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salmeterol xinafoate

Phase 3

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Last Updated: Apr 15, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

salmeterol xinafoate · 1 trial · 1 indication

Phase 3 1
NCT00269126Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)Pulmonary Disease, Chronic Obstructive
COMPLETED150 Analytics
PHASE3COMPLETED
Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg

Secondary Endpoints

Change in morning PEF
Changes in pre-dose FVC, V50, V25
Use of rescue medication
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
fluticasone propionate/salmeterol combination DISKUSDRUG -
salmeterol xinafoateDRUG -
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Diagnosis of COPD. Exclusion criteria: * Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD. * Other inclusion and exclusion criteria will be evaluated at the first study visit.

Countries:Japan
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Frequently asked questions about salmeterol xinafoate

What is salmeterol xinafoate used for in chronic obstructive pulmonary disease?

Salmeterol xinafoate is used for the treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is a small molecule respiratory therapy developed by GSK plc. The drug has been evaluated in a Phase 3 clinical trial for this condition.

What does salmeterol xinafoate target?

Salmeterol xinafoate is a long-acting beta2-adrenergic agonist that targets beta2-adrenergic receptors in the airways. By stimulating these receptors, it promotes bronchodilation, which helps to open up the airways and improve breathing in patients with chronic obstructive pulmonary disease.

Who makes salmeterol xinafoate?

Salmeterol xinafoate is developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company has conducted clinical trials to evaluate the drug's safety and efficacy in patients with chronic obstructive pulmonary disease.

What phase is salmeterol xinafoate in?

Salmeterol xinafoate is in Phase 3 clinical development. It has completed a Phase 3 trial for chronic obstructive pulmonary disease, but it remains an investigational drug and has not been approved for this indication. The completed trial involved 150 participants in Japan.

What clinical trials is salmeterol xinafoate in?

Salmeterol xinafoate has been studied in one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT00269126. This trial evaluated the drug for chronic obstructive pulmonary disease in 150 patients aged 40 years and older in Japan. The study was randomized and double-blind.

Is salmeterol xinafoate the same as salmeterol?

Salmeterol xinafoate is a salt form of salmeterol, a long-acting beta2-adrenergic agonist. The xinafoate salt is used to improve the drug's stability and delivery. In clinical use, salmeterol xinafoate is often referred to simply as salmeterol, but they are chemically related compounds.