Comparison Of Molecular Targets In Mild To Severe Asthmatics And Healthy Subjects

Inclusion Criteria

• •Male or female subjects aged between 18-60 years inclusive at screening.
• •A female subject of childbearing potential must be using effective contraceptive
• •measures described in protocol for at least one month prior to Screening and should continue using the same contraceptive measure during the study until completion of follow-up procedures. Non child-bearing potential is defined as pre-menopausal females with documented (medical report verification) hysterectomy or surgical sterilisation, or post-menopausal women who have been amenorrheic for more than 1 year and having estradiol and FSH levels consistent with menopause.). Other methods include male partner who is sterile prior to female subject's entry into study and is the sole sexual partner for that female subject.
• •Atopic or non-atopic subjects
• •Able to comprehend the nature of this research protocol and other relevant medical information and the ability to give written informed consent prior to participation in the study.
• •Able to comply with the requirements and restrictions listed in the consent form.
• •Available to complete the study and all measurements.
• •Read, comprehend, and write English at a sufficient level to complete study related materials.
• •Have a pre-history of a physician's diagnosis of asthma, with exclusion of other significant pulmonary
• •No significant disease other than asthma.
• •No history of steroid myopathy.
• •No history of recent exposure to live vaccine in the past 4 weeks and no intention to undergo live vaccination during the prednisolone trial or during the month following the trial.
• •Intermittent asthma with FEV1 ≥ 80% predicted.
• •Positive beta agonist reversibility as shown by greater than 12% improvement on FEV1or greater than 200ml improvement in FEV1 within 30 minutes following the administration of Albuterol Inhalation Aerosol OR a positive PC20 to Methacholine Challenge smaller than 16 mcg.
• •Not currently taking inhaled steroids (ICS), and has not taken ICS for at least 6 months prior to screening.
• •A non-smoker (as demonstrated by a negative urine cotinine) for at least the past 12 months with a pack history ≤5 pack years.
• •Have a pre-history of a physician's diagnosis of asthma, with exclusion of other significant pulmonary diseases
• •No significant disease other than asthma.
• •No history of steroid myopathy.
• •No history of recent exposure to live vaccine in the past 4 weeks and no intention to undergo live vaccination during the prednisolone trial or during the month following the trial.
• •Mild to moderate persistent asthmatic with FEV1 ≥ 80% predicted
• •Asthma symptoms ranging from daily to less than once a day
• •Positive beta agonist reversibility as shown by greater than 12% improvement on FEV1or greater than 200ml improvement in FEV1 within 30 minutes following the administration of Albuterol Inhalation Aerosol OR a positive PC20 to Methacholine Challenge smaller than 16 mcg.
• •On regular inhaled steroid treatment (from 200-500 mcg FP daily or equivalent). Short and long acting beta-2 agonists, anti-cholinergies, and Leukotriene receptor antagonists are allowed as concurrent medication.
• •A non-smoker (as demonstrated by a negative urine cotinine) for at least the past 12 months with a pack history ≤5 pack years.
• •Have a pre-history of a physician's diagnosis of asthma, with exclusion of other significant pulmonary diseases
• •No significant disease other than asthma.
• •No history of steroid myopathy.
• •No history of recent exposure to live vaccine in the past 4 weeks and no intention to undergo live vaccination during the prednisolone trial or during the month following the trial.
• •Severe persistent asthmatic
• •Subjects should have at least one (if on oral steroids) or two (if only on inhaled steroids) of the following indices:
• •1. FEV1 \<80% (post bronchodilator) and FEV1/FVC ratio \<70% predicted;
• •2. Daily symptoms ± nocturnal symptoms as recorded in diary cards during run-in;
• •3. severe exacerbations (as defined FACET study Tattersfield 1999) of ≥ twice a year in at least one of the last two years, as recorded in clinical records
• •Positive beta agonist reversibility as shown by greater than 12% improvement on FEV1 or greater than 200ml improvement in FEV1 within 30 minutes following the administration of Albuterol Inhalation Aerosol OR a positive PC20 to Methacholine Challenge smaller than 16 mcg.
• •High dose inhaled steroids (≥ to 1000 mcg FP daily or equivalent), oral steroids of ≤ 20mg prednisolone a day or equivalent.
• •A non-smoker (as demonstrated by a negative urine cotinine) for at least the past 12 months with a pack history ≤5 pack years.
• •Have a pre-history of a physician's diagnosis of asthma, with exclusion of other significant pulmonary
• •No significant disease other than asthma.
• •No history of steroid myopathy.
• •No history of recent exposure to live vaccine in the past 4 weeks and no intention to undergo live vaccination during the prednisolone trial or during the month following the trial.
• •Smokers (as demonstrated by a positive urine cotinine) with a pack history \>5 pack years
• •Mild to moderate persistent asthmatic with FEV1 ≥ 80% predicted
• •Asthma symptoms less than once a day
• •Positive beta agonist reversibility as shown by greater than 12% improvement on FEV1or greater than 200ml improvement in FEV1 within 30 minutes following the administration of Albuterol Inhalation Aerosol OR a positive PC20 to Methacholine Challenge smaller than 16mcg.
• •On regular inhaled steroid treatment (200-500 mcg FP daily or equivalent). (NB:
• •A non-smoker (as demonstrated by a negative urine cotinine) for at least the past 12 months with a pack history ≤5 pack years.