NCT00288379

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

February 7, 2006

Last Update Submit

January 21, 2011

Conditions

Asthma

Keywords

Asthmaallergen challengeairway responsivenessairway inflammationSymbicort®

Outcome Measures

Primary Outcomes (1)

  • PD20 methacholine (measured as the change using the measurement before and after each treatment period).

Secondary Outcomes (6)

  • eNO (ppb).

  • Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:

  • Total and differential blood cell count

  • Different Biomarkers

  • Safety endpoints will be incidence of Serious Adverse Events (SAEs)

  • +1 more secondary outcomes

Interventions

formoterolDRUG
budesonide/formoterolDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Any significant respiratory disease, other than asthma.
  • Use of:
  • inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening.
  • regular NSAIDs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Stockholm, Sweden

Location

MeSH Terms

Conditions

Asthma

Interventions

Formoterol FumarateBudesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • AstraZeneca Symbicort Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 8, 2006

Study Start

October 1, 2004

Study Completion

May 1, 2006

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

SE(1)