Longitudinal Assessment of Adults With Severe Asthma

Completed

• Conditions: Asthma

• Registration Number: NCT01976767
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

Cross-sectional study to characterize cohorts of subjects with asthma and healthy controls in terms of clinical features, physiological measurements and non-invasive measurement of biomarkers and develop phenotype handprints for adults with severe asthma

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Study Completion: 2014-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 725

Inclusion Criteria

1. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to undertaking any study procedures.
2. Male or female subject aged 18 years or older at screening.
3. Able to complete the study and all measurements.
4. Able to read, comprehend, and write at a sufficient level to complete study related materials.
5. Subjects will be allowed to enrol in other studies while taking part on this study. However, Permission from the Scientific Board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.

General

Exclusion Criteria

1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study either because of the risk to the subject due to the study or the influence this may have on the study results.
2. The subject has a history of recreational drug use or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
3. Subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. If a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses.
4. The subject has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. Any U-BIOPRED assessments should be deferred until 3 months after the first dose or invasive procedure. Permission from the Scientific Board must be obtained to enroll or allow the continued participation of a subject enrolled in another study.
5. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
6. The subject has a recent history of incapacitating psychiatric disorders
7. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments (assessments should be deferred).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in asthma medication	3 years	in particular ICS dose, over the duration of the study
Measurement of inflammatory cell counts in blood, sputum and bronchoalveolar lavage (BAL)	3 years
Histopathology of bronchial biopsies in a sub group of subjects	3 years	immunohistochemistry for inflammatory cells and matrix remodelling
Transcriptomics, proteomics and metabolomics will be used on samples such as blood, urine and endobronchial biopsies	3 years	to develop clinically useful phenotype handprints
Sleep and daytime drowsiness as assessed by the Epworth sleepiness scale at baseline and changes over the course of the study	3 years
Anxiety and depression as assessed by the hospital anxiety and depression scale (HADS)	3 years
Daily symptoms and short acting beta agonist (SABA) usage	3 years	measured during the telemonitoring study
Asthma control questionnaire (ACQ) at baseline and changes over the course of the study	3 years
Upper airway symptoms as assessed by the sino-nasal outcomes test (SNOT) at baseline and changes over the course of the study	3 years
Measurement of pulmonary function including spirometry, plethysmography, bronchodilator reversibility and respiratory impedance by forced oscillation technique	3 years
Radiological parameters such as computerized tomography (CT) scan, including assessment of lung structure	3 years
Quality of life as assessed by the asthma quality of life questionnaire (AQLQ)	3 years
Asthma exacerbations	3 years	Number, duration and severity of exacerbations over the time of the study
Lung function decline over the course of the study	3 years