A multi-centre, randomised, double-blind, placebo-controlled, four-way incomplete crossover study to examine efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat administration of three inhaled doses (10, 15, and 20mcg) of GSK159797 - N/A
- Conditions
- Persistent asthmatic subjects
- Registration Number
- EUCTR2005-005329-68-DE
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 60
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
1.Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases (e.g. chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia).
2.Female subjects aged between 18 to 70 years.
Females are eligible to participate only if they are currently non-pregnant and non-lactating. Females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following:
•Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject
•Implants of levonorgestrel
•Injectable progestogen
•Oral contraceptive (either combined estrogen/progestin or progestin only)
•Any intrauterine device (IUD) with a documented failure rate of less than 1% per year, or
•Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
•The contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds/90 kilos)
•Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test is required for all females. This test will be performed at Screening and Day 1 and Day 7 of each treatment period, and follow up.
3.Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of less than or equal to 10 pack years.
Pack years = Number of cigarettes per day/20 x Number of years smoked
4.Subjects with clinically stable persistent asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 between 60 and 90% predicted (having abstained from bronchodilators for the required period). Predicted values are based on the ECCS 1993 normal ranges.
5.During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of greater than or equal to 12.0% over baseline and an absolute change of greater than or equal to 300mL within 30 minutes following a single 400mcg salbutamol dose.
6.Subjects who are able and willing to give written informed consent to take part in the study.
7.Subjects who are currently taking ICS at a total daily dose of 200 to 500mcg of FP or equivalent ICS.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1.Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, may affect the safety of the subject or outcome of this study.
The list of additional excluded conditions/diseases includes, but is not limited to the following:
Congestive heart failure, Immunologic compromise, Known aortic aneurysm, Current malignancy [history of malignancy is acceptable only if subject has been in remission for one year prior to Visit 1 (remission = no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to Visit 1)], Clinically significant coronary heart disease, Tuberculosis (current or quiescent), Clinically significant cardiac arrhythmia, Cushing’s disease, Stroke within 3 months of Visit 1, Addison’s disease, Uncontrolled hypertension (a systolic blood pressure >170, or diastolic blood pressure >100), Uncontrolled diabetes mellitus, Poorly controlled peptic ulcer, Recent history of drug or alcohol abuse, Hematologic, hepatic, or renal disease
2.A screening Holter ECG tracing that reveals clinically concerning arrhythmias (including, but not limited to, ventricular ectopic runs of greater than or equal to 4 beats, R on T phenomena, bigeminy, trigeminy).
3.A mean QTc(B) value at screening >450 msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
4.Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit
5.Subjects with a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with either respiratory arrest or hypoxic seizures.
6.Asthma exacerbations requiring treatment with oral corticosteroids: any exacerbations within 3 months of the screening visit or two or more exacerbations within 6 months of the screening visit or admittance to hospital for an asthma exacerbation within 1 year of the screening visit.
7.Subjects who have taken high doses of inhaled (>500mcg FP/day or equivalent) or oral steroids within 8 weeks of the screening visit.
8.Subjects who have changed their inhaled corticosteroid treatment within the last 4 weeks before screening or can be expected to do so during the study.
9.Subjects who have received a new chemical entity drug, or have received a marketed compound in a clinical study, within 3 months of the screening visit.
10.Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GSK159797 inhalation powder (i.e., lactose or COA).
11.Subjects with a positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody or HIV (if tested according to site SOPs) result within 3 months of the start of the study.
12.Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject’s proper completion of the protocol requirements, including compliance. Abuse of alcohol is defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units.
13.Subjects who have a screening haemoglobin value <110mg/L.
14.Subjects with known hypersensitivity to salbutamol or any ingredient in this preparation
15.History of severe milk protein allergy.
16.Subjects weighing <50kg.
17.Subjects
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method