Mannitol inhalations as a faster procedure for testing of airways hyperresponsiveness - Mannitol en AHR

Conditions: Detection of airway hyperresponsiveness in patients with asthma or COPD
MedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2006-003795-35-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

Asthmatics:
-Episodic symptoms of dyspnea, and/or wheezing, and/or cough
-Allergic or non-allergic
-PC20 MCh < 8 mg/ml

COPD patients:
-Age > 40 yrs
-Active or former smokers, with a smoking history of more than 10 packyears
-Continuous symptoms of cough/sputum and/or dyspnea on exertion
-No history of asthma
-FEV1/FVC < 70 % and FEV1 < 80 %pred.

Subjects without hyperresponsiveness:
-No history of asthma or COPD
-PC20 methacholine > 8 mg/mL.
-FEV1/FVC > 70 % and FEV1 > 80 %pred
Are the trial subjects under 18? no
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Age <18 years
-Inability to perform acceptable-quality spirometry or to understand directions given by personnel
-Severe airflow limitation (FEV1 < 50% of predicted or < 1.0 L)
-Heart attack or stroke in last 3 months
-Uncontrolled hypertension, systolic BP > 200, or diastolic BP > 100
-Known aortic aneurysm
-Pregnancy
-Nursing mothers
-Current use of cholinesterase inhibitor medication (for myasthenia gravis)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.To test feasibility of mannitol inhalations in a Dutch pulmonary out-patient clinic.<br>2.To compare time and costs involved in measuring airways hyperresponsiveness by methacholine to mannitol;Secondary Objective: ;Primary end point(s): -Time involved in measurement of hyperresponsiveness (including technician time for preparation and cleaning)<br><br>

Secondary Outcome Measures