Mild Intermittent Asthma
Conditions
Keywords
late allergic response, fluticasone propionate
Brief summary
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)
Detailed 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.
Interventions
DRUGFluticasone propionate (Flovent Diskus) 250 mcg
Flovent Diskus 250 mcg
DRUGbudesonide 400 mcg
budesonide 400 mcg
OTHERPlacebo
Placebo
Sponsors
AstraZeneca
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1. | Before inhalation 3 hours |
| The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1. | 7 hours after challenge |
Secondary
| Measure | Time frame |
|---|---|
| The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils) | sputum @ 7 hours |
| The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils). | Before inhalation both evaluations (0 hours) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Screening/Baseline Participants | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Screening/Baseline Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 |
Outcome results
Primary
The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.
Time frame: Before inhalation 3 hours
Population: Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate (Flovent Diskus) 250 mcg | The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1. | -30.5 percentage fall FEV1 | Standard Deviation 9.3 |
| Budesonide 400mcg | The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1. | -39.0 percentage fall FEV1 | Standard Deviation 12.3 |
| Placebo | The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1. | -31.9 percentage fall FEV1 | Standard Deviation 10.6 |
Primary
The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.
Time frame: 7 hours after challenge
Population: Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate (Flovent Diskus) 250 mcg | The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1. | -11.6 percentage fall FEV1 | Standard Deviation 14.2 |
| Budesonide 400mcg | The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1. | -14.7 percentage fall FEV1 | Standard Deviation 6.6 |
| Placebo | The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1. | -24 percentage fall FEV1 | Standard Deviation 7.2 |
Secondary
The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)
Time frame: sputum @ 7 hours
Secondary
The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)
Time frame: 24 hours methacholine and sputum
Secondary
The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).
Time frame: Before inhalation both evaluations (0 hours)