Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma

NCT00354666 | Completed Phase 2

• 1 other identifier: B2E101312
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was designed to test safety aspects and effects on lung function of a new dry powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with previous studies which have only used inhalation of the drug as a vapour.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

inhaled; asthmatic subjects; GSK159797; safety and tolerability; efficacy; dry powder

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.

Secondary Outcomes (1)

• Effects on the lung at 12 and 24hrs Effects on the heart, blood pressure and pulse rate at 8hrs Changes in the amount of glucose and potassium in the blood 4 and 8hrs Amount of drug in the body (blood and urine).

Interventions

GSK159797 DRUG

Eligibility Criteria

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

You may qualify if:

• Subjects with mild to moderate stable asthma but no other lung problems.
• Male subjects or females who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
• Non-smokers.
• Subjects that show a measurable improvement in the function of their lungs after a single dose of salbutamol.

You may not qualify if:

• Any significant illness.
• Subjects with heart problems.
• Subjects who have had a cold or chest infection 2-4 weeks prior to the study.
• Subjects who take medication for their asthma, or other conditions, not compatible with the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

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; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: September 1, 2004
• Study Completion: December 1, 2004
• Last Updated: September 1, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share