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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00372112




Registration number
NCT00372112
Ethics application status
Date submitted
4/09/2006
Date registered
6/09/2006

Titles & IDs
Public title
A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A 2-wk Study to Evaluate the Safety, Tolerability,Pharmacodynamics and Pharmacokinetics of GW642444H(100 Administered Once Daily in the Morning Via DISKUS™ Dry-powder Inhaler)Compared With SEREVENT(Salmeterol)(50mcg Administered Twice Daily Via DISKUS Dry-powder Inhaler)and Placebo in Subject w/COPD
Secondary ID [1] 0 0
B2C108562
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
Other interventions - Placebo

Active comparator: 100 mcg GW642444H - Twice daily in the morning.

Active comparator: 400 mcg GW642444H - Twice daily in the morning.

Active comparator: 50 mcg salmeterol - Twice daily.

Placebo comparator: placebo - Twice daily


Treatment: Drugs: GW642444
GW642444H

Other interventions: Placebo
Placebo administered twice daily
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Timepoint [1] 0 0
Up to Follow-up (17 days)
Secondary outcome [1] 0 0
Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14
Timepoint [1] 0 0
Baseline (Day 1, pre-dose) up to Day 14
Secondary outcome [2] 0 0
Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15
Timepoint [2] 0 0
Baseline (Day 1, pre-dose) up to Day 15
Secondary outcome [3] 0 0
Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14
Timepoint [3] 0 0
Baseline (Day 1, pre-dose) up to Day 15
Secondary outcome [4] 0 0
Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15
Timepoint [4] 0 0
Baseline (Day 1, pre-dose) up to Day 15
Secondary outcome [5] 0 0
Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM
Timepoint [5] 0 0
Day 1 up to Day 15
Secondary outcome [6] 0 0
Mean Hourly HR 0-24 h at Day 1, 7 and 14
Timepoint [6] 0 0
Day 1 up to Day 14
Secondary outcome [7] 0 0
Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14
Timepoint [7] 0 0
Day 1 up to Day 14
Secondary outcome [8] 0 0
Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time
Timepoint [8] 0 0
Baseline (Day 1, pre-dose) up to Day 15
Secondary outcome [9] 0 0
Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time
Timepoint [9] 0 0
Baseline (Day 1, pre-dose) up to Day 15
Secondary outcome [10] 0 0
Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM
Timepoint [10] 0 0
Day 1 up to Day 15
Secondary outcome [11] 0 0
Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time
Timepoint [11] 0 0
Baseline (Day 1, pre-dose) up to Day 15
Secondary outcome [12] 0 0
Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time
Timepoint [12] 0 0
Day 1 up to Day 15
Secondary outcome [13] 0 0
Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time
Timepoint [13] 0 0
Day 1 up to Day 14
Secondary outcome [14] 0 0
Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time
Timepoint [14] 0 0
Day 1 up to Day 14
Secondary outcome [15] 0 0
Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14
Timepoint [15] 0 0
Baseline (Day 1) up to Day 14
Secondary outcome [16] 0 0
Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14
Timepoint [16] 0 0
Baseline (Day 1) up to Day 14
Secondary outcome [17] 0 0
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time
Timepoint [17] 0 0
Baseline (Day 1, pre-dose) up to Day 15
Secondary outcome [18] 0 0
Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time
Timepoint [18] 0 0
Day 1 up to Day 15
Secondary outcome [19] 0 0
Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14
Timepoint [19] 0 0
Baseline (Day 1, pre-dose) up to Day 15
Secondary outcome [20] 0 0
Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time
Timepoint [20] 0 0
Up to Follow-up (Day 17)
Secondary outcome [21] 0 0
Mean Use of Rescue Medication Over Period
Timepoint [21] 0 0
Up to Follow-up (Day 17)
Secondary outcome [22] 0 0
Number of Participants With Rescue Free Days
Timepoint [22] 0 0
Up to Follow-up (Day 17)
Secondary outcome [23] 0 0
Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14
Timepoint [23] 0 0
Baseline (Day 1, pre-dose) up to Day 14
Secondary outcome [24] 0 0
Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time
Timepoint [24] 0 0
Baseline (Day 1, pre-dose) up to Day 15
Secondary outcome [25] 0 0
Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time
Timepoint [25] 0 0
Day 1 up to Day 15
Secondary outcome [26] 0 0
AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14
Timepoint [26] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [27] 0 0
Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14
Timepoint [27] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [28] 0 0
Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14
Timepoint [28] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [29] 0 0
AUC (0-4) of CCI2189 at Day 1, 7 and 14
Timepoint [29] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [30] 0 0
Cmax of CCI2189 at Day 1, 7 and 14
Timepoint [30] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [31] 0 0
AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14
Timepoint [31] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [32] 0 0
Cmax of GW630200 and GSK932009 at Day 1, 7 and 14
Timepoint [32] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [33] 0 0
Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14
Timepoint [33] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [34] 0 0
AUC (0-4) of Salmeterol at Day 1, 7 and 14
Timepoint [34] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [35] 0 0
Cmax of Salmeterol at Day 1, 7 and 14
Timepoint [35] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)
Secondary outcome [36] 0 0
Tmax of Salmeterol at Day 1, 7 and 14
Timepoint [36] 0 0
Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

Eligibility
Key inclusion criteria
Inclusion criteria:

* females must be of non-childbearing potential
* moderately severe COPD
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Subjects with a main diagnosis of asthma
* subjects with poorly controlled COPD
* subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.

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 analysing the results/data
Intervention assignment
Parallel
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
3/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/05/2007
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Ruse
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sofia
Country [3] 0 0
Germany
State/province [3] 0 0
Baden-Wuerttemberg
Country [4] 0 0
Germany
State/province [4] 0 0
Niedersachsen
Country [5] 0 0
Germany
State/province [5] 0 0
Schleswig-Holstein
Country [6] 0 0
Netherlands
State/province [6] 0 0
Breda
Country [7] 0 0
Netherlands
State/province [7] 0 0
Hoorn
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
New Zealand
State/province [9] 0 0
Tauranga
Country [10] 0 0
Romania
State/province [10] 0 0
Bucharest
Country [11] 0 0
Romania
State/province [11] 0 0
Iasi

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 are available at https://clinicaltrials.gov/study/NCT00372112