A multicenter study to investigate the Sensitivity and Specificity of Aridol (Mannitol)Challenge as compared with Methacholine Challenge to predict a diagnosis of Asthma by a Specialist Pulmonologist in subjects referred with a history suggestive of asthma but without a definitive diagnosis.

Phase 1

• Conditions: The detection of bronchial hyperresponsiveness in patients with suspected asthma

• Registration Number: EUCTR2006-006469-17-NO
• Lead Sponsor: St Olavs Hospital, University Hospital of Trondheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-03
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The subject must: have given informed consent to participate in this study, have been referred with a provisional diagnosis of asthma or have possible asthma, have an FEV1> 70% of the predicted value at visit 1, be between 16 and 50 years, be able to perform all of the techniques necessary to measure lung function, be able to understand the requirements of the study and be able to complete all of the forms necessary, be taking effective birth control if female of childbearing potential
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The subject must NOT: use medications six weeks prior to the Screening visit or during the study that would interfere with bronchial provocation challenge testing, currently use cholinesterase-inhibitor medication , have had upper or lower respiratory tract infection within the previous 6 weeks, have known aortic or cerebral aneurysm, cirrhosis or portal hypertension, have had recent major surgery, have had recent cataract surgery, have a history of heart disease that would increase risk risk of performing methacholine or Aridol challenge, have had cardiac ischemia or malignant arrhytmias, have uncontrolled hypertension, have smoked within the past year or have a >10 pack year smoking history, have other chronic restrictive or obstructive pulmonary diseases, have a clinically significantly abnormal chest X-ray, be skin test positive to seasonal and perennial aeroallergens that are present in the environment during the time that the subject is participating in the study, have a medical condition that in the opinion of the Investigator would impair the ability of the subject to participate, have an inability to perform spirometry of acceptable quality, be intolerant to Aridol, methacholine or salbutamol, be pregnant or lactating, have participated in any other investigative drug study within 4 weeks of study entry, have previously received an Aridol challenge

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified