Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting

AstraZeneca100 enrolled

Overview

The primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Asthma

Interventions

budesonide/formoterol TurbuhalerDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of mild to moderate asthma, FEV1 ³ 60% of predicted normal values pre-bronchodilator, daily use of inhaled GCS during the last 3 months Exclusion Criteria: * Regular need of \>4 inhalations of a short-acting b2-agonist/day, known or suspected hypersensitivity to any of the investigational drugs or inhaled lactose, use of any b-blocking agent, having smoked ³10 pack-years

Locations (2)

Research Site

Appingedam, Netherlands

Research Site

Groningen, Netherlands

Outcomes

Primary Outcomes

Change in PD20 histamine

Secondary Outcomes

number of asthma-control days, time to first mild asthma exacerbation, number of mild asthma exacerbation days, asthma symptom scores (day and night), FEV1, PEF (morning and evening), Number of inhalations with iGCS and mean dose of iGCS

Data from ClinicalTrials.gov

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