Our comprehensive guide hospitals information helps you quickly locate a hospital anywhere in the world. Our database contains in excess of 16,000 hospitals, making it one of the best places to find information on the hospital you are searching for. To assist you with locating a hospital, you can refine your search by selecting the country in which the hospital is located and choose to search by either hospital name, city/town or state/county.

 Home>> Alvesco (ciclesonide)

Alvesco (ciclesonide)

General Information

Alvesco is a non-halogenated glucocorticoid prodrug delivered via a metered dose inhaler.

Alvesco is specifically indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

Alvesco is supplied as a 80 mcg or 160 mcg dose designed for oral inhalation. The recommended initial dose of the drug is as follows:

Patients over 12 years who previously received bronchodilators alone:
Recommended starting dose: 80 mcg twice daily.
Highest recommended dose: 160 mcg twice daily.

Patients over 12 years who previously received inhaled corticosteroids:
Recommended starting dose: 80 mcg twice daily.
Highest recommended dose: 320 mcg twice daily.

Patients over 12 years who received oral corticosteroids:
Recommended starting dose: 320 mcg twice daily.
Highest recommended dose: 320 mcg twice daily.


Additional Information

For additional information regarding Alvesco or asthma, please visit the Alvesco web page.


Clinical Results

FDA Approval
FDA approval of Alvesco was based on the results of six randomized double-blind, placebo controlled, parallel-group clinical trials in adult and adolescent subjects 12 years of age and older with mild persistent to severe persistent asthma. The primary efficacy endpoint in four of the six trials was the mean change from baseline in pre-dose FEV1 at endpoint (last observation). FEV1 was measured prior to the morning dose of study medication (at the end of the 24-hour dosing interval for once daily administration, and at the end of the 12-hour dosing interval for twice daily administration). In one of the six trials, the primary endpoint was the change from baseline in the average of the pre-dose FEV1 at Weeks 12 and 16, and in another trial, reduction of oral corticosteroid use was the primary efficacy endpoint. The results are as follows:

Patients Previously Maintained on Bronchodilators Alone
This randomized, double-blind, placebo controlled trial enrolled 691 subjects with a mean baseline percent predicted FEV1 of 72%. The subjects Alvesco 160 mcg once daily in the morning for 16 weeks, Alvesco 80 mcg twice daily for 16 weeks, or Alvesco 80 mcg twice daily for 4 weeks followed by Alvesco 160 mcg once daily in the morning for 12 weeks or placebo for 16 weeks. All Alvesco doses showed statistically significant improvement over placebo at week 16 in AM pre-dose FEV1. However, the increase in the Alvesco 80 mcg twice daily arm was significantly greater than that observed in the Alvesco 160 mcg administered once daily arm. Compared to placebo, increases in AM pre-dose FEV1 were 0.12 L or 5.0 % for Alvesco 160 mcg once daily, 0.24 L or 10.4 % for Alvesco 80 mcg twice daily, 0.13 L or 5.0 % for Alvesco 80 mcg twice daily for 4 weeks followed by Alvesco 160 mcg once daily. Other measures of asthma control, AM PEF and need for rescue albuterol also improved in all the Alvesco treatment groups compared to placebo but the improvement was greatest with the Alvesco 80 mcg twice daily treatment arm.

Patients Previously Maintained on Inhaled Corticosteroids
Nycomed conducted two randomized-double blind placebo controlled trials each of 12-weeks treatment duration. In the first trial subjects with mean baseline percent predicted FEV1 of 79% received Alvesco 160 mcg once daily in the morning, ALVESCO 80 mcg twice daily or placebo. Statistically significantly more increases in AM pre-dose FEV1 compared to placebo were seen at 12 weeks for Alvesco 160 mcg once daily (0.14 L or 5.7%) and Alvesco 80 mcg twice daily (0.19 L or 7.5%). Asthma symptoms scores, AM PEF, and decreased need for rescue albuterol remained relatively stable in the Alvesco treatment groups compared to slight worsening in the placebo group.

In the second trial, 257 subjects with mean baseline percent predicted FEV1 of 54% were treated with Alvesco 160 or 320 mcg twice daily for 12 weeks. Compared to placebo, both Alvesco doses showed statistically significantly more improvement in pre-dose FEV1 (0.11 L or 8.6% and 0.18 L or 11.8%). Other measures of asthma control, AM PEF, symptoms, and need for rescue albuterol also showed improvement compared to placebo.

Patients Previously Maintained on Oral Corticosteroids:
This 12-week, double-blind clinical trial enrolled 140 subjects with mean FEV1 at baseline 53% predicted. The subjects were randomized to Alvesco given by inhalation aerosol at doses of 320 or 640 mcg twice daily or placebo. The average corticosteroid (prednisone) dose at baseline was approximately 12 mg/day. Compared to patients on placebo whose prednisone requirements increased by 4%, those treated with Alvesco 320 mcg and 640 mcg twice daily significantly reduced their prednisone requirements by 47% and 62% respectively. Those on Alvesco also maintained asthma control as reflected by lung function, symptoms, and need for rescue albuterol. A significantly larger percentage of patients on Alvesco were able to reduce oral prednisone use by 50% or more as compared to placebo (64% and 77% of the patients treated with 320 mcg and 640 mcg respectively twice daily as compared with 33% of patients on placebo).


Mechanism of Action

Alvesco is a non-halogenated glucocorticoid prodrug delivered via a metered dose inhaler. It is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following oral inhalation. Des-ciclesonide has anti-inflammatory activity with affinity for glucocorticoid receptors that is 120 times greater than the parent compound and 12 times greater than dexamethasone.


Literature References

Side effects

Adverse events associated with the use of Alvesco may include, but are not limited to, the following:

  • Headache
  • Nasopharyngitis
  • Upper respiratory Infection
  • Sinusitis
  • Pharyngolaryngeal pain
  • Nasal congestion
  • Back pain
  • Arthralgia
  • Pain in extremity

Treatment

asthma

Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Accretropin (somatropin rDNA Original) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Carnexiv (carbamazepine) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Rythmol Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Plavix (clopidogrel bisulfate) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Nuplazid (pimavanserin) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Infasurf Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Makena (hydroxyprogesterone caproate injection) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Pramipexole Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Cyramza (ramucirumab) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Actiq Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Tilade (nedocromil sodium) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Alvesco (ciclesonide) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print laViv (azficel-T) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Galzin (zinc acetate) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Restasis (cyclosporine ophthalmic emulsion) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Praxbind (idarucizumab) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Lovenox (enoxaparin sodium) Injection Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Ravicti (glycerol phenylbutyrate) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Zithromax (azithromycin) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Belviq (lorcaserin hydrochloride) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Arthrotec Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Rayos (prednisone) delayed-release tablets Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Prinivil or Zestril (Lisinopril) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Estratab (.3 mg ) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print ReoPro Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Pepcid Complete Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Betapace AF Tablet Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print RenaGelRenagel (sevelamer hydrochloride) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print BeneFIX (coagulation Factor IX (recombinant)) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Brintellix (vortioxetine) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Omontys (peginesatide) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Bydureon (exenatide extended-release for injectable suspension) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Picato (ingenol mebutate) gel Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Keppra Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Anzemet Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Periostat (doxycycline hyclate) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Abilify (aripiprazole) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Propecia Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Proventil HFA Inhalation Aerosol Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Xifaxan (rifaximin)