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

This study has been terminated.
(due to low recruitment rate secondary to very stringent inclusion criteria)
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00491153
First received: June 22, 2007
Last updated: December 17, 2013
Last verified: December 2013

June 22, 2007
December 17, 2013
September 2007
December 2012   (final data collection date for primary outcome measure)
sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial challenge test [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT00491153 on ClinicalTrials.gov Archive Site
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Sensitivity and Specificity of Aridol Challenge for a Diagnosis of Asthma by a Specialist Pulmonologist
Sensitivity and Specificity of Aridol Challenge for a Diagnosis of Asthma by a Specialist Pulmonologist

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

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients with a tentative diagnosis of asthma or suspected asthma referred to a pulmonologist for evaluation

Asthma
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Anderson SD, Charlton B, Weiler JM, Nichols S, Spector SL, Pearlman DS; A305 Study Group. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009 Jan 23;10:4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
16 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00491153
4.2006.3606(REK), 2006-006469-17
No
St. Olavs Hospital
St. Olavs Hospital
Haukeland University Hospital
Study Director: Ernst Omenaas, MD, PhD Haukeland University Hospital
St. Olavs Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP