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Completed

NCT Number: NCT00716963

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

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)

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate (Flovent Diskus) 250 mcg

Drug

Flovent Diskus 250 mcg

Other names: fluticasone propionate Flovent Diskus250 mcg

budesonide 400 mcg

Drug

budesonide 400 mcg

Other names: Pulmicort Turbuhaler 200 mcg

Placebo

Other

Placebo

Primary outcomes

  1. The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.

    Time frame: Before inhalation 3 hours

  2. The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.

    Time frame: 7 hours after challenge

Secondary outcomes

  1. The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).

    Time frame: Before inhalation both evaluations (0 hours)

  2. The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)

    Time frame: sputum @ 7 hours

  3. The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)

    Time frame: 24 hours methacholine and sputum

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 16, 2008
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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