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

St. Olavs Hospital35 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Asthma

Eligibility

Sex: ALLMin age: 16 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial challenge test

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.

Time frame: 1 day

Data from ClinicalTrials.gov

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