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
  Purpose

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
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensitivity and Specificity of Aridol Challenge for a Diagnosis of Asthma by a Specialist Pulmonologist

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 35
Study Start Date: September 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 22, 2007
Last Updated: December 17, 2013
Health Authority: Norway: Norwegian Social Science Data Services

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

ClinicalTrials.gov processed this record on April 22, 2014