Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Salmeterol Inhalation Powder, GSK233705, tiotropium, Fluticasone propionate, SERETIDE
Salmeterol · 14 trials · 2 indications
Baseline was the most recent result taken on or before pre-dose (Day 1). The analysis was performed using a Repeated Measures Model. This model used all available weighted mean pulse rate values recorded. Change from Baseline was calculated as (Change from Baseline = Assessment value - Baseline value).
The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose \[time 0\] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Arm 3 | EXPERIMENTAL | GSK233705 50mcg |
| Arm 4 | EXPERIMENTAL | GSK233705 100mcg |
| Arm 5 | EXPERIMENTAL | GSK233705 200mcg |
| Arm 6 | PLACEBO_COMPARATOR | Placebo |
| Long acting muscarinic receptor antagonist (LAMA) | EXPERIMENTAL | Inhaled Long acting muscarinic receptor antagonist (LAMA which is in development as a treatment for Chronic Obstructive Pulmonary Disease. |
| Long acting Beta 2 agonist (LABA) | EXPERIMENTAL | Inhaled Long Acting Beta 2 agonist (LABA) which is in development as a treatment for Chronic Obstructive Pulmonary Disease. |
| LAMA with LABA | EXPERIMENTAL | Inhaled Long Acting Muscarinic receptor Antagonist (LAMA) and a inhaled Long Acting Beta 2 Agonist (LABA), both in development for treatment of Chronic Obstructive Pulmonary Disease and taken in combination. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, no intervention. |
| LAMA | EXPERIMENTAL | After randomization subject will inhale either GSK233705 50, 100 or 200 microgram once daily for 7 days. |
| Period 1 | EXPERIMENTAL | Subjects will receive first placebo, then GSK233705, GW642444 and combination of GSK233705 and GW642444 |
| Period 2 | EXPERIMENTAL | Subjects will receive first combination of GSK233705 and GW642444, then placebo, GSK233705 and GW642444 |
| Period 3 | EXPERIMENTAL | Subjects will receive first GSK233705, then GW642444, combination of GSK233705 and GW642444 and later placebo |
| Period 4 | EXPERIMENTAL | Subjects will receive first GW642444, then combination of GSK233705 and GW642444, placebo, and later GSK233705 |
| Subjects receiving GSK233705 | EXPERIMENTAL | Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points. |
| Subjects receiving treatment sequence 1 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 1; GSK233705 20 micrograms, GSK233705 100 micrograms, tiotropium and placebo. |
| Subjects receiving treatment sequence 2 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 2; GSK233705 20 micrograms, Placebo, GSK233705 50 micrograms and tiotropium. |
| Subjects receiving treatment sequence 3 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 3; GSK233705 20 micrograms, tiotropium, Placebo and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 4 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 4; GSK233705 20 micrograms, placebo, tiotropium and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 5 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 5; Placebo, tiotropium, GSK233705 20 micrograms and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 6 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 6; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and tiotropium. |
| Subjects receiving treatment sequence 7 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 7; tiotropium, GSK233705 20 micrograms, GSK233705 50 micrograms and Placebo. |
| Subjects receiving treatment sequence 8 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 8; tiotropium, GSK233705 20 micrograms, Placebo and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 9 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 9; GSK233705 20 micrograms, tiotropium, GSK233705 50 micrograms and Placebo. |
| Subjects receiving treatment sequence 10 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 10; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and tiotropium. |
| Subjects receiving treatment sequence 11 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 11; Placebo, GSK233705 20 micrograms, tiotropium, and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 12 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 12; Tiotropium, Placebo, GSK233705 20 micrograms and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 13 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 13; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and GSK233705 100 micrograms. |
| Subjects receiving treatment sequence 14 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 14; GSK233705 20 micrograms, placebo, GSK233705 50 micrograms and GSK233705 100 micrograms. |
| Subjects receiving treatment sequence 15 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 15; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 16 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 16; GSK233705 20 micrograms, GSK233705 100 micrograms, GSK233705 50 micrograms and Placebo. |
| Name | Type | Description |
|---|---|---|
| montelukast (5mg QD) | DRUG | - |
| Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) | DRUG | - |
| Salmeterol/fluticasone propionate 50/500mcg Diskus | DRUG | - |
| Salmeterol 50mcg/ Fluticasone Propionate 500mcg | DRUG | - |
| Salmeterol/Fluticasone propionate combination product | DRUG | - |
| Fluticasone propionate | DRUG | - |
| Placebo | DRUG | matching placebo |
| GSK233705/GW642444 | DRUG | The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler. |
| GSK233705 12.5mcg | DRUG | Once daily via dry powder inhaler |
| GSK233705 25mcg | DRUG | once daily via dry powder inhaler |
| GSK233705 50mcg | DRUG | Once daily via dry powder inhaler |
| GSK233705 100mcg | DRUG | Once daily via dry powder inhaler |
| GSK233705 200mcg | DRUG | Once daily via dry powder inhaler |
| salmeterol | DRUG | - |
| tiotropium | DRUG | - |
| GSK233705 | DRUG | - |
| GSK233705 and GW642444 | DRUG | Inhaled Long acting muscarinic receptor antagonist (LAMA) and a inhaled Long acting Beta 2 agonist (LABA) both in development as treatment for Chronic Obstructive Pulmonary Disease, taken in combination. |
| GW642444 | DRUG | Inhaled Long acting Beta 2 agonist (LABA) |
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 ...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Salmeterol is used to treat asthma and chronic obstructive pulmonary disease (COPD). It is a long-acting bronchodilator studied in both conditions, including pediatric asthma and COPD maintenance. The clinical program includes trials in airway inflammation and long-term COPD survival, with enrollment across thousands of patients worldwide.
Salmeterol works as an agonist at ADRB2, the beta-2 adrenergic receptor. By activating this receptor, it produces bronchodilation and helps maintain open airways. This mechanism underlies its use in asthma and chronic obstructive pulmonary disease.
Salmeterol is developed by GSK plc, which trades under the ticker GSK. GSK has sponsored the clinical trial program for salmeterol, including studies of the salmeterol and fluticasone propionate combination product in asthma and COPD.
Salmeterol has been studied in Phase 3 clinical trials. The program includes completed Phase 3 studies in asthma and chronic obstructive pulmonary disease, as well as a completed Phase 2 study. It is an investigational and marketed respiratory therapy developed by GSK.
Salmeterol has been evaluated in completed trials including NCT00268216, a Phase 3 COPD survival study with 6,228 participants; NCT00328718, a Phase 3 pediatric asthma study comparing ADVAIR DISKUS with montelukast; NCT00268177, a Phase 3 airway inflammation study; and NCT00422604, a Phase 2 COPD study.