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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007183-42 | EudraCT Number |
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This study (A7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-00610355 | Experimental |
| |
| PF - 00610355 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00610355 | Drug | 100 mcg, QD, dry powder inhaler |
| |
| PF - 00610355 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline trough (24 hours post-dose) FEV1. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in heart rate. | week 0, week 4 | |
| Change from baseline in trough FEV1. | week 4 | |
| Maximum change from baseline in FEV1 from 0 to 6 hours post-dose. |
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Inclusion Criteria:
Trough FEV1 must be 50-100% of predicted at Screening Visit 1.
Subjects who have been maintained on a stable dose of ICS over the previous month prior to screening.
Exclusion Criteria:
Subjects meeting any of the criteria of 'very poorly controlled' according to the NIH EPR 3 guidelines.
Subjects with evidence or history of cardiovascular disease including angina, myocardial, infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, atrial flutter,supraventricular tachycardia, ventricular tachycardia), systemic hypertension (SBP > 160 mmHg or DBP >100mmHg), pulmonary hypertension or cerebrovascular disease (including transient ischaemic attacks).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D001982 | Bronchial Diseases |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| C552705 | N-((4'-hydroxybiphenyl-3-yl)methyl)-2-(3-(2-((-2-hydroxy-2-(4-hydroxy-3-((methylsulfonyl)amino)phenyl)ethyl)amino)-2-methylpropyl)phenyl)acetamide |
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| Drug |
600 mcg, QD, dry powder inhaler |
|
| Placebo | Other | QD, dry powder inhaler |
|
| PF - 00610355 | Drug | 300 mcg, QD, dry powder inhaler |
|
| week 0,week 4 |
| Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score. | week 2, week 4 |
| Pharmacokinetics of PF-00610355. | week 0, week 4 |
| D007154 | Immune System Diseases |