The aim of this study is to develop a patient reported outcome tool specific to small airways disease, which assesses symptoms and signs of small airways disease and could help in addition to FEF50% to discriminate between asthmatic patients with…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary purpose of this study is to develop a questionnaire for patients
with asthma with and without small airways disease for general and specialist
practice. The main study parameter is the FEF50%.Based on the FEF50% patients
will be allocated to one of the two groups. The main endpoint of the study is
interviews with patients with and without small airways disease.
Secondary outcome
FEV1, IVC, FVC, FEF25%, FEF50%, FEF75% with spirometry;
TLC, FRC, RV with body box,
R5, R20, R5-20 (at 5 and 20Hz), X5 with IOS,
FeNO with NO measurements,
PC20 methacholine and Δ FEV1 and Δ values with IOS.
The result of the Asthma Control Questionnaire (ACQ), Clinical COPD
Questionnaire (CCQ) and the Bronchial Hyperresponsiveness Questionnaire (BHQ),
Background summary
Asthma is a chronic inflammatory disorder of the large, intermediate and small
airways. Inflammation of the small airways contributes to the severity of the
disease and affects the quality of life of patients with asthma. However, the
exact role and relevance of small airways disease in asthma is still unclear.
This is partly due to the difficulty of measuring small airways pathology with
a sensitive and specific parameter. The most commonly used variable as an
indicator of small airway obstruction is the FEF50%. Currently, it is not known
which clinical symptoms are associated with small airways disease and how
patients will perceive small airway abnormalities. This knowledge is important
to assess small airways disease in patients with asthma and adjust therapy to
improve quality of life.
Study objective
The aim of this study is to develop a patient reported outcome tool specific to
small airways disease, which assesses symptoms and signs of small airways
disease and could help in addition to FEF50% to discriminate between asthmatic
patients with and without small airways disease.
Study design
This is an observational study, with lung function measurements and an
interview.
Intervention
Bronchial provocationtest with methacholine
Study burden and risks
Asthma patients will spend a total of two visits in the hospital. The first
visit will take maximum 5 hours and the second visit a maximum of 2 hours.
The risk associated with participation contains temporally dyspnea after the
methacholine provocation test.
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01360294 |
| CCMO | NL36847.042.11 |