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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00491153
Recruitment Status : Terminated (due to low recruitment rate secondary to very stringent inclusion criteria)
First Posted : June 25, 2007
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Asthma

Study Design

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensitivity and Specificity of Aridol Challenge for a Diagnosis of Asthma by a Specialist Pulmonologist
Study Start Date : September 2007
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial challenge test [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a tentative diagnosis of asthma or suspected asthma referred to a pulmonologist for evaluation
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491153


Locations
Norway
St.Olavs Hospital, University Hospital of Trondheim
Trondheim, South Trøndelag, Norway, N-7006
Dr Alf Magne Heggli medical practice
Trondheim, South Trøndelag, Norway
Haukeland University Hospital
Bergen, Norway
Sponsors and Collaborators
St. Olavs Hospital
Haukeland University Hospital
Investigators
Study Director: Ernst Omenaas, MD, PhD Haukeland University Hospital
More Information

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00491153     History of Changes
Other Study ID Numbers: 4.2006.3606(REK)
2006-006469-17 ( Other Identifier: EUDRACT )
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by St. Olavs Hospital:
asthma
airway hyperresponsiveness
dry powder mannitol inhalation
methacholine

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases