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Mometasone Furoate Metered Dose Inhaler · 1 trial · 1 indication
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.
| Arm | Type | Description |
|---|---|---|
| MF MDI 50 mcg BID | EXPERIMENTAL | Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks. |
| MF MDI 100 mcg BID | EXPERIMENTAL | Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| MF MDI 200 mcg BID | EXPERIMENTAL | Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| MF DPI 100 mcg QD | ACTIVE_COMPARATOR | Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg | DRUG | MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks |
| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg | DRUG | MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks |
| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg | DRUG | MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks |
| Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg | DRUG | MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks |
| Placebo Metered Dose Inhaler (MDI) | DRUG | Placebo MDI, 2 puffs BID for 12 weeks |
| Placebo Dry Powder Inhaler (DPI) | DRUG | Placebo DPI, 1 puff QD for 12 weeks |
Inclusion Criteria: * Diagnosis of asthma of at least 6 months duration. * Using an Inhaled corticosteroid (ICS), either alone or in combination with a long-acting beta-2 agonist (LABA), for at least 12 weeks prior to the Screening Visit and must have been on a stable asthma regimen for at least 2 ...
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 |
Mometasone furoate metered dose inhaler is an investigational inhaled therapy being studied for the treatment of asthma. The clinical program has focused on children with persistent asthma, a form of the disease that requires ongoing controller therapy rather than occasional rescue treatment.
Organon & Co. is developing mometasone furoate metered dose inhaler. Organon trades on the New York Stock Exchange under the ticker OGN. The company is the sponsor of the clinical program evaluating this inhaled formulation in pediatric asthma.
Mometasone furoate metered dose inhaler is in Phase 2 development. It is an investigational product and has not been approved by the FDA for any indication. The Phase 2 program has been conducted in children with persistent asthma.
The Phase 2 trial NCT01502371 studied mometasone furoate metered dose inhaler in children with persistent asthma. It was a randomized, double-blind, placebo-controlled study that enrolled 583 participants aged 5 years and older. The trial is listed as completed.
The Phase 2 asthma trial of mometasone furoate metered dose inhaler, NCT01502371, enrolled 583 participants. It was a randomized, double-blind, placebo-controlled study in children with persistent asthma, and it is listed as completed.