Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- Healthy adult male or female aged between 18 and 50 years.
- Body mass index within the range 19-29.9 kilograms/metre2
- 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
Inclusion and 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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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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