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Salmeterol

Phase 3

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Jan 20, 2017

Target and mechanism

ModalitySmall molecule

Also known as salmeterol 50mcg, Salmeterol 50mcg, salmeterol and fluticasone propionate, Salmeterol Inhalation Powder

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment726

FDA Designations

No designations recorded

Clinical trial landscape

Salmeterol · 5 trials · 2 indications

Phase 3 4Phase 2 1
NCT00328718Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable TabletsAsthma
COMPLETED526 Analytics
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
NCT00158834Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma MedicationsAsthma
COMPLETED200 Analytics
PHASE3COMPLETED
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
AsthmaUnlock trial 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
PHASE3COMPLETED
Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
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
Asthma symptom free days during the last 12 weeks of the treatment period.
Bronchodilator effect of GSK233705 plus salmeterol at day 7, compared with placebo in COPD subjects.

Secondary Endpoints

Changes from baseline to endpoint of:morning pre-dose FEV1 (Forced expiratory volume) symptom free 24 hour-periods rescue medication-free 24 hour-periods mean evening PEFR
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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
montelukast (5mg QD)DRUG -
Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)DRUG -
Salmeterol/fluticasone propionate 50/500mcg DiskusDRUG -
Salmeterol 50mcg/ Fluticasone Propionate 500mcgDRUG -
Salmeterol/Fluticasone propionate combination productDRUG -
Fluticasone propionateDRUG -
salmeterolDRUG -
tiotropiumDRUG -
GSK233705DRUG -
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Eligibility Criteria

Age Range6 Years to 14 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion criteria: * Diagnosis of asthma for at least 6 months (per American Thoracic Society \[ATS\] definition). * Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal. * More than or 12% FEV1 reversibility following inhalation of salbutamol. * Must also be ...

Countries:ArgentinaColombiaCosta RicaMexicoPeruTurkey (Türkiye)VenezuelaDenmarkEstoniaFinlandItalyLithuaniaSlovakiaSpainUnited KingdomUnited StatesAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCroatiaCzechiaFranceGermanyGreeceHong KongHungaryIcelandLatviaMalaysiaNetherlandsNew 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.