Optimising the Propranolol Block Model

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00549120
• Date of registration: 23/10/2007
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Optimising the Propranolol Block Model
• Scientific title: A Study to Optimise the Propranolol Block Model for Assessment of the Pharmacological Activity of Bronchodilators in Healthy Volunteers.
• Date of first enrolment: August 15, 2007
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00549120
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy adult male 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:

- 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Drug: Ipratropium

Drug: Propranolol

Drug: Placebo

Drug: Salbutamol

Primary Outcome(s)

Specific airway conductance (sGAW) [Time Frame: Pre-dose and up to 26 h post-dose]

Secondary Outcome(s)

Propranolol pharmacokinetics [Time Frame: Pre-dose and up to 28 h post-dose]

Tolerability: adverse events, 12 lead ECG, blood pressure and heart rate [Time Frame: Study duration]

Secondary ID(s)

MAB104954

Source(s) of Monetary Support

Please refer to primary and secondary sponsors