Mannitol inhalations as faster procedure for testing of airways hyper-responsiveness

Completed

Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Respiratory
Chronic lower respiratory diseases

Registration Number: ISRCTN72604310

Lead Sponsor: niversity Medical Center Groningen (UMCG) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

Asthmatics:
1. Episodic symptoms of dyspnea, and/or wheezing, and/or cough
2. Allergic or non-allergic
3. Non current smokers (more than 0.5 years)
4. Provocation Concentration that causes a decrease in forced expiratory volume in one second of 20% (PC20) for MethaCholine (MCh) less than 8 mg/ml

Chronic Obstructive Pulmonary Disease (COPD) patients:
1. Age more than 40 years
2. Active or former smokers, with a smoking history of more than ten pack years
3. Continuous symptoms of cough/sputum and/or dyspnea on exertion
4. No history of asthma
5. Forced expiratory volume in one second (FEV1)/Forced Vital Capacity (FVC) less than 70% and FEV1 between 50 and 80% predicted

Controls:
1. No history of asthma or COPD
2. PC20 MCh more than 8 mg/ml
3. FEV1/FVC more than 70% and FEV1 more than 90% predicted

Exclusion Criteria

1. Age less than 18 years
2. Inability to perform acceptable-quality spirometry or to understand directions given by personnel
3. Severe airflow limitation (FEV1 less than 50% of predicted or less than 1.0 L)
4. Heart attack or stroke in last three months
5. Uncontrolled hypertension, systolic Blood Pressure (BP) more than 200 mmHg, or diastolic BP more than 100 mmHg
6. Known aortic aneurysm
7. Pregnancy
8. Nursing mothers
9. Current use of cholinesterase inhibitor medication (for myasthenia gravis)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time involved in measurement of hyper-responsiveness (including technician time for preparation and cleaning).

Secondary Outcome Measures

Name	Time	Method
1. Patient reported adverse events.<br>2. Patient preference.<br>3. Technician preference.<br>4. Borg score during test.<br>5. Exhaled Breath Condensate (EBC).<br>6. Bronchial Hyper-Reactivity questionnaire (BHR)