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Label indication SINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). FDA label
Also known as Singulair
GW274150 · 5 trials · 4 indications
Power Doppler ultrasonographic measurement of synovial vascularity
| Arm | Type | Description |
|---|---|---|
| GW274150 60 mg once daily for 28 days | EXPERIMENTAL | 60 mg GW274150 taken once daily for 28 days |
| Prednisolone 7.5 mg once daily for 28 days | ACTIVE_COMPARATOR | 7.5 mg prednisolone taken once daily for 28 days |
| Placebo once daily for 28 days | PLACEBO_COMPARATOR | Placebo taken once daily for 28 days |
| Arm 1 | EXPERIMENTAL | GW274150 - 5mg or 30mg |
| Arm 2 | PLACEBO_COMPARATOR | Placebo to match GW274150 |
| Sequence 1 | EXPERIMENTAL | Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3. |
| Sequence 2 | EXPERIMENTAL | Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3. |
| Sequence 3 | EXPERIMENTAL | Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3. |
| Sequence 4 | EXPERIMENTAL | Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3. |
| Sequence 5 | EXPERIMENTAL | Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3. |
| Sequence 6 | EXPERIMENTAL | Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3. |
| Name | Type | Description |
|---|---|---|
| GW274150 | DRUG | 60 mg /day |
| Prednisolone | DRUG | 7.5 mg/day |
| Placebo | OTHER | Placebo |
| Singulair | DRUG | Singulair will be available as over encapsulated 10 mg orange tablets. |
Inclusion criteria: * Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology * Female subjects who are not capable of becoming pregnant * Active disease defined as Disease Activity Score (DAS) 28 = 4.0 and at least one metacarpal-phalangeal ...
GW274150 is an investigational small molecule drug developed by GSK plc for inflammatory and neurological conditions. It has been studied in rheumatoid arthritis, asthma, and acute migraine. It is a selective inhibitor of NOS2, also known as inducible nitric oxide synthase. GW274150 remains in clinical development and is not approved for any indication.
GW274150 has been studied for rheumatoid arthritis, asthma, and acute migraine disorders. Clinical trials enrolled adults with these conditions, including a Phase 2 trial in acute migraine and Phase 2 studies in rheumatoid arthritis. It is an investigational agent and has no approved use.
GW274150 targets NOS2, the inducible nitric oxide synthase enzyme. It acts as an inhibitor of this target, aiming to reduce nitric oxide production associated with inflammation. This mechanism was explored across rheumatoid arthritis, asthma, and migraine studies conducted by GSK.
GW274150 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials evaluating the compound in rheumatoid arthritis, asthma, and migraine. The drug is an internally developed small molecule NOS2 inhibitor.
GW274150 is in Phase 2 clinical development. It has completed Phase 2 trials in rheumatoid arthritis and acute migraine, plus a Phase 1 study in mild asthma. It is investigational and has not been approved by the FDA for any indication.
Completed trials include NCT00379990 and NCT00370435 in rheumatoid arthritis, NCT00319137 in acute migraine, and NCT00273013 in mild asthma. All four studies are completed, with no active trials. The trials were randomized, double blind, and placebo controlled, enrolling 556 participants in total.