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

This study is not yet open for participant recruitment.

Verified by St. Olavs Hospital, November 2006

Sponsors and Collaborators:	St. Olavs Hospital Haukeland University Hospital
Information provided by:	St. Olavs Hospital
ClinicalTrials.gov Identifier:	NCT00491153

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

Condition
Asthma

MedlinePlus related topics: Asthma

Drug Information available for: Mannitol Methacholine Methacholine chloride

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Convenience Sample, Prospective Study
Official Title:	Sensitivity and Specificity of Aridol Challenge for a Diagnosis of Asthma by a Specialist Pulmonologist

Further study details as provided by St. Olavs Hospital:

Estimated Enrollment:	90
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2008

Detailed Description:

The comparator is methacholine provocation

Eligibility

Ages Eligible for Study:	16 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts

Contact: Malcolm Sue-Chu, MB, PhD

+47 73 86 9401

malcolm.sue-chu@stolav.no

Locations

Norway, Hordaland
Straume Spesialistsenter
Bergen, Hordaland, Norway
Krambua legesenter
Bergen, Hordaland, Norway
Norway, South Trøndelag
St.Olavs Hospital, University Hospital of Trondheim
Trondheim, South Trøndelag, Norway, N-7006
Dr Alf Magne Heggli medical practice
Trondheim, South Trøndelag, Norway

Sponsors and Collaborators

St. Olavs Hospital

Haukeland University Hospital

Investigators

Study Director:

Ernst Omenaas, MD, PhD

Haukeland University Hospital

More Information

Study ID Numbers:	4.2006.3606(REK), 2006-006469-17(EUDRACT)
Study First Received:	June 22, 2007
Last Updated:	June 22, 2007
ClinicalTrials.gov Identifier:	NCT00491153
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by St. Olavs Hospital:

asthma
airway hyperresponsiveness
dry powder mannitol inhalation
methacholine

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Mannitol
Lung Diseases

Methacholine Chloride
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009