Asmanex (Mometasone Furoate Inhalation) - Summary

ASMANEX SUMMARY

ASMANEX^® TWISTHALER^® 220 mcg
(mometasone furoate inhalation powder)

Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid.

ASMANEX TWISTHALER inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older. The ASMANEX TWISTHALER inhaler is also indicated for asthma patients who require oral corticosteroid therapy, where adding ASMANEX TWISTHALER therapy may reduce or eliminate the need for oral corticosteroids.

ASMANEX TWISTHALER is NOT indicated for the relief of acute bronchospasm.

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NEWS HIGHLIGHTS

Published Studies Related to Asmanex (Mometasone Inhalation)

Once-Daily Evening Dosing of Mometasone Furoate Administered Via a Dry Powder Inhaler Does Not Adversely Affect the Hypothalamic-Pituitary-Adrenal Axis. [2009.09.14]
BACKGROUND: Inhaled corticosteroids can suppress the hypothalamic-pituitary-adrenal (HPA) axis with long-term exposure. This study reports the effects of moderate-dose (400 mug) mometasone furoate administered via dry powder inhaler (MF-DPI) once daily in the evening on the HPA axis in adults with mild to moderate asthma... CONCLUSIONS: Once-evening moderate dosing (400 mug) MF-DPI does not suppress HPA- axis function in adults with mild to moderate asthma.

Effect of the inhaled corticosteroid mometasone on small airway patency in patients with asthma. [2009.05]
The inflammation in asthma involves both the large and the small airways. This study was designed to examine whether mometasone delivered from a dry powder inhaler would improve those parameters thought to reflect patency and obstruction of the small airways (diameter <2 mm)... Mometasone delivered by a dry powder inhaler improved asthma control and pulmonary function in tests reflecting both large and small airways.

Effects of mometasone furoate administered via a dry powder inhaler once daily in the evening on nocturnal lung function and sleep parameters in patients with moderate persistent asthma : a randomized, double-blind, placebo-controlled pilot study. [2009]
BACKGROUND AND OBJECTIVE: Nocturnal symptoms are common in asthma patients and have the potential for considerable clinical effects due to a lack of sleep and persistent daytime symptoms of somnolence and activity impairment. The primary objective of this investigation was to determine the effect of a 14-day course of once-daily evening administration of mometasone furoate 400 mug administered via a dry powder inhaler (MF-DPI 400 mug qd pm) on the overnight decline in pulmonary function observed in patients with nocturnal asthma... CONCLUSION: No significant treatment effect on nocturnal pulmonary function, sleep indices or quality of life was observed with 14-day administration of MF-DPI 400 mug qd pm. These findings are limited by the small sample size and the short treatment period evaluated. Future studies are warranted to study the effects of MF-DPI therapy in patients with nocturnal asthma.

Comparable morning versus evening administration of once-daily mometasone furoate dry powder inhaler. [2008.10]
BACKGROUND: The control of daytime and nighttime symptoms is an important measure of effectiveness of asthma therapy, especially, when administered once-daily. OBJECTIVE: To evaluate the efficacy of evening and morning administrations of mometasone furoate administered via a dry powder inhaler (MF-DPI) 400 microg once-daily (QD) to show equivalence... CONCLUSIONS: This open-label study did not identify differences between morning and evening dosing of MF-DPI 400 microg QD. A better effect of evening dosing compared to morning dosing found in previous double-blind placebo-controlled studies could not be confirmed.

Comparison of mometasone furoate dry powder inhaler and fluticasone propionate dry powder inhaler in patients with moderate to severe persistent asthma requiring high-dose inhaled corticosteroid therapy: findings from a noninferiority trial. [2008.04]
BACKGROUND: Inhaled corticosteroids (ICSs) are one of the suggested first-line therapies for patients with persistent asthma of moderate severity... CONCLUSION: MF-DPI 400 microg BID was therapeutically equivalent to FP-DPI 500 microg BID in patients with moderate-to-severe persistent asthma.

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Clinical Trials Related to Asmanex (Mometasone Inhalation)

Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(COMPLETED) [Terminated]
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) PM compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in FEV1 from Baseline to the end of treatment period (Week 12 or end of the study).

Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers [Completed]
This study will compare the performance of three combination metered dose inhalation devices and the variability of mometasone and formoterol doses delivered to the lungs in a healthy volunteer population

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1) [Active, not recruiting]
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by mean change from Baseline to Week 12 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12 hr]).

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED) [Completed]
This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period. Efficacy will be measured by mean area under curve (AUC) of the change from Baseline to Week 12 in FEV1.

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1) [Active, not recruiting]
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 100 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by mean change from Baseline to Week 12 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12 hr]).

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PATIENT REVIEWS / RATINGS / COMMENTS

Asmanex review by 35 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		asthma
Dosage & duration:		220 mcg (dosage frequency: once a day) for the period of One year+
Other conditions:		None
Other drugs taken:		Albuterol inhaler as needed
		Reported Results
Benefits:		Preventative control of asthma symptoms.
Side effects:		None that I experienced.
Comments:		This is the best medication I've ever used for my asthma. It's used to prevent the onset of asthma symptoms, and I've found it to be extremely effective. I take it once a day, and it virtually eliminates any asthma symptoms/attacks. I would recommend it to anyone who suffers from asthma.

Asmanex review by 35 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Asthma
Dosage & duration:		220 mcg (dosage frequency: once a day) for the period of About a year now; ongoing
Other conditions:		None
Other drugs taken:		Albuterol as needed
		Reported Results
Benefits:		Control of asthma symptoms; preventative treatment.
Side effects:		None.
Comments:		This is the best preventative medication I've ever taken for my asthma. I take it once a day, and it virtually eliminates all of my asthma symptoms. I hardly ever have to use my albuterol inhaler anymore. I would recommend this to anyone who suffers from asthma.