Last updated: 11/04/2018 09:00:51

Optimising the propranolol block model

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GSK study ID
MAB104954
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Clinicaltrials.gov ID
NCT00549120
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A study to optimise the propranolol block model for assessment of the pharmacological activity of bronchodilators in healthy volunteers.
Trial description: Optimising the propranolol block model
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Specific airway conductance (sGAW)

Timeframe: Pre-dose and up to 26 h post-dose

Secondary outcomes:

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

Timeframe: Study duration

Propranolol pharmacokinetics

Timeframe: Pre-dose and up to 28 h post-dose

Interventions:
  • Drug: Propranolol
  • Drug: Salbutamol
  • Drug: Ipratropium
  • Drug: Placebo
    • Enrollment:
    18
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    salbutamol
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to October 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Healthy adult male or female aged between 18 and 50 years.
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-26-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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