Asmanex (Mometasone Furoate Inhalation) - Summary

ASMANEX SUMMARY

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

Treatment of Asthma

ASMANEX^® TWISTHALER^® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.

Important Limitations of Use

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

ASMANEX TWISTHALER is NOT indicated in children less than 4 years of age.

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NEWS HIGHLIGHTS

Published Studies Related to Asmanex (Mometasone Inhalation)

The efficacy and tolerability of inhaled montelukast plus inhaled mometasone compared with mometasone alone in patients with chronic asthma. [2011.06]
BACKGROUND: The efficacy of oral montelukast in chronic asthma is well established. Montelukast is also an effective adjunctive therapy to inhaled corticosteroids (ICS) in asthma uncontrolled on ICS alone. Inhaled montelukast was recently shown to provide significant bronchodilation compared with placebo in patients with chronic asthma. The purpose of this study was to evaluate the efficacy of inhaled montelukast added to inhaled mometasone... CONCLUSION: Inhaled montelukast plus inhaled mometasone was significantly more effective than placebo plus inhaled mometasone in improving FEV(1), symptoms, asthma control, and blood eosinophil count.

Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. [2010.12]
OBJECTIVE: The combination of inhaled corticosteroid (ICS) and long-acting beta-agonist is recommended for treatment of patients with persistent asthma inadequately controlled on ICS monotherapy. This study was conducted to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) administered through metered-dose inhaler (MDI) in patients with persistent asthma previously on medium- to high-dose ICS... CONCLUSIONS: One-year treatment with the new combination therapies - twice-daily MF/F-MDI 200/10 and 400/10 mug - is safe and well tolerated in patients with persistent asthma.

Efficacy and safety of two dry-powder inhalers for the administration of mometasone furoate in asthma patients. [2010.07]
OBJECTIVE: Mometasone furoate (MF) is a new, potent synthetic inhaled corticosteroid. Worldwide, MF is administered via a dry-powder inhaler that contains multiple doses. As a preparation that would be more cost-effective, single-dose MF capsules were developed in Brazil. The objective of the present study was to evaluate the efficacy and safety of the two inhalers for MF administration in patients with asthma... CONCLUSIONS: The use of the single-dose inhaler developed in Brazil for MF administration is as effective and safe as is that of a standard inhaler in the treatment of patients with asthma.

Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomized open-label study. [2010.01.05]
BACKGROUND: Poor adherence with prescribed asthma medication is a major barrier to positive treatment outcomes. This study was designed to determine the effect of a once-daily administration of mometasone furoate administered via a dry powder inhaler (MF-DPI) on treatment adherence compared with a twice-daily administration... CONCLUSION: Mean adherence rates were greater with a once-daily dosing regimen of MF-DPI than with a twice-daily dosing regimen.This trial was completed prior to the ISMJE requirements for trial registration.

Effect of therapeutic doses of mometasone furoate on cortisol levels in children with mild asthma. [2010.01]
Corticosteroids are the foundation of pharmacologic treatment for children with asthma. However, high-dose inhaled corticosteroid treatment can cause hypothalamic-pituitary-adrenal (HPA) axis suppression...

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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)(TERMINATED) [Terminated]
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED) [Completed]
This is a multicenter, randomized, double-blind within the dose level, parallel group comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to examine the minimal effective dose, the recommended dose, and the dosing regimen.

Acute Effect of Mometasone on Beta-adrenergic Airway and Airway Vascular Relaxation in Severe Asthma [Completed]
Glucocorticosteroids inhibit the disposal of organic cations by blocking organic cation transporters expressed by non-neuronal cells, thereby interfering with the inactivation of the organic cations by intracellular enzymes. Beta2-adrenergic agonists are organic cations, and the concentration of inhaled beta2-adrenergic agonists at beta2-adrenergic receptor sites on smooth muscle is likely to be increased by inhaled glucocorticosteroids (ICS) by the ICS' effect on the glucocorticosteroid-sensitive organic cation transporters. The investigators have shown in human airway vascular smooth muscle cells that the glucocorticosteroid action on organic cation uptake occurs within minutes, does not involve gene transcription or protein synthesis, is not mediated through classical steroid receptors, and is cell membrane-linked. In the present proposal, the investigators wish to use different single doses of mometasone, a clinically effective ICS, administered with or at different times before albuterol inhalation in subjects with moderate persistent asthma who are obstructed at the time of study. With this approach the investigators will test the hypothesis that a single inhalation of mometasone causes an acute, transient, dose-dependent potentiation of beta2-adrenergic bronchodilation. If the hypothesis that a single dose of mometasone acutely potentiates beta2-adrenergic bronchodilation is correct, the results would have a significant impact on treatment strategies involving ICSs and beta2-adrenergic agonists in patients with asthma.

Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy [Withdrawn]
Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep characterized by prolonged partial upper airway obstruction and/or intermittent complete obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition occurs in 2-5% of children and can occur at any age, but it is most common in children between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease, growth delay, poor learning and behavioral problems such as inattention and hyperactivity. The most common underlying risk factor for the development of OSA is enlargement of tonsils and adenoids. Given the potential risk of complications associated with surgery of the tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to moderate OSA4. The authors recommended that further randomised controlled studies were required to evaluate the efficacy of INCSs in children with OSA. In particular they recommended that future studies should employ sleep studies to look for any improvement with INCSs, and should include children with more severe OSA, as these are the patients at the greatest risk of complications of surgery and would benefit most from a non-surgical treatment. The purpose of this study is therefore to explore the efficacy of INCSs in children with the full spectrum of OSA severity, including sleep study analysis., and longer term follow-up.

A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512) [Completed]
This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.

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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 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Asthma
Dosage & duration:		once a day (dosage frequency: once a day) for the period of 6 months
Other conditions:		none
Other drugs taken:		albuterol when need it
		Reported Results
Benefits:		It works great, no asthma symptoms.
Side effects:		But I'm loosing a lot of hair, there's mild pain in my lungs and legs on a regular basis and mouth infections.
Comments:		I'm was diagnosed with asthma around six months ago after getting pneumonia that lasted 3 months. I did have allergies before but never any asthma symptoms.

Asmanex review by 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Asthma
Dosage & duration:		once a day (dosage frequency: once a day) for the period of 6 months
Other conditions:		none
Other drugs taken:		albuterol when need it
		Reported Results
Benefits:		It works great, no asthma symptoms.
Side effects:		But I'm loosing a lot of hair, there's mild pain in my lungs and legs on a regular basis and mouth infections.
Comments:		I'm was diagnosed with asthma around six months ago after getting pneumonia that lasted 3 months. I did have allergies before but never any asthma symptoms.