Last updated: 11/04/2018 05:39:56
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multi-enter, randomized, double-blind, placebo-controlled, four-way incomplete block crossover study to examine efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat administration of three inhaled doses (10, 15, and 20 mcg) of GSK159797
Trial description: This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline in the mean of the 23 and 24 hour clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in 1 second (FEV1) after repeat dosing for 14 days.
Timeframe: Baseline (pre-dose on Day 1) and Day 14
Secondary outcomes:
Mean change from Baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 after a single dose (Day 1)
Timeframe: Baseline (pre-dose on Day 1) and 23 and 24 hour post-dose on Day 1
Mean change from Baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Day 7
Timeframe: Baseline (pre-dose on Day 1) and Day 7
Change from Baseline in weighted mean clinic FEV1 over 0-2 hours, 0-4 hours and 0-24 hours on Day 1 and Day 14
Timeframe: Baseline (pre-dose on Day 1) and 0-2 hours, 0-4 hours and 0-24 hours on Day 1 and Day 14
Mean change from Baseline in morning (AM) Peak expiratory flow rate (PEFR) from electronic flow meter over Days 2-15
Timeframe: Baseline (pre-dose on Day 1) and Day 2 to Day 15
Mean change from Baseline in evening (PM PEFR) from electronic flow meter over Days 1-14
Timeframe: Baseline (pre-dose on Day 1) and 12 and 13 hour post-dose on Day 1 to Day 14
Mean change from Baseline in AM FEV1 from electronic flow meter over Days 2-15
Timeframe: Baseline (pre-dose on Day 1) and Day 2 to Day 15
Mean change from Baseline in PM FEV1 from electronic flow meter over Days 1-14.
Timeframe: Baseline (pre-dose on Day 1) and 12 and 13 hour post-dose on Day 1 to Day 14
Interventions:
Drug: GSK159797 (10, 15, and 20mcg)
Drug: salbutamol
Drug: salmeterol 50mcg
Drug: placebo
Enrollment:
54
Observational study model:
Not applicable
Primary completion date:
2007-24-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
milveterol, salmeterol
Collaborators
Not applicable
Study date(s)
April 2006 to January 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 70 years
Accepts healthy volunteers
No
- Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
- Female subjects only using acceptable birth control method
- Past or present disease conditions
- Normal screening Holter ECG
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
- Female subjects only using acceptable birth control method
- Non-smokers
- FEV1 between 60 and 90% predicted
- Increase in FEV1 12% or greater and 300mL and greater after salbutamol use
Exclusion criteria:
- Past or present disease conditions
- Normal screening Holter ECG
- Respiratory tract infection within 4 weeks of screening
- History of life threatening asthma
- Previous use of COA
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-24-01
Actual study completion date
2007-24-01
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.
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