Longitudinal Assessment of Clinical Course and BIOmarkers in Severe Chronic AIRway Disease
BIOAIR
3 other identifiers
interventional
233
1 country
1
Brief Summary
The aim of the project is to study pathogenetic mechanisms in severe asthma and compare those mechanisms in chronic obstructive pulmonary disease (COPD) in order to test the hypothesis that severe asthma and COPD develop into similar chronic degenerative changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Mar 2002
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 7, 2007
CompletedFirst Posted
Study publicly available on registry
November 8, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMarch 3, 2021
March 1, 2021
3.1 years
November 7, 2007
March 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of exacerbations
one year
Secondary Outcomes (3)
Steroid responsiveness
2 weeks
Lung function (Peak Expiratory Flow)
one year
Biomarkers
one year
Study Arms (2)
steroid
ACTIVE COMPARATORGroup receiving oral prednisolone (0.5 mg/kg bodyweight per day) during 14 days.
placebo
PLACEBO COMPARATORGroup receiving placebo tablets during 14 days, followed by an open prednisolone treatment (0.5 mg/kg bodyweight per day) during a following 14 days.
Interventions
Prednisolone oral tablets (10 mg active ingredient per tablet) once a day at a dose of 0.5mg/kg bodyweight, during 14 days.
Eligibility Criteria
You may qualify if:
- For all patients:
- The patient understands the study procedures and agrees to participate by signing the consent form.
- The patient is male or female, at least 18 years of age but no more than 80 years of age at the entry into the study (screening visit).
- For patients with asthma (groups 1 and 2)
- The patient has a history of intermittent or persistent symptoms of wheezing, breathlessness, chest tightness and cough. The diagnosis of asthma must have been confirmed by a specialist in pulmonary medicine.
- The patient fulfils one or several of the following criteria for reversible airway obstruction, as documented during the last 5 years before the study or at screening visit:
- An increase in FEV1 more than 9% of predicted (or improvement by 200 mL) after administration of 4 puffs of 100 microg salbutamol dose-aerosol inhaler via a spacer, or after additional inhalation of four puffs of 20 microg ipratropium bromide (Atrovent) administered through a large volume spacer.
- A mean diurnal variation in Peak Expiratory Flow (PEF) of more than 15% on more than 4 days/week for at least 2 weeks, as calculated by the following equation:
- (highest PEF-lowest PEF)/mean PEF
- An increase in FEV1 of at least 400 mL after a course of prednisolone 0.5mg/kg/day for 14 days.
- In patients with a FEV1 more than 70% predicted, demonstrated bronchial hyperresponsiveness to histamine, methacholine, isocapnic hyperventilation, exercise or other indirect challenges (according to established local methods).
- The patient is a non-smoker or has a total smoking history of less than 5 pack years. In the case the patient is smoking, it must be less than 10 cigarettes a day and the asthma must have started before smoking.
- Specific for patients with mild to moderate asthma (group 1)
- The patient has stable disease with minimal symptoms, no exacerbations or hospitalisations during the last year.
- The patient uses inhaled steroids regularly, but not more than 800 microg/day budesonide or beclomethasone, or up to 500 microg/day fluticasone.
- +16 more criteria
You may not qualify if:
- The patient is pregnant.
- The patient has a recent history of incapacitating psychotic disorders.
- The patient is a current or recent past abuser of alcohol or illicit drugs.
- The patient has a history of malignancy, is known to be positive for HIV, or other states that are considered to interfere with study conduct or scientific interpretations.
- The patient cannot read or comprehend written material, or is in the opinion of the investigator, for other reasons unlikely to understand and follow the study procedures.
- The patient is mentally or legally incapacitated preventing informed consent from being obtained.
- The patient is unable to perform acceptable spirometry, peak flow measurements and/or complete diary cards in a satisfactory way during the period between visit 1 and visit 3B (optimisation period and prednisolone/placebo trial). If the patient is unable to use the electronic Peak Flow meters/Diary cards, it is acceptable to use an ordinary mechanical meter (e.g. Mini-Wright) together with a paper version of the diary card. Patients that are unable to use the mechanical meter and paper diary card during the period between visit 1 and 3B cannot enter the follow-up year.
- The patient has, in addition to asthma or COPD, any other pulmonary disorder that according to the investigator would interfere with the study procedures or scientific evaluation (e.g. tuberculosis).
- The patient suffers from chronic hypercapnic respiratory failure as indicated by an elevated pCO2 (\>47 mm Hg or 6,25 kPa). In case of doubt this should be confirmed with pulse oximetry or blood gas sampling.
- The patient has received immunosuppressants other than corticosteroids (i.e., methotrexate, gold, troleandomycin, cyclosporin or any other experimental anti-inflammatory drug) within three months of study entry.
- The patient is currently undergoing immunotherapy.
- The patient receives chronic oxygen therapy.
- \. The patient has smoked more than five (5) pack years.
- The patient is not treated with high doses of inhaled steroids (see above).
- The patient has not had an exacerbation of asthma during the last year.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- University of Athenscollaborator
- University Hospital of Cretecollaborator
- Università degli Studi di Ferraracollaborator
- University Ghentcollaborator
- Pulmonary Research Institute Grosshansdorfcollaborator
- Leiden University Medical Centercollaborator
- Imperial College Londoncollaborator
- Université Montpelliercollaborator
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italycollaborator
- University of Southamptoncollaborator
- Jagiellonian Universitycollaborator
Study Sites (1)
Karolinska Institutet
Stockholm, 17177, Sweden
Related Publications (1)
Kupczyk M, Haque S, Middelveld RJ, Dahlen B, Dahlen SE; BIOAIR Investigators. Phenotypic predictors of response to oral glucocorticosteroids in severe asthma. Respir Med. 2013 Oct;107(10):1521-30. doi: 10.1016/j.rmed.2013.07.014. Epub 2013 Aug 27.
PMID: 23993706DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sven-Erik Dahlén, Professor
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 7, 2007
First Posted
November 8, 2007
Study Start
March 1, 2002
Primary Completion
April 1, 2005
Study Completion (Estimated)
December 1, 2026
Last Updated
March 3, 2021
Record last verified: 2021-03