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salmeterol

Phase 3

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Last Updated: Jan 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment6,418

FDA Designations

No designations recorded

Clinical trial landscape

salmeterol · 3 trials · 1 indication

Phase 3 2Phase 2 1
NCT00268177Airway Inflammation In Patients With Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic Obstructive
COMPLETED130 Analytics
NCT00268216Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)Pulmonary Disease, Chronic Obstructive
COMPLETED6,228 Analytics
PHASE3COMPLETED
Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics
PHASE3COMPLETED
Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

To compare the number of CD68+ and CD8+ inflammatory cells per area of biopsy tissue and the percentage and total number of neutrophils in induced sputum between salmeterol/fluticasone propionate and placebo
All cause mortality at 3 years
Bronchodilator effect of GSK233705 plus salmeterol at day 7, compared with placebo in COPD subjects.

Secondary Endpoints

To compare the number of mast cells, CD45+,CD4+,IFN-gamma mRNA+,TNF-alpha mRNA+, per area of biopsy and the percentage and number of macrophages, eosinophils, lymphocytes in induced sputum between salmeterol/fluticasone propionate and placebo
Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.
Bronchodilator effect of salmeterol alone and tiotropium alone compared with placebo and GSK233705 at day 7. Safety and tolerability of GSK233705 plus salmeterol and the 2 active comparators at day 7.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Salmeterol/fluticasone propionate 50/500mcg DiskusDRUG -
Salmeterol 50mcg/ Fluticasone Propionate 500mcgDRUG -
salmeterolDRUG -
tiotropiumDRUG -
GSK233705DRUG -
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Established clinical history of chronic obstructive airways disease. * Must be current or ex-smokers with a smoking history of at least 10 pack-years (e.g. 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years). * Must have reduced lung function, defined as a Forced...

Countries:DenmarkEstoniaFinlandItalyLithuaniaSlovakiaSpainUnited KingdomUnited StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCroatiaCzechiaFranceGermanyGreeceHong KongHungaryIcelandLatviaMalaysiaMexicoNetherlandsNew ZealandNorwayPakistanPhilippinesPolandPuerto RicoRomaniaRussiaSingaporeSouth AfricaSwedenTaiwanThailandUkraine
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Frequently asked questions about salmeterol

What is salmeterol used for in COPD?

Salmeterol is a small molecule being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It has been evaluated in clinical trials involving patients with this condition, with studies conducted across multiple countries. The drug is in clinical development for respiratory use.

Who makes salmeterol?

Salmeterol is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this drug for the treatment of Chronic Obstructive Pulmonary Disease.

What phase is salmeterol in?

Salmeterol has completed Phase 3 clinical trials for Chronic Obstructive Pulmonary Disease. The drug is investigational and has been studied in clinical development programs. It has not been described as approved, and it remains in clinical research.

What clinical trials is salmeterol in?

Salmeterol has been studied in three completed clinical trials. These include NCT00268177, which examined airway inflammation in COPD patients, and NCT00268216, which evaluated survival in subjects with COPD. A third trial, NCT00422604, assessed safety and efficacy of salmeterol in combination with another investigational drug.

Is salmeterol the same as GSK233705?

Salmeterol is not the same as GSK233705. In one clinical trial, NCT00422604, salmeterol was studied in combination with GSK233705, which is a separate investigational compound. The trial compared this combination against other treatments in patients with COPD.