Last updated: 11/07/2018 08:16:09
A study in asthmatics to determine the efficacy and dose response of repeat doses of GW870086X on forced expiratory volume in 1 second (FEV1)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study to determine the efficacy and dose response of repeat inhaled doses of GW870086X on FEV1 in adults with Persistent Asthma
Trial description: This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once daily or 3mg GW870086X once daily.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline (Day 1) in forced expiratory volume in one second (FEV1) at Day 28
Timeframe: Baseline (Day 1) and Day 28
Secondary outcomes:
Change from Baseline (Day 1) in FEV1 on Day 7, Day 14 and Day 21
Timeframe: Baseline (Day 1), and Days 7, 14, and 21
Change from Baseline (Day 1) in PEFR measured twice daily over 28 days
Timeframe: Baseline (Day 1) and up to 28 days
Mean number of Salbutamol Puffs taken over period
Timeframe: From Baseline (Day 1) up to 28 days
Number of participants with adverse events (AEs) and serious adverse events (SAEs) over period
Timeframe: Up to 12 weeks
Number of participants with hematological and potential clinical chemistry (PCC)parameters of clinical concern over period
Timeframe: Up to 12 weeks
Mean systolic and diastolic blood pressure over 28 days
Timeframe: Up to 28 days
Mean heart rate over 28 days
Timeframe: Up to 28 days
Interventions:
Drug: GW870086 Placebo
Drug: GW870086 2mg
Drug: GW870086 3mg
Drug: GW870086 4mg
Device: DISKHALER
Enrollment:
136
Observational study model:
Not applicable
Primary completion date:
2011-19-08
Time perspective:
Not applicable
Clinical publications:
Bareille1, K Hardes, Jonathan Robertson, Angela Davis, Ann Allen. Efficacy of a New Selective Steroid (GW870086) in Asthma: an Adaptive, Randomised, Controlled Trial. Curr Drug Ther. 2013;8(2):69-75
Medical condition
Asthma
Product
GW870086
Collaborators
Not applicable
Study date(s)
December 2010 to August 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Male or female between 18 and 65 years
- A female subject is eligible to participate if she is of: Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
- A positive test for Hepatitis B or Hepatitis C antibody.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female between 18 and 65 years
- A female subject is eligible to participate if she is of: Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
- Male subjects must agree to use one of the protocol contraception methods.
- Body weight, men ≥ 50 kg, women ≥ 45 kg and BMI within the range 18.5 – 29.0 kg/m2 (inclusive).
- 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
- Severity of Disease: A best FEV1 of 60%-85% of the predicted normal value during the Visit 1 screening period.
- No history of smoking within 6 months of the start of the study and with a total pack year history of ≤10 pack years
- Capable of giving written informed consent
- Single QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- AST and ALT < 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Exclusion criteria:
- A positive test for Hepatitis B or Hepatitis C antibody.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- The subject has a positive pre-study drug/alcohol screen unless a positive can be explained by the patients’ medication.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- Clinically significant abnormalities in safety laboratory analysis at screening, as determined by the investigator.
- Subject is hypertensive at screening.
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
- Administration of oral, injectable or dermal steroids within 8 weeks of screening.
- Exacerbation of asthma within 4 weeks prior to the first dose of study medication.
- Respiratory Infection that is not resolved within the 4 weeks before screening and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study.
- Any asthma exacerbation requiring oral corticosteroids within 8 weeks of screening. A subject must not have had any hospitalisation for asthma within 6 months prior to screening
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Paracetamol is an exception and will be permitted at daily doses of up to 4 g from screening to follow-up.
- Has taken Xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates and/or long-acting beta-2 agonists within 1 week prior to screening and is unable to abstain from them throughout the study.
- Unable to abstain from other medications other than short acting inhaled beta-2 agonists and paracetamol (up to 4 g per day) 7 days before screening until the follow-up visit.
- Unable to abstain from medication or supplements that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, from screening and throughout the study.
- Unable to use the DISKHALER® device correctly.
- History of sensitivity to any of the study medications.
- Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- The subject is not able to understand or comply with protocol requirements, instructions and protocol stated restrictions.
- Vulnerable subjects.
- Subject is mentally or legally incapacitated.
- Urinary cotinine levels indicative of smoking or history within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Trial location(s)
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
Newton Park, Port Elizabeth, South Africa, 6045
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-19-08
Actual study completion date
2011-19-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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