The development of a questionnaire to assess symptoms of small airways disease in patients with asthma

Completed

Conditions: asthma
inflammation of the airways
10006436

Registration Number: NL-OMON35854

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

• A doctor diagnosis of asthma
• Age: >= 18 and <= 75 years
• A FEF50% value in either the lowest or the highest 25th percentile. (Percentiles based on the total asthma patient group present from Asthma/COPD service)

Exclusion Criteria

• Recent exacerbation asthma (<2 months) or upper respiration tract infection (<2 weeks)
• Severe airway obstruction at baseline, FEV1pred< 50% or < 1.2L
• Diagnosis of COPD or another pulmonary disease
• Pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator).
• Restriction, defined as FVC < 80%pred with FEV1/FVC >0.7

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary purpose of this study is to develop a questionnaire for patients<br /><br>with asthma with and without small airways disease for general and specialist<br /><br>practice. The main study parameter is the FEF50%.Based on the FEF50% patients<br /><br>will be allocated to one of the two groups. The main endpoint of the study is<br /><br>interviews with patients with and without small airways disease. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>FEV1, IVC, FVC, FEF25%, FEF50%, FEF75% with spirometry;<br /><br>TLC, FRC, RV with body box,<br /><br>R5, R20, R5-20 (at 5 and 20Hz), X5 with IOS,<br /><br>FeNO with NO measurements,<br /><br>PC20 methacholine and Δ FEV1 and Δ values with IOS.<br /><br>The result of the Asthma Control Questionnaire (ACQ), Clinical COPD<br /><br>Questionnaire (CCQ) and the Bronchial Hyperresponsiveness Questionnaire (BHQ), </p><br>