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Sensitivity and Specificity of Aridol Challenge for a Diagnosis of Asthma by a Specialist Pulmonologist

Terminated
Conditions
Asthma
Registration Number
NCT00491153
Lead Sponsor
St. Olavs Hospital
Brief Summary

The purpose of this study is to estimate the sensitivity, specificity and positive and negative predictive values of a positive Aridol challenge with respect to a specialist pulmonologist diagnosis of asthma in corticosteroid naive subjects with asthma-like symptoms and no previous diagnosis of asthma. The comparator is methacholine provocation

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
35
Inclusion Criteria
  • Informed consent
  • Provisional or possible asthma diagnosis
  • FEV1 at least 70% of predicted at inclusion
Exclusion Criteria
  • Contraindications for bronchial provocation challenge or spirometry
  • Respiratory tract infection within previous 6 weeks
  • Significant co-morbidity
  • > 10 pack year smoking history
  • Other lung diseases
  • Pregnancy, lactation

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial challenge test1 day

with respect to asthma diagnosis by a specialist pulmonary physician in corticosteroid-naïve subjects presenting with signs and symptoms suggestive of asthma but without a definitive diagnosis.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

St.Olavs Hospital, University Hospital of Trondheim

🇳🇴

Trondheim, South Trøndelag, Norway

Dr Alf Magne Heggli medical practice

🇳🇴

Trondheim, South Trøndelag, Norway

Haukeland University Hospital

🇳🇴

Bergen, Norway

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