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Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Asthma

Treatments

Drug: budesonide/formoterol Turbuhaler

Study type

Interventional

Funder types

Industry

Identifiers

NCT00235911
BN-00S-0011

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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