Last updated: 11/04/2018 05:35:09
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Multi-centre, randomised, double-blind, placebo-controlled, four-way incomplete block crossover study, to examine efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat administration of three inhaled doses (25, 100 and 400 mcg once daily) of GW642444
Trial description: In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline (pre-dose on Day 1) in the mean of 23 and 24 hour (h) visit (pre-bronchodilator and pre-dose) trough FEV1 after repeat dosing over 14 days
Timeframe: From Baseline (pre-dose on Day 1) and up to 14 days
Secondary outcomes:
Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14
Timeframe: From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14
Mean change from Baseline (pre-dose on Day 1) in morning (AM) Peak expiratory flow rate (PEFR) from electronic flow meter over Days 2-15
Timeframe: Baseline (pre-dose on Day 1) and up to 15 days
Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14
Timeframe: Baseline (pre-dose on Day 1) and up to 14 days
Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15
Timeframe: Baseline (pre-dose on Day 1), Day 2, and Day 15
Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days
Timeframe: Baseline (pre-dose on Day 1) and up to Day 14
Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14
Timeframe: Day 1, 7, and 14
Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14
Timeframe: Day 1, 7, and 14
Interventions:
Drug: GW642444 (25, 100 & 400 mcg/day)
Drug: Salmeterol 50mcg
Enrollment:
55
Observational study model:
Not applicable
Primary completion date:
2007-10-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
May 2006 to January 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Subjects with a documented history of persistent asthma.
- Current non-smokers.
- Subjects with significant past or present disease which which may affect their safety.
- Upper or lower respiratory tract infection within 4 weeks of screening.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with a documented history of persistent asthma.
- Current non-smokers.
- Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
- Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.
Exclusion criteria:
- Subjects with significant past or present disease which which may affect their safety.
- Upper or lower respiratory tract infection within 4 weeks of screening.
- History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
- Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study.
- Patients weighing less than 50kg.
Trial location(s)
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
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
2007-10-01
Actual study completion date
2007-10-01
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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