Last updated: 11/07/2018 19:19:40
A Randomised, Double-Blind, Placebo-Controlled, Cross-Over Study to Compare the Systemic Pharmacodynamic Effects and Pharmacokinetics of Salmeterol Delivered by the Non-CFC Propellant (HFA-134a; GR106642X) and the CFCPropellant (Propellant 11/12) Metered Dose Inhalers in Healthy Subjects
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomised, Double-Blind, Placebo-Controlled, Cross-Over Study to Compare the Systemic Pharmacodynamic Effects and Pharmacokinetics of Salmeterol Delivered by the Non-CFC Propellant (HFA-134a; GR106642X) and the CFCPropellant (Propellant 11/12) Metered Dose Inhalers in Healthy Subjects
Trial description: A Randomised, Double-Blind, Placebo-Controlled, Cross-Over Study to Compare the Systemic Pharmacodynamic Effects and Pharmacokinetics of Salmeterol Delivered by the Non-CFC Propellant (HFA-134a; GR106642X) and the CFCPropellant (Propellant 11/12) Metered Dose Inhalers in Healthy Subjects
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kempsford R, Handel M., Mehta R, De Silva M, Daley-Yates P. Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects. Respiratory Medicine (2005) 99, S11-S19.
Kempsford, R., Handel, M., Mehta, R., et al. Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects. Respiratory Medicine 2005; 99: S11-9
R Kempsford, M Handel, RS Mehta, M De Silva and PT Daley-Yates. A comparative study of the safety, tolerability, pharmacodynamics and pharmacokinetics of salmeterol HFA and CFC MDI inhalers in healthy subjects. Eur Resp J 2004;24(48):582-583
Medical condition
Asthma
Product
salmeterol
Collaborators
Not applicable
Study date(s)
February 2003 to April 2003
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-03-04
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
Not applicable
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