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Formoterol · 12 trials · 5 indications
Change from baseline in 1-hour morning post-dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24. Baseline was defined as the average of the two FEV1 values measure prior to the administration of the first dose of the IP at randomisation visit. If one of the two values was missing, the available one was used as baseline. If both values were missing, the screening pre-bronchodilator value was used. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate 12 μg at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
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To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg). Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them. Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.
FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1
| Arm | Type | Description |
|---|---|---|
| Experimental 1 | EXPERIMENTAL | Aclidinium bromide 400μg/Formoterol fumarate 12 μg |
| Experimental 2 | EXPERIMENTAL | Aclidinium bromide 400 μg |
| Comparator | ACTIVE_COMPARATOR | Formoterol fumarate 12 μg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| 1 | EXPERIMENTAL | Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose |
| 2 | EXPERIMENTAL | Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose |
| 3 | ACTIVE_COMPARATOR | Aclidinium bromide 400 μg |
| 4 | ACTIVE_COMPARATOR | Formoterol Fumarate 12 μg |
| 5 | PLACEBO_COMPARATOR | Placebo |
| Formoterol 6 μg | EXPERIMENTAL | Participants received formoterol fumarate 6 μg administered via Pressair twice daily (BID). |
| Formoterol 12 μg | EXPERIMENTAL | Participants received formoterol fumarate 12 μg administered via Pressair BID. |
| Formoterol 24 μg | EXPERIMENTAL | Participants received formoterol fumarate 24 μg administered via Pressair BID. |
| Formoterol 20 μg | EXPERIMENTAL | Participants received Perforomist inhalation solution and were instructed to take one puff from each of the two Pressair inhalers or to inhale one vial from the Perforomist 20 μg inhalation solution BID for 7 ± 1 consecutive days. |
| Formoterol 40 μg | EXPERIMENTAL | Participants received Perforomist 40 μg (2 vials of Performist 20 μg) as a single dose of administration. |
| Formoterol, then Salmeterol, then Placebo | EXPERIMENTAL | Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler |
| Salmeterol, then Palcebo, then Formoterol | EXPERIMENTAL | Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus |
| Placebo, then Formoterol, then Salmeterol | EXPERIMENTAL | Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler |
| Formoterol, then Placebo, then Salmeterol | EXPERIMENTAL | Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler |
| Salmeterol, then Formoterol, then Placebo | EXPERIMENTAL | Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler |
| Placebo, then Salmeterol, then Formoterol | EXPERIMENTAL | Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus |
| Name | Type | Description |
|---|---|---|
| Aclidinium bromide/formoterol Fixed-Dose Combination | DRUG | Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair |
| Aclidinium bromide | DRUG | Inhaled Aclidinium bromide 400 μg, twice per day via Genuair |
| Formoterol Fumarate | DRUG | Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler |
| Placebo | DRUG | Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler |
| Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) | DRUG | Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day |
| Budesonide/formoterol (Symbicort Turbuhaler) | DRUG | 2x160/4.5 microgram, inhalation, twice daily, 12 weeks |
| Formoterol (Oxis Turbuhaler) | DRUG | 2 X 4.5 microgram, inhalation, twice daily, 12 weeks |
| Formoterol (OT) | DRUG | 9 μg/dose, Inhaled, twice daily for 52 weeks |
| formoterol | DRUG | - |
| budesonide/formoterol | DRUG | - |
| Budesonide | DRUG | - |
| Terbutaline | DRUG | - |
| Formoterol fumarate (6 μg) | DRUG | Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) |
| Formoterol furmarate (20 μg) | DRUG | Oral Inhalation (via a standard jet nebulizer connected to an air compressor. |
| Placebo for formoterol fumarate | DRUG | Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) |
| Formoterol fumarate (12 μg) | DRUG | Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) |
| Formoterol fumarate (40 μg) | DRUG | Oral Inhalation (via a standard jet nebulizer connected to an air compressor. |
| Salmeterol | DRUG | Salmeterol Diskus 50 μg and Placebo Turbuhaler |
Inclusion Criteria: * 1\. Adult male or non-pregnant, non-lactating female patients aged ≥40 * 2\. Patients with a diagnosis of COPD prior to Visit 1 (screening) * 3\. Patients with moderate to severe stable COPD (Stage II or Stage III) at Visit 1: post-bronchodilator FEV1 ≥30% and \< 80% and post-...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 5 | PHASE3 | Depemokimab |
| Sanofi SA Sponsored ADR | SNY | 7 | PHASE3 | Itepekimab |
| AstraZeneca PLC | AZN | 14 | PHASE3 | Tezepelumab |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Alpha-1 MP |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07275315 dose 1 |
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Frespaciguat |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE3 | 611 |
| Generate Biomedicines, Inc. | GENB | 1 | PHASE1 | GB-0895 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | Treprostinil |
| Pulmonx Corp. | LUNG | 3 | - | Undisclosed |
| Baxter International Inc. | BAX | 1 | N/A | Undisclosed |
| Catalyst Pharmaceuticals, Inc. | CPRX | 1 | EARLY_PHASE1 | Undisclosed |
Formoterol is a small molecule respiratory drug used for chronic obstructive pulmonary disease (COPD) and asthma, including stable asthma. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical development for these indications.
Formoterol is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is being studied for the treatment of respiratory conditions including COPD and asthma.
Formoterol is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The development program includes completed Phase 3 trials in asthma and COPD.
Formoterol has been studied in several clinical trials, including NCT00651547 (SEEDLING), NCT00651651 (SPRUCE 80/4.5), NCT00652002 (SPRUCE 160/4.5), and NCT00658255. These trials were completed and enrolled a total of 1,480 patients with asthma or stable asthma.
Formoterol is a component of Symbicort, a combination product. Clinical trials such as NCT00651547 and NCT00651651 evaluated Symbicort, which contains formoterol, in asthmatic patients. Formoterol is also administered alone via devices like Oxis Turbuhaler.