Last updated: 07/17/2024 15:07:39
Pharmacokinetics and PharmacoDynamics of GW685698 in Paedeatric asthmatic patients
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, double-blind, placebo-controlled, two-way crossover 14-day study to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of repeat dose inhaled fluticasone furoate 100ug (micrograms) in children aged 5-11 years with persistent asthma
Trial description: This study will investigate the effect of dosing with flutucasone furoate in asthmatic subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and serum cortisol levels.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with any adverse event (AE) or any serious adverse event (SAE) during the Treatment Period
Timeframe: From the start of study medication until Week 11 (Visit 6)/Early Withdrawal
Basophil, eosinophil, lymphocyte, monocyte, total neutrophil, platelet, and white blood cell count values at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Hemoglobin and mean corpuscle hemoglobin concentration (MCHC) values at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Reticulocyte and Red Blood Cell (RBC) values at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Hematocrit values at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Mean Corpuscle Volume (MCV) value at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Mean Corpuscle Hemoglobin (MCH) values at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Alanine amino transferase (ALT), alkaline phosphatase (ALP), aspartate amino transferase (AST), and gamma glutamyl transferase (GGT) values at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Albumin and total protein values at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Calcium, chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) values at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Total bilirubin, creatinine, and uric acid values at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period (up to Study Day 44)
Peak expiratory flow on Day 1 and Day 14 of the respective treatment period
Timeframe: Day 1 and Day 14 of the respective treatment period (up to Study Day 44)
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and Day 14 of the respective treatment period
Timeframe: Baseline and Day 14 of the respective treatment period (up to Study Day 44)
Heart rate at Baseline and Day 14 of the respective treatment period
Timeframe: Baseline and Day 14 of the respective treatment period (up to Study Day 44)
Change from Baseline in the indicated electrocardiographic (ECG) parameters at the indicated time points on Day 14 of the respective treatment period
Timeframe: Baseline and Day 14 of the respective treatment period (up to Study Day 44)
Secondary outcomes:
AUC(0-t) on Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period
Cmax on Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period
tmax and t at Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period
Serum cortisol weighted mean (0–12 hours) on Day 14 of the respective treatment period
Timeframe: Day 14 of the respective treatment period
Average oropharyngeal cross-sectional area on Days 1 and 14 of the respective treatment period
Timeframe: Days 1 and 14 of the respective treatment period
Distance of assessment on Days 1 and 14 of the respective treatment period
Timeframe: Days 1 and 14 of the respective treatment period
Oropharyngeal volume on Days 1 and 14 of the respective treatment period
Timeframe: Days 1 and 14 of the respective treatment period
Average flow rate and Peak Inspiratory Flow Rate (PIFR) on Days 1 and 14 of the respective treatment period
Timeframe: Day 1 and Day 14 of the respective treatment period
Inhalation time on Days 1 and 14 of the respective treatment period
Timeframe: Day 1 and Day 14 of the respective treatment period
Inhaled volume on Days 1 and 14 of the respective treatment period
Timeframe: Day 1 and Day 14 of the respective treatment period
Peak pressure drop on Days 1 and 14 of the respective treatment period
Timeframe: Day 1 and Day 14 of the respective treatment period
Total emitted dose (TED) on Days 1 and 14 of the respective treatment period
Timeframe: Day 1 and Day 14 of the respective treatment period
Ex-throat dose (ETD) and ETD <2 microns on Days 1 and 14 of the respective treatment period
Timeframe: Day 1 and Day 14 of the respective treatment period
Interventions:
Enrollment:
27
Primary completion date:
2011-29-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Oliver A, Allen A, VanBuren S, Hamilton M, Tombs L, Kempsford R, Qaqundah P.Safety, tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate, a novel inhaled corticosteroid, in children aged 5–11 years with persistent asthma: a randomized trial.Clin Pharmacol Drug Devel.2014;3(2):144-50
Medical condition
Asthma
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
May 2010 to January 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
5 - 11 years
Accepts healthy volunteers
No
- Male and pre-menarchial female subjects aged 5–11 years on the last planned treatment day are eligible for this study. Pre-menarchial females are defined as any female who has yet to begin menses and is considered Tanner Stage 2 or less.
- Diagnosis of asthma at least 6 months prior to screening.
- Subjects who have changed their asthma medication within 4 weeks of screening or subjects currently being treated with inhaled corticosteroids or have received such treatment within 4 weeks of screening. In addition, subjects currently receiving (or have received within 4 weeks of screening) any of the following asthma therapies: theophyllines, long-acting inhaled beta-agonists or oral beta-agonists.
- Any medical condition or circumstance making the volunteer unsuitable for participation in the study (e.g. history of life-threatening asthma).
Inclusion and exclusion criteria
Inclusion criteria:
- Male and pre-menarchial female subjects aged 5–11 years on the last planned treatment day are eligible for this study. Pre-menarchial females are defined as any female who has yet to begin menses and is considered Tanner Stage 2 or less.
- Diagnosis of asthma at least 6 months prior to screening.
- Patients must be controlled on their existing asthma treatment at screening as defined by a Childhood Asthma Control Test score of >19 and PEF (Peak Expiratory Flow) ≥80% predicted.
- Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no other significant medical conditions.
- Subjects must be taking a stable regimen of a short acting beta-agonist inhaler on an as-need basis for at least 4 weeks prior to screening.
- Subjects must weigh at least 15 kg (kilograms).
- Subjects must demonstrate ability to accept and effectively use the fluticasone furoate devices using the demonstration kits provided to the site.
- Subjects and parents/guardians must be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. Parents/guardians must have the ability to read, write and record diary information collected throughout the study. They must also have the ability to manage study drug administration and PEF assessments.
- A signed and dated written informed consent from at least one parent/guardian, and accompanying informed assent from the subject prior to admission to the study.
Exclusion criteria:
- Subjects who have changed their asthma medication within 4 weeks of screening or subjects currently being treated with inhaled corticosteroids or have received such treatment within 4 weeks of screening. In addition, subjects currently receiving (or have received within 4 weeks of screening) any of the following asthma therapies: theophyllines, long-acting inhaled beta-agonists or oral beta-agonists.
- Any medical condition or circumstance making the volunteer unsuitable for participation in the study (e.g. history of life-threatening asthma).
- Any clinically relevant abnormality identified on the screening medical assessment, including asthma exacerbation requiring systemic corticosteroids (oral, intramuscular, intravenous) or emergency room attendance within 3 months or asthma exacerbation requiring hospitalization within 6 months prior to screening.
- Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject’s asthma status or the subject’s ability to participate in the study.
- Clinical visual evidence of oral candidiasis at screening.
- Parent/guardian has history of psychiatric disease, intellectual deficiency, substance abuse, or other condition (e.g., inability to read, comprehend and write) which will limit the validity of consent to participate in this study.
- Any adverse reaction including immediate or delayed hypersensitivity to any beta-2-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid therapy.
- Known or suspected sensitivity to the constituents of the novel dry powder inhaler (i.e., lactose or magnesium stearate), for example, history of severe milk protein allergy.
- A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
- Children who are wards of the state or government.
- Evidence of clinically significant abnormality in the 12-lead ECG (electrocardiogram) at screening.
Trial location(s)
Location
GSK Investigational Site
Cypress, California, United States, 90630
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Study documents
Study report synopsis
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
Study complete
Actual primary completion date
2011-29-01
Actual study completion date
2011-29-01
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.
Additional information about the trial
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