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This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. Male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will be a wash-out period of at least 5 days between doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Subjects will receive GW685698X 800 microgram (mcg) single inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. |
|
| Treatment 2 | Experimental | Subjects will receive GW685698X 800 mcg containing magnesium stearate inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW685698X | Drug | GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days | Vital signs: for 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma GW685698X concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) following single inhaled doses in mild/moderate asthmatic patients for 48 hours. Weighted mean serum cortisol (0-24 h) on Day 1. | following single inhaled doses in mild/moderate asthmatic patients for 48 hours. |
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Inclusion criteria:
Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
screening pre-bronchodilator FEV1 >or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of >or= 12.0% over the max of the three screening measures and an absolute change of
>or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria),
BMI 19-31 kg/m2,
Non-smoker,
refrains from use of prohibited medication within the specified timeframes
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wellington | 6035 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| HZA108799 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| GW685698X containing magnesium stearate | Drug | GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS |
|
| Results for study HZA108799 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| HZA108799 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA108799 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA108799 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA108799 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA108799 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| HZA108799 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |