E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003555 |
E.1.2 | Term | Asthma bronchial |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
• 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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <10 pack years 8. Single QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block. 10. AST and ALT < 2xULN; alkaline phosphatase and bilirubin < 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
|
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in FEV1 on Day 28 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |