Propranolol Enabling Study - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00549120

Purpose

Propranolol Enabling Study

Condition	Intervention
Healthy Subjects	Drug: propranolol

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	A Study to Optimise the Propranolol Block Model for Assessment of the Pharmacological Activity of Bronchodilators in Healthy Volunteers.

Resource links provided by NLM:

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Enrollment:	16
Study Start Date:	August 2007

Intervention Details:

Other Name: propranolol

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult males or female aged between 18 and 50 years.
Body mass index within the range 19-29.9 kilograms/metre2
Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7
The subject has an increase in sGAW of >% over pre-dose baseline within 2 h of administration of 400 ug salbutamol by MDI inhaler at screening or in the 3 months before screening.
subject has an increase in sGaw of ?25% over pre-dose baseline within 2 h following 40 ug ipratropium bromide at screening or in the 3 months before screening
subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.

Exclusion criteria:

who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
history of respiratory disease
significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec
supine mean heart rate outside the range 45-90 beats per minute (bpm) at screening.
subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 1 month
infected with the Hepatitis B, Hepatitis C, or HIV virus
subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549120

Locations

United Kingdom
GSK Investigational Site
London, United Kingdom

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD MDsc FFPM

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00549120 History of Changes
Other Study ID Numbers:	MAB104954
Study First Received:	October 23, 2007
Last Updated:	October 9, 2008
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by GlaxoSmithKline:

B-agonist,
b-antagonist,
propranolol

Additional relevant MeSH terms:

Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists

Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012