Clinical Studies

ALVESCO® (ciclesonide) Inhalation Aerosol reduced nighttime awakenings1,2 for asthma patients new to ICS therapy.

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ALVESCO® (ciclesonide) Inhalation Aerosol reduced nighttime awakenings by 66% from baseline in patients with mild-to-moderate asthma previously treated with a bronchodilator alone, vs a 48% reduction with placebo.1,2

  • LS mean reduction of 0.37 nighttime awakenings with ALVESCO, baseline = 0.56 vs 0.22 with placebo, baseline = 0.46 (P=0.0036 vs placebo)1,2

Study Design: Randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ALVESCO, including 80 mcg twice daily, administered for 16 weeks in 708 patients ≥12 years of age with mild-to-moderate persistent asthma not currently taking ICS therapy. The primary endpoint was LS mean change from baseline in FEV1 to the average of week 12 and week 16, which was significantly improved vs placebo. Daily albuterol use and total asthma symptom score were key secondary endpoints, and nighttime awakenings was an additional secondary endpoint. (ALVESCO 80 mcg bid, n=170; placebo, n=177).1

Important Safety Information: The development of localized infections of the mouth and pharynx with Candida albicans have occurred infrequently. When such infection develops, it may be necessary to interrupt therapy with ALVESCO. If bronchospasm occurs following dosing with ALVESCO, it should be treated immediately with a fast-acting inhaled bronchodilator.


ALVESCO® (ciclesonide) Inhalation Aerosol maintained pulmonary function in asthma patients switched from other ICSs or low-dose ADVAIR Diskus®3,4

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*Includes QVAR® (beclomethasone dipropionate HFA), Flovent® HFA (fluticasone propionate), Pulmicort Flexhaler®(budesonide), and others.

ADVAIR Diskus® (fluticasone propionate and salmeterol inhalation powder).

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Study Design: Randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ALVESCO in 456 patients ≥12 years of age with mild-to-moderate persistent asthma treated previously with ICS or ICS/long-acting β-agonist (LABA) combination. Patients stopped taking their ICS or ICS/LABA combination therapy and were randomized (1:1:1) to treatment with placebo or ALVESCO 160 mcg once (AM) or ALVESCO® (ciclesonide) Inhalation Aerosol 80 mcg twice daily (AM and PM) for 12 weeks.3,4 Once daily is not the approved dosing regimen in the U.S. 80/160 mcg BID. Note: The approved dosing regimen in the U.S. is 80 mcg or 160 mcg BID.

Important Safety Information: It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients particularly when ALVESCO is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of ALVESCO should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and management of asthma.

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References:
1. http://www.clinicaltrials.gov; NCT00174720. Data on file, Study EFC6164 (3031). Sunovion Pharmaceuticals Inc., Marlborough, MA.
2. Berger WE, Kerwin E, Bernstein DI, Pedinoff A, Bensch G, Karafilidis J. Efficacy and safety evaluation of ciclesonide in subjects with mild-to-moderate asthma not currently using inhaled corticosteroids. Allergy Asthma Proc. 2009;30(3):304-314.
3. http://www.clinicaltrials.gov; NCT00174733. Data on file, Study EFC6163 (3030). Sunovion Pharmaceuticals Inc., Marlborough, MA.
4. Meltzer EO, Korenblat PE, Weinstein SF, Noonan M, Karafilidis J. Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids. Allergy Asthma Proc. 2009;30(3):293-303.

Important Safety Information & Indication

ALVESCO is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue, and pharynx, have been reported.

The development of localized infections of the mouth and pharynx with Candida albicans have occurred infrequently. When such an infection develops, it may be necessary to interrupt therapy with ALVESCO. Most cases of candida infection were mild to moderate.

ALVESCO is NOT indicated for the relief of acute bronchospasm.

Patients who are using immunosuppressant doses of corticosteroids are more susceptible to infections than healthy individuals. Chicken pox and measles can have a more serious or even fatal course in susceptible individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections.

Particular care is needed for patients who are transferred from systemically active corticosteroids due to the potential for adrenal insufficiency. Patients should taper slowly from systemic corticosteroids if switching to ALVESCO.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients particularly when ALVESCO is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of ALVESCO should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and management of asthma.

Decreases in bone mineral density have been observed with long-term administration of inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care.

Orally inhaled corticosteroids may cause reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ALVESCO. To minimize the systemic effects, patients should be titrated to the lowest dosage that effectively controls symptoms.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of inhaled corticosteroids including ALVESCO. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

If bronchospasm occurs following dosing with ALVESCO, it should be treated immediately with a fast-acting inhaled bronchodilator.

The most common adverse reactions occurring at an incidence greater than or equal to 3% in any of the ALVESCO groups and which were more frequent with ALVESCO compared with placebo were headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in extremity, and back pain.

Full Prescribing Information for ALVESCO

Indication
ALVESCO® (ciclesonide) Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.