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This study was designed to look at safety aspects and effects of repeat inhaled doses of GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (COPD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Part A | Experimental | Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo. |
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| Cohort 2: Part A | Experimental | Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo. |
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| Part B | Experimental | Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW870086X | Drug | Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in lung function 2 hours after treatment on day 7 | on day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lung function 14 and 26 hours after treatment on day 7; Change in lung function 2 hours after treatment on day 1; Effects on blood and urine tests; effects on the heart, pulse rate and blood pressure; effects on the lungs | 2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7; |
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Inclusion criteria:
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 | Manchester | Lancashire | M23 9LT | United Kingdom | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study SIG102335 can be found on the GSK Clinical Study Register. | View source |
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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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| ID | Term |
|---|---|
| C581038 | GW870086X |
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| Placebo | Drug | Placebo matching GW870086X will be administered by subjects |
|
| London |
| SE5 8AF |
| United Kingdom |
| GSK Investigational Site | London | United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |