NCT00749411

Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD

Completed Phase 2 Results posted Last updated 1 September 2020

What this trial tests

Phase 2 trial testing Placebo in Pulmonary Disease, Chronic Obstructive in 61 participants. Completed in 12 February 2009.

Timeline

13 November 2008

Primary endpoint
12 February 2009

12 February 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	61
Start date	13 November 2008
Primary completion	12 February 2009
Estimated completion	12 February 2009
Sites	12 locations across United States

Drugs / interventions tested

• Placebo
• GSK233705/GW642444 — full drug profile →

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 40 to 80, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at Day 28. Primary · Baseline (Pre-dose, Day 1) and Day 28

Baseline was the most recent result taken on or before pre-dose (Day 1). The analysis was performed using a Repeated Measures Model. This model used all available weighted mean pulse rate values recorded. Change from Baseline was calculated as (Change from Baseline = Assessment value - Baseline value).

Group	Value	95% CI
Placebo	-3.8	± 1.78
GSK233705/GW642444	-4.8	± 1.32

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · On-treatment; from treatment start until one day after treatment stop (Up to Day 29)

AE was 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. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when,

Any AE

Group	Value	95% CI
Placebo	8
GSK233705/GW642444	10

Any SAE

Group	Value	95% CI
Placebo	0
GSK233705/GW642444	0

Adverse events — posted to ClinicalTrials.gov

Time frame: On-treatment; from treatment start until one day after treatment stop (Up to Day 29). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/21 (0%)

Deaths: 0/21

GSK233705/GW642444

Serious: 0/40 (0%)

Deaths: 0/40

Other adverse events (22 terms — click to expand)

Reaction	System	Placebo	GSK233705/GW642444
Dry throat	Respiratory, thoracic and mediastinal disorders	—	—
Dysgeusia	Nervous system disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Viral infection	Infections and infestations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Postnasal drip	Respiratory, thoracic and mediastinal disorders	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Chest pain	General disorders	—	—
Oedema peripheral	General disorders	—	—
Joint sprain	Injury, poisoning and procedural complications	—	—
Muscle injury	Injury, poisoning and procedural complications	—	—
Blood glucose increased	Investigations	—	—
Gamma-glutamyltransferase increased	Investigations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Joint stiffness	Musculoskeletal and connective tissue disorders	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Venous thrombosis limb	Vascular disorders	—	—

Data from ClinicalTrials.gov NCT00749411 adverse events section.

Sponsor's own description

The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.