Optimising the Propranolol Block Model

NCT00549120 | Completed Phase 1

• 1 other identifier: MAB104954
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Optimising the propranolol block model

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Healthy Subjects; muscarinic receptor antagonist; propranolol; beta-blocker; beta-agonist

Outcome Measures

Primary Outcomes (1)

• Specific airway conductance (sGAW)

  Pre-dose and up to 26 h post-dose

Secondary Outcomes (2)

• Tolerability: adverse events, 12 lead ECG, blood pressure and heart rate

  Study duration

• Propranolol pharmacokinetics

  Pre-dose and up to 28 h post-dose

Study Arms (6)

Propranolol alone

EXPERIMENTAL

Propranolol 80 mg (5 doses at 6 hourly intervals)

Drug: Propranolol

Propranolol + salbutamol

EXPERIMENTAL

Propranolol 80 mg (5 doses at 6 hourly intervals) + salbutamol 600 μg (4 doses at 6 hourly intervals)

Drug: Propranolol; Drug: Salbutamol

Salbutamol alone

EXPERIMENTAL

Salbutamol 600 μg (4 doses at 6 hourly) + placebo (5 doses at 6 hourly intervals)

Drug: Salbutamol; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo (5 doses at 6 hourly)

Drug: Placebo

Propranolol + ipratropium + salbutamol

EXPERIMENTAL

Propranolol 80 mg (2 doses at 6 hourly intervals) + ipratropium bromide 40 μg (2 doses at 6 hourly interval) + salbutamol 600 μg (1 dose)

Drug: Propranolol; Drug: Salbutamol; Drug: Ipratropium

Placebo + ipratropium + salbutamol

EXPERIMENTAL

Placebo (2 doses at 6 hourly intervals) + ipratropium bromide 40 μg (2 doses at 6 hourly interval) + salbutamol 600 μg (1 dose)

Drug: Salbutamol; Drug: Ipratropium; Drug: Placebo

Interventions

Propranolol DRUG

40 mg tablets

Propranolol + ipratropium + salbutamol; Propranolol + salbutamol; Propranolol alone

Salbutamol DRUG

Metered dose inhaler (600 μg)

Placebo + ipratropium + salbutamol; Propranolol + ipratropium + salbutamol; Propranolol + salbutamol; Salbutamol alone

Ipratropium DRUG

Metered dose inhaler (40 μg)

Placebo + ipratropium + salbutamol; Propranolol + ipratropium + salbutamol

Placebo DRUG

Placebo for propranolol tablets

Placebo; Placebo + ipratropium + salbutamol; Salbutamol alone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, United Kingdom

Location

Related Links

• Results for study MAB104954 can be found on the GSK Clinical Study Register.
• 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

Interventions

Propranolol; Albuterol; Ipratropium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Ethanolamines; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 25, 2007
• Study Start: August 15, 2007
• Primary Completion: October 26, 2007
• Study Completion: October 26, 2007
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)