Asthma MedDRA version: 9.1 Level: LLT Classification code 10003555 Term: Asthma bronchial
Conditions
Interventions
Product Name: GW870086X Rotadisk
Product Code: GW870086X
Pharmaceutical Form: Inhalation powder, pre-dispensed
Current Sponsor code: GW870086X
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 65 years of age inclusive. 2. A female subject is eligible to participate if she is of non-childbearing potential. 3. Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose. 4. Body weight, men > 50 kg, women > 45 kg and BMI within the range 19.0 – 29.0 kg/m2 (inclusive). 5. Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short- acting beta-2 agonist therapy by inhalation. 6. A best FEV1 of 40%-85% of the predicted normal value during the Visit 1 screening period. 7. No history of smoking within 6 months of the start of the study, and with a total pack year history of 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening 2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities. 3. A positive pre-study drug/alcohol screen. 4. Subject is mentally or legally incapacitated. 5. Past or present disease, which as judged by the investigator, may affect the outcome of this study. 6. Clinically significant abnormalities in safety laboratory analysis at screening. 7. Subject has known history of hypertension or is hypertensive at screening. 8. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. 9. History of life-threatening asthma. 10. Administration of oral, injectable or dermal steroids within 8 weeks of screening. 11. Administration of intranasal and/or inhaled steroids within 2 week of the screening visit. Prior to this the subject’s maximum daily dose must be less than FP equivalent 250mcg. 12. The subject has a positive pre-study drug/alcohol screen. 13. A positive test for HIV antibody. 14. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. 15. Subjects who are kept due to regulatory or juridical order in an institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of repeat inhaled doses of GW870086X once daily for 28 days on FEV1 in mild to moderate asthmatics, compared with placebo;Secondary Objective: • To determine the efficacy of repeat inhaled doses of GW870086X once daily over 28 days on PEFR in mild to moderate asthmatics, compared with placebo. • To determine the efficacy of repeat inhaled doses of GW870086X once daily over 28 days on rescue medication usage in mild to moderate asthmatics, compared with placebo. • To assess the safety and tolerability of repeat inhaled doses of GW870086X once daily over 28 days in mild to moderate asthmatics, compared with placebo • To determine the efficacy of repeat inhaled doses of GW870086X once daily on FEV1 in mild to moderate asthmatics, compared with placebo. ;Primary end point(s): Change from baseline in FEV1 on Day 28 | — |
Countries
Germany
Outcome results
None listed