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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00347139




Registration number
NCT00347139
Ethics application status
Date submitted
29/06/2006
Date registered
4/07/2006

Titles & IDs
Public title
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
Scientific 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
Secondary ID [1] 0 0
B2C106093
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GW642444 (25, 100 & 400 mcg/day)
Treatment: Drugs - Salmeterol 50mcg

Experimental: GW642444 -

Active comparator: Salmeterol -


Treatment: Drugs: GW642444 (25, 100 & 400 mcg/day)
25, 100 and 400mcg/dose

Treatment: Drugs: Salmeterol 50mcg
Salmeterol 50mcg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From Baseline (pre-dose on Day 1) and up to 14 days
Secondary outcome [1] 0 0
Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14
Timepoint [1] 0 0
From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline (pre-dose on Day 1) and up to 15 days
Secondary outcome [3] 0 0
Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14
Timepoint [3] 0 0
Baseline (pre-dose on Day 1) and up to 14 days
Secondary outcome [4] 0 0
Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15
Timepoint [4] 0 0
Baseline (pre-dose on Day 1), Day 2, and Day 15
Secondary outcome [5] 0 0
Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days
Timepoint [5] 0 0
Baseline (pre-dose on Day 1) and up to Day 14
Secondary outcome [6] 0 0
Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14
Timepoint [6] 0 0
Day 1, 7, and 14
Secondary outcome [7] 0 0
Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14
Timepoint [7] 0 0
Day 1, 7, and 14

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2007
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Hessen
Country [2] 0 0
Germany
State/province [2] 0 0
Schleswig-Holstein
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington
Country [4] 0 0
Russian Federation
State/province [4] 0 0
Moscow
Country [5] 0 0
Sweden
State/province [5] 0 0
Göteborg
Country [6] 0 0
Sweden
State/province [6] 0 0
Stockholm
Country [7] 0 0
United Kingdom
State/province [7] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00347139