SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-05-31

Brief Summary

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To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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formoterol

Intervention Type DRUG

budesonide/formoterol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A diagnosed history of asthma for at least 6 months
* Mild and stable asthma, only using β2-agonists as needed for the last 4 weeks.
* FEV1 \>70% of predicted normal value (post-bronchodilator value).
* Skin prick test positive to pollen, animal dander or house dust mite.

Exclusion Criteria

* Any significant respiratory disease, other than asthma.
* Upper or lower respiratory tract infection within 4 weeks before inclusion.
* Use of:

1. inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma.
2. inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening.
3. regular NSAIDs

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No