placebo Comparator group

Description:

placebo

Treatment:

Other: Placebo