Beclomethasone dipropionate is used by oral inhalation for the long-term prevention of bronchospasm in patients with asthma.
Beclomethasone dipropionate oral inhalation therapy should not be used in the treatment of nonasthmatic bronchitis. Oral inhalation of beclomethasone dipropionate is contraindicated in the primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required. Beclomethasone dipropionate oral inhaler is not a bronchodilator, and patients should be warned that the drug should not be used for rapid relief of bronchospasm. Beclomethasone dipropionate oral inhalation therapy is not effective for all patients with bronchial asthma (e.g., in patients with bronchorrhea or severe pulmonary obstruction when proper penetration of the drug into the lungs is prevented). In addition, the drug is not always effective at all stages of the disease in a particular patient.
Mild Persistent Asthma
Drugs for asthma may be categorized as relievers (e.g., bronchodilators taken as needed for acute symptoms) or controllers (principally inhaled corticosteroids or other anti-inflammatory agents taken regularly to achieve long-term control of asthma). In the stepped-care approach to antiasthmatic drug therapy, current asthma management guidelines and most clinicians recommend initiation of a controller drug such as an anti-inflammatory agent, preferably a low-dose orally inhaled corticosteroid (e.g., 88-264, 88-176, or 176 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler in adolescents and adults, children 5-11 years of age, or children 4 years of age or younger, respectively) as first-line therapy for persistent asthma (i.e., patients with daytime symptoms of asthma more than twice weekly, but less than once daily, and nocturnal symptoms of asthma 3-4 times per month), supplemented by as-needed use of a short-acting, inhaled β2-agonist. For equivalent orally inhaled dosages of corticosteroids,
Moderate Persistent Asthma
According to current asthma management guidelines, therapy with a long-acting inhaled β2-agonist such as salmeterol or formoterol generally is recommended in adults and adolescents who have moderate persistent asthma and daily asthmatic symptoms that are inadequately controlled following addition of low-dose inhaled corticosteroids to as-needed inhaled β2-agonist treatment. However, the National Asthma Education and Prevention Program (NAEPP) recommends that the beneficial effects of long-acting inhaled β2-agonists should be weighed carefully against the increased risk (although uncommon) of severe asthma exacerbations and asthma-related deaths associated with daily use of such agents. Current asthma management guidelines also state that an alternative, but equally preferred option for management of moderate persistent asthma that is not adequately controlled with a low dosage of inhaled corticosteroid is to increase the maintenance dosage to a medium dosage (e.g., exceeding 264 but not more than 440 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler in adults and adolescents).
In children 5-11 years of age with moderate persistent asthma that is not controlled with a low dosage of an inhaled corticosteroid, a long-acting inhaled β2-agonist (e.g., salmeterol, formoterol), a leukotriene modifier (i.e., montelukast, zafirlukast), or extended-release theophylline (with appropriate monitoring) may be added to low-dose inhaled corticosteroid therapy according to current asthma management guidelines; another preferred option is to increase the maintenance dosage of the inhaled corticosteroid to a medium dosage (e.g., exceeding 176 but not more than 352 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler). In infants and children 4 years of age or younger with moderate persistent asthma that is not controlled by a low dosage of an inhaled corticosteroid, the only preferred option is to increase the maintenance dosage of the inhaled corticosteroid to a medium dosage (e.g., exceeding 176 but not more than 352 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler).
Severe Persistent Asthma
Maintenance therapy with an inhaled corticosteroid at medium or high dosages (e.g., exceeding 440 mcg of fluticasone propionate in adults and adolescents or 352 mcg of the drug in children 5-11 years of age [or its equivalent] daily via a metered-dose inhaler) and adjunctive therapy with a long-acting inhaled β2-agonist is the preferred treatment according to current asthma management guidelines for patients 5 years of age or older with severe persistent asthma (i.e., continuous daytime asthma symptoms, nighttime symptoms 7 times per week). In infants and children 4 years of age or younger with severe asthma, maintenance therapy with an inhaled corticosteroid at medium or high dosages (e.g., exceeding 352 mcg of fluticasone propionate [or its equivalent] daily via a metered-dose inhaler) and adjunctive therapy with either a long-acting inhaled β2-agonist or montelukast is recommended in current asthma management guidelines as the only preferred treatment.
