A randomised, double-blind, placebo-controlled, 2-way crossover study to determine the efficacy of repeat inhaled doses of GW870086X on FEV1 in mild to moderate asthmatics
- Conditions
- AsthmaMedDRA version: 9.1Level: LLTClassification code 10003555Term: Asthma bronchial
- Registration Number
- EUCTR2008-008254-23-DE
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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%).
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) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br> 28 days on PEFR in mild to moderate asthmatics, compared with placebo. <br><br>• To determine the efficacy of repeat inhaled doses of GW870086X once daily over<br> 28 days on rescue medication usage in mild to moderate asthmatics, compared<br> with placebo.<br><br>• To assess the safety and tolerability of repeat inhaled doses of GW870086X<br> once daily over 28 days in mild to moderate asthmatics, compared with placebo<br><br>• To determine the efficacy of repeat inhaled doses of GW870086X once daily on FEV1 in mild to moderate asthmatics, compared with placebo.<br>;Primary end point(s): Change from baseline in FEV1 on Day 28
- Secondary Outcome Measures
Name Time Method