A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT00372112 | Completed Phase 2 Results

• 1 other identifier: B2C108562
• Study Type: interventional
• Target: 68
• Locations: 6 countries
• Sites: 14

Brief Summary

The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease (COPD); COPD

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

  An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

  Up to Follow-up (17 days)

Secondary Outcomes (36)

• 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

  Baseline (Day 1, pre-dose) up to Day 14

• 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

  Baseline (Day 1, pre-dose) up to Day 15

• Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14

  Baseline (Day 1, pre-dose) up to Day 15

• 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

  Baseline (Day 1, pre-dose) up to Day 15

• 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

  Day 1 up to Day 15

Study Arms (4)

100 mcg GW642444H

ACTIVE COMPARATOR

Twice daily in the morning.

Drug: GW642444

400 mcg GW642444H

ACTIVE COMPARATOR

Twice daily in the morning.

Drug: GW642444

50 mcg salmeterol

ACTIVE COMPARATOR

Twice daily.

Drug: GW642444

placebo

PLACEBO COMPARATOR

Twice daily

Drug: GW642444; Other: Placebo

Interventions

GW642444 DRUG

GW642444H

100 mcg GW642444H; 400 mcg GW642444H; 50 mcg salmeterol; placebo

Placebo OTHER

Placebo administered twice daily

placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• females must be of non-childbearing potential
• moderately severe COPD

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

GSK Investigational Site

Rousse, 7000, Bulgaria

Location

GSK Investigational Site

Sofia, 1431, Bulgaria

Location

GSK Investigational Site

Sofia, 1606, Bulgaria

Location

GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

Location

GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

Location

GSK Investigational Site

Breda, 4819 EV, Netherlands

Location

GSK Investigational Site

Hoorn, 1624 NP, Netherlands

Location

GSK Investigational Site

Auckland, 1005, New Zealand

Location

GSK Investigational Site

Tauranga, New Zealand

Location

GSK Investigational Site

Bucharest, 050159, Romania

Location

GSK Investigational Site

Iași, 700506, Romania

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2006
• First Posted: September 6, 2006
• Study Start: November 3, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 10, 2007
• Last Updated: April 2, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (2); DE (3); AU (2); NZ (2); RO (2); BU (3)