Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mometasone furoate/formoterol · 3 trials · 1 indication
Mometasone furoate plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of mometasone furoate was determined with Phoenix WinNonlin (Version 8.0 or higher). A correction factor was applied to MF pharmacokinetic parameters to consider the first-dose effect that is based on the fact that the participants in this study received a single dose from single unused (unprimed) C1 and TH devices. Unprimed devices are not coated with the formulation, and therefore may lead to lower fine particle mass (FPM) and delivered dose compared to later doses actuated from the device throughout its use time. The first-dose correction factor (FPMprimed (MF) / FPMunprimed (MF)) for MF delivered via TH was 1.26 and for MF delivered via C1 it was 1.62.
AUC0-6h of mometasone furoate was determined using non-compartment methods with Phoenix WinNonlin (Version 8.0 or higher). The linear trapezoidal rule was used for AUC0-6h calculation. A correction factor was applied to MF pharmacokinetic parameters to consider the first-dose effect that is based on the fact that the participants in this study received a single dose from single unused (unprimed) C1 and TH devices. Unprimed devices are not coated with the formulation, and therefore may lead to lower fine particle mass (FPM) and delivered dose compared to later doses actuated from the device throughout its use time. The first-dose correction factor (FPMprimed (MF) / FPMunprimed (MF)) for MF delivered via TH was 1.26 and for MF delivered via C1 it was 1.62.
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.
For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was in L, being a weighted average of the acceptable FEV1 measurements recorded over 12 hours post dose
| Arm | Type | Description |
|---|---|---|
| MF followed by QMF149 | EXPERIMENTAL | Single inhaled dose of mometasone furoate on Day 1 delivered via TH inhaler followed by 4-7 days of washout. On Day 6-9, single inhaled dose of QMF149 delivered via C1 inhaler. |
| Mometasone furoate 80 μg | EXPERIMENTAL | Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks. |
| Mometasone furoate 200 µg | EXPERIMENTAL | Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks. |
| Mometasone furoate 320 µg | EXPERIMENTAL | Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks. |
| Mometasone furoate 800 µg | EXPERIMENTAL | Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks. |
| F12M - PL - F12D - MFF | EXPERIMENTAL | Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication. |
| F12D - F12M - MFF - PL | EXPERIMENTAL | Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication. |
| MFF - F12D - PL - F12M | EXPERIMENTAL | Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication. |
| PL - MFF - F12M - F12D | EXPERIMENTAL | Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication. |
| Name | Type | Description |
|---|---|---|
| Mometasone furoate | DRUG | Single inhaled dose of 100 µg mometasone furoate (MF) administered via Twisthaler® on Day 1 |
| QMF149 | DRUG | Single inhaled dose of QMF149 (75/40 µg indacaterol acetate/MF fixed dose combination) administered via Concept 1 device on Day 6-9 |
| Standard of Care (Soc) | DRUG | Asthma therapy: budesonide and salbutamol being the most frequently used (excluding MF and indacaterol acetate) |
| Concept 1 | DEVICE | A single dose dry powder inhaler (SDDPI) |
| Twisthaler | DEVICE | A single dose dry powder inhaler (SDDPI) |
| Mometasone furoate/formoterol fumarate (MFF) | DRUG | Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg. |
| Formoterol fumarate 12 μg pMDI (F12M) | DRUG | Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg). |
| Formoterol fumarate 12 μg DPI (F12D) | DRUG | Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI). |
| Placebo to F12D | DRUG | Placebo to formoterol fumarate DPI delivered via DPI |
| Placebo to F12M/MFF | DRUG | Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI |
Inclusion Criteria: 1. Male and female children ≥ 6 years and \< 12 years at the time of study entry. 2. Written informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific...
Mometasone furoate is an investigational small molecule being studied for use in asthma and in healthy volunteers. It is being developed by Novartis AG (NVS). Clinical trials have evaluated it in patients with persistent asthma, including children, adolescents, and adults, as well as in healthy adult volunteers.
Mometasone furoate is a corticosteroid that works by reducing inflammation in the airways. It is being studied in combination with other inhaled medications, such as formoterol fumarate and indacaterol, for the treatment of asthma. The drug is delivered via inhalation devices.
Mometasone furoate is being developed by Novartis AG, a global healthcare company traded under the ticker NVS. Novartis has sponsored multiple clinical trials investigating the drug for asthma and in healthy volunteers.
Mometasone furoate is in clinical development, with trials listed as Phase 1 and Phase 2. It is not approved and remains investigational. Three trials have been completed, and no active trials are currently listed.
Mometasone furoate has been studied in three completed trials: NCT00418509 in healthy volunteers, NCT00746330 in children with persistent asthma, NCT01555151 in adults and adolescents with asthma, and NCT04589663 in children with asthma. These trials evaluated safety, efficacy, and pharmacokinetics.
No, Mometasone furoate is a separate drug, a corticosteroid. It has been studied in combination with formoterol fumarate and with indacaterol, which are bronchodilators. The trials listed evaluate the combination products, not Mometasone furoate alone.