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

This study is currently recruiting participants.

Verified December 2011 by St. Olavs Hospital

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 9, 2011

Last verified: December 2011

History of Changes

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:

MedlinePlus related topics: Asthma

Drug Information available for: Mannitol

U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Estimated Enrollment:	90
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2012
Estimated 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

Contacts

Contact: Malcolm Sue-Chu, MB, PhD	+47 73 86 9401	msuechu@online.no
Contact: Ernst Omenaas		ernst.omenaas@helse-bergen.no

Locations

Norway
St.Olavs Hospital, University Hospital of Trondheim	Recruiting
Trondheim, South Trøndelag, Norway, N-7006
Principal Investigator: Malcolm Sue-Chu, MB, PhD
Dr Alf Magne Heggli medical practice	Recruiting
Trondheim, South Trøndelag, Norway
Principal Investigator: Alf M Heggli, MD
Haukeland University Hospital	Active, not recruiting
Bergen, Norway

Sponsors and Collaborators

St. Olavs Hospital

Haukeland University Hospital

Investigators

Study Director:

Ernst Omenaas, MD, PhD

Haukeland University Hospital

More Information

Publications:

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.

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 9, 2011
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 May 19, 2013

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