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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014