Poorly Controlled Asthma
If asthma symptoms in patients with moderate to severe asthma are very poorly controlled (i.e., at least 2-3 exacerbations per year requiring oral corticosteroids), a short course (3-10 days) of an oral corticosteroid may be added to gain prompt control of asthma. Regular use of oral corticosteroids as add-on therapy in adults and children 5 years of age or older with severe asthma who are inadequately controlled with high-dose inhaled corticosteroid, intermittent oral corticosteroid therapy, and a long-acting inhaled β2-agonist bronchodilator is suggested, based on consensus and clinical experience. A short course (2 weeks) of oral corticosteroids may be considered to confirm clinical response prior to implementing long-term therapy with these agents. Once long-term oral corticosteroid therapy is initiated, the lowest possible effective dosage (i.e., alternate-day or once-daily administration) should be used, and the patient should be monitored carefully for adverse effects. Once asthma is well controlled, repeated attempts should be made to reduce the oral corticosteroid dosage. Use of orally inhaled beclomethasone dipropionate as adjunctive therapy in patients who require chronic administration of systemic corticosteroids to control asthma symptoms may permit a reduction in dosage or discontinuance of systemic corticosteroids. For additional details on the stepped-care approach to drug therapy in asthma, and
Clinical Experience with Beclomethasone Dipropionate
Well-controlled clinical studies have shown that oral inhalation of beclomethasone dipropionate relieves symptoms of bronchial asthma (cough, dyspnea, wheezing) and improves lung function (e.g., forced expiratory volume in 1 second [FEV1]) in most adults and children. Although some improvement may occur shortly after therapy is initiated, optimum symptomatic relief may require 1-4 weeks of continuous beclomethasone dipropionate oral inhalation therapy in patients who have not previously received systemic corticosteroid therapy. In corticosteroid-dependent asthmatic patients being switched to beclomethasone dipropionate oral inhalation therapy, withdrawal of systemic corticosteroid therapy and management of asthma with orally inhaled beclomethasone dipropionate may be delayed, since recovery from hypothalamic-pituitary-adrenal (HPA) axis suppression occurs slowly. Clinical studies have shown that therapy with orally inhaled beclomethasone dipropionate may allow eventual dosage reduction or total replacement of systemic corticosteroid therapy.
When beclomethasone dipropionate is administered by oral inhalation, the principal sites of action are the bronchi and bronchioles. Limited data suggest that substantially more drug is deposited into the airways of the lung and less reaches the oropharynx with beclomethasone dipropionate inhalation aerosols containing tetrafluoroethane (HFA-134a, a non-chlorofluorocarbon [CFC] propellant) (QVAR) than with inhalation aerosols containing CFC propellant (e.g., Beclovent, Vanceril, Vanceril Double Strength; all no longer commercially available in the US). In clinical studies of 6 weeks' to 12 months' duration, treatment with beclomethasone dipropionate with non-CFC propellant, administered at approximately half the daily dosage of beclomethasone dipropionate with CFC propellant, was associated with similar efficacy (i.e., control of moderate or moderately severe asthma) and safety; however, a definitive comparative therapeutic ratio has not been demonstrated to date. Unlike dexamethasone sodium phosphate, beclomethasone dipropionate appears to have higher topical anti-inflammatory activity with fewer adverse systemic effects following oral inhalation; however, no direct comparison of the adverse effects of these drugs has been performed.
In corticosteroid-dependent patients, use of beclomethasone dipropionate oral inhalation therapy usually permits a substantial reduction in the daily maintenance dosage of the systemic corticosteroid, conversion from daily to alternate-day corticosteroid therapy, or gradual discontinuance of corticosteroid maintenance dosages.
(See Cautions: Hypothalamic-Pituitary-Adrenal Axis Suppression.)
In the management of asthma, the need for single- vs multiple-drug therapy must be determined on an individual basis. Beclomethasone dipropionate oral inhalation therapy has been administered to patients receiving bronchodilator and/or cromolyn sodium therapy. In a well-controlled study in corticosteroid-dependent asthmatic patients receiving either orally inhaled beclomethasone dipropionate or alternate-day prednisone, the addition of theophylline to either regimen at dosages that maintained therapeutic serum theophylline concentrations resulted in greater symptomatic relief and improved pulmonary function compared with therapy that did not include theophylline. In several controlled studies in asthmatic patients, concurrent therapy with orally inhaled beclomethasone dipropionate and cromolyn sodium did not provide a clinical advantage over beclomethasone dipropionate therapy alone; however, in an uncontrolled study, symptomatic relief of bronchial asthma was greater during concurrent therapy with orally inhaled beclomethasone dipropionate and cromolyn sodium than with either drug alone.
The efficacy of orally inhaled beclomethasone dipropionate in the management of patients with chronic obstructive pulmonary disease (e.g., bronchitis) who are stabilized with oral corticosteroids or whose disease is corticosteroid responsive remains to be fully evaluated. Limited data suggest that orally inhaled beclomethasone dipropionate may be useful in some patients with chronic obstructive pulmonary disease, but is probably not an adequate substitute for oral corticosteroid therapy in patients with steroid-responsive disease. Whether orally inhaled beclomethasone can maintain improvement in pulmonary function initially produced by oral corticosteroid therapy has not been established.
Beclomethasone dipropionate has been used as an oral solution or rectal suspension in the management of inflammatory diseases of the GI tract. In a group of patients with inflammatory bowel disease, treatment with enemas containing beclomethasone dipropionate resulted in symptomatic improvement without producing adverse systemic effects. In a patient with eosinophilic gastroenteritis, administration of an oral solution of beclomethasone dipropionate improved intestinal absorptive function. The role of beclomethasone dipropionate in the management of inflammatory conditions of the GI tract remains to be established.
For other uses of beclomethasone dipropionate,