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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00491153

Enrollment

Registered

2007-06-25

Start date

2007-09-30

Completion date

2012-12-31

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, airway hyperresponsiveness, dry powder mannitol inhalation, methacholine

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial challenge test	1 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.

Countries

Norway

Outcome results