Clinical trial NCT00347139: Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Tolerability
Pharmacodynamics
Safety
Pharmacokinetics
GW642444
Asthmatic patients
Efficacy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14
timeFrame: Day 1, 7, and 14
measure: Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14
timeFrame: Day 1, 7, and 14
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Grosshansdorf
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: