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NCT00491153 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00491153
Other study ID # 4.2006.3606(REK)
Secondary ID 2006-006469-17
Status Terminated
Phase N/A
First received June 22, 2007
Last updated December 17, 2013
Start date September 2007
Est. completion date December 2012

Study information
Verified date December 2013
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 35
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 50 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Haukeland University Hospital Bergen
Norway Dr Alf Magne Heggli medical practice Trondheim South Trøndelag
Norway St.Olavs Hospital, University Hospital of Trondheim Trondheim South Trøndelag

Sponsors (2)
Lead Sponsor Collaborator
St. Olavs Hospital Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. doi: 10.1186/1465-9921-10-4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial challenge test 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. 1 day No
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