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| Sponsors and Collaborators: |
Karolinska Institutet University of Athens University Hospital of Crete Universitaria di Ferrara University Ghent Pulmonary Research Institute Grosshansdorf Leiden University Medical Center Imperial College London Université Montpellier National Research Council, Italy University of Southampton Jagiellonian University |
|---|---|
| Information provided by: | Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00555607 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma COPD |
Drug: prednisolone |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | Longitudinal Assessment of Clinical Course and BIOmarkers in Severe Chronic AIRway Disease |
| Enrollment: | 233 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | December 2009 |
| Arms | Assigned Interventions |
|---|---|
|
steroid: Active Comparator
Group receiving oral prednisolone (0.5 mg/kg bodyweight per day) during 14 days.
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Drug: prednisolone
Prednisolone oral tablets (10 mg active ingredient per tablet) once a day at a dose of 0.5mg/kg bodyweight, during 14 days.
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placebo: Placebo Comparator
Group receiving placebo tablets during 14 days, followed by an open prednisolone treatment (0.5 mg/kg bodyweight per day) during a following 14 days.
|
Drug: prednisolone
Prednisolone oral tablets (10 mg active ingredient per tablet) once a day at a dose of 0.5mg/kg bodyweight, during 14 days.
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The BIOAIR project focuses on the sub-group of asthma patients that suffer from severe or difficult-to-control asthma, and who have frequent asthma exacerbations ('attacks'). This sub-group of asthma patients consists of around 10% of all asthma patients, but accounts for more than half of the total community costs for asthma. It is as yet unknown why these patients are so much more severely ill compared to the majority of asthma patients that have controlled disease. No adequate treatment has yet been established. The BIOAIR study was initiated in order to find out more about the mechanisms underlying severe asthma. Since some of the changes that occur in severe asthma are similar to patients with chronic obstructive lung disease (COPD), a group of COPD patients was included and will be studied as well. A group with controlled mild-to-moderate asthma was included for comparative reasons.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For all patients:
For patients with asthma (groups 1 and 2)
1. 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. 2. 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:
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). 3. 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)
Specific for patients with severe asthma (group 2)
Specific for patients with COPD (group 3)
Exclusion Criteria:
General exclusions 1. The patient is pregnant. 2. The patient has a recent history of incapacitating psychotic disorders. 3. The patient is a current or recent past abuser of alcohol or illicit drugs. 4. 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. 5. 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. 6. The patient is mentally or legally incapacitated preventing informed consent from being obtained.
Exclusions because of pulmonary disorders
1. 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.
2. 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). 3. 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.
Exclusions because of medications
1. The patient has received immunosuppressants other than corticosteriods (i.e., methotrexate, gold, troleandomycin, cyclosporin or any other experimental anti-inflammatory drug) within three months of study entry. 2. The patient is currently undergoing immunotherapy. 3. The patient receives chronic oxygen therapy.
Specific exclusion criterion for patients with asthma (groups 1 & 2) 1. The patient has smoked more than five (5) pack years.
Specific exclusion criterion for patients with mild asthma (group 1)
1. The patient requires treatment with long-acting beta-agonists.
Specific exclusion criteria for patients with severe asthma (group 2)
1. The patient is not treated with high doses of inhaled steroids (see above). 2. The patient has not had an exacerbation of asthma during the last year. 3. The patient does not require treatment with long-acting beta-agonists or theophylline as documented during one year.
Specific exclusion criterion for patients with COPD (group 3) 1. The patient has a history of asthma confirmed by a specialist in pulmonary medicine.
Specific exclusion criteria for bronchoscopy (all groups)
Do not start or proceed bronchoscopy if:
Specific exclusion criteria for induced sputum (all groups)
Contacts and Locations| Sweden | |
| Karolinska Institutet | |
| Stockholm, Sweden, 17177 | |
| Principal Investigator: | Sven-Erik Dahlén, Professor | Karolinska Institutet |
More Information
| Study ID Numbers: | BIOAIR, QLG1-CT-2000-01185, GA2LEN, FOOD-CT-2004-506378 |
| Study First Received: | November 7, 2007 |
| Last Updated: | February 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00555607 History of Changes |
| Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
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asthma COPD severe controlled |
mild biomarker exacerbation |
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Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Bronchial Diseases Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Asthma Methylprednisolone acetate Prednisolone acetate Neuroprotective Agents Hormones |
Glucocorticoids Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Prednisolone Hypersensitivity, Immediate Peripheral Nervous System Agents Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Methylprednisolone Hemisuccinate |
|
Anti-Inflammatory Agents Bronchial Diseases Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Methylprednisolone Hemisuccinate |
Immune System Diseases Antineoplastic Agents, Hormonal Gastrointestinal Agents Methylprednisolone acetate Asthma Protective Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Prednisolone Hypersensitivity, Immediate Peripheral Nervous System Agents Central Nervous System Agents Respiratory Hypersensitivity |