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

NCT ID: NCT00491153

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Keywords

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asthma airway hyperresponsiveness dry powder mannitol inhalation methacholine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ernst Omenaas, MD, PhD

Role: STUDY_DIRECTOR

Haukeland University Hospital

Locations

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St.Olavs Hospital, University Hospital of Trondheim

Trondheim, South Trøndelag, Norway

Site Status

Dr Alf Magne Heggli medical practice

Trondheim, South Trøndelag, Norway

Site Status

Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

References

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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(1):4. doi: 10.1186/1465-9921-10-4.

Reference Type BACKGROUND
PMID: 19161635 (View on PubMed)

Other Identifiers

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2006-006469-17

Identifier Type: OTHER

Identifier Source: secondary_id

4.2006.3606(REK)

Identifier Type: -

Identifier Source: org_study_id