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

Stopped early · Phase 1

Conditions studied: Asthma

In brief

The primary goal of this study is to compare the expression of key GSK drug targets across the 4 asthma phenotypes and healthy subjects and secondarily to evaluate changes in target expression in response to a 2-week course of corticosteroids across the 4 asthma phenotypes. Each asthmatic subject in this study will undergo two bronchoscopies. Each healthy subject will undergo one bronchoscopy.

Key facts

Study ID

NCT00331058

Run by

GlaxoSmithKline

People needed

58

Starts

2006-02-18

Expected to finish

2011-07-07

Last updated by the study team

2017-06-28

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Additional inclusion criteria for the steroid naïve intermittent asthmatics - Cohort A
• 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.
• Additional inclusion criteria for the mild to moderate persistent asthmatics on regular inhaled steroids - Cohort B
• 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.

You may not qualify if…

• As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study.
• The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
• Subject is female who is pregnant or lactating.
• Having participated within 30 days or 5 half-lives in a study receiving an investigational drug.
• Having participated within 30 days in a study with an invasive procedure.
• Donation of a 500 mL of blood within the previous 56 days or intention to donate within 56 days of the end of the last bronchoscopy.
• Evidence of recent infection that would preclude participation in the steroid trial in the judgement of the study physician. The subject may be deferred to later participation. History of abnormal bruising or bleeding.
• History of alcohol or drug abuse within five years.
• Positive urine test for drugs of abuse including alcohol at screen.
• Abnormal (clinically significant) clinical laboratory test results.
• Medical history of cirrhosis, hepatitis C or hepatitis B or HIV
• Doing night-shift work that will change pattern within at least 5 days prior to study start through the first follow up visit for Cohorts A through D. This does not include the follow up visits at 6 and 12 months.
• Female subjects who are unwilling or unable to use an appropriate method of contraception
• Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
• Concomitant medications that may interfere with study procedures or evaluations.
• History of hypersensitivity to any of the following medications: Lidocaine, Fentanyl, Versed, Demerol, Midazolam, Epinephrine, Flumanzenil and Naloxon.
• History of hypersensitivity to bronchodilator (such as Albuterol)
• ALL WOMEN OF CHILD BEARING POTENTIAL WHO DO NOT WISH TO USE PROTOCOL APPROVED METHODS OF CONTRACEPTION WILL BE EXCLUDED.
• Additional exclusion criteria for the steroid naïve intermittent asthmatics - Cohort A
• Subject has changed asthma medication within 1 month prior to screening.
• Subject had an asthma exacerbation in the previous month.
• Known sensitivity or allergy to prednisolone.
• History of tuberculosis, glaucoma, epilepsy, severe affective disorder or peptic ulceration.
• Current use or use within the previous 1 month of oral corticosteroids.
• Current use of any asthma medication except short acting inhaled β2 agonists

Where it is running

• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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