The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H₁-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate (Nasonex 24 HR Allergy, and generics), for treatment of seasonal allergic rhinitis symptoms in persons ≥12 years old. Ryaltris is the second intranasal antihistamine/corticosteroid combination to be approved for this indication; azelastine 0.1%/fluticasone propionate (Dymista, and generics), which is approved for use in persons ≥6 years old, was the first. Both products are available only by prescription.

The choice of drugs for treatment of allergic rhinitis depends on the severity of symptoms and whether they are intermittent or persistent (see Table 1).

View the Comparison Table: Some Oral Drugs for Allergic Rhinitis

View the Comparison Table: Some Nasal Sprays for Allergic Rhinitis

The goal of asthma treatment is to control symptoms, prevent exacerbations, and maintain normal lung function. Management of acute exacerbations of asthma in the emergency department is not discussed here.

View the table: Some Inhaled Drugs for Treatment of Asthma

The main goals of treatment for chronic obstructive pulmonary disease (COPD) are to relieve symptoms, reduce the frequency and severity of exacerbations, and prevent disease progression. Several guidelines and review articles on COPD treatment have been published in recent years. Treatment of acute exacerbations is not discussed here.

View the Comparison Table: Inhaled Long-Acting Bronchodilators for Treatment of COPD

View the Comparison Table: Inhaled Corticosteroids for Treatment of COPD

View the Table: Correct Use of Inhalers for COPD

Atopic dermatitis (AD; also known as eczema) is frequently associated with other atopic disorders such as allergic rhinitis, asthma, and food allergy. It commonly presents in infancy and early childhood and has a relapsing course, often improving by adolescence, but sometimes persisting into (or first appearing in) adulthood or even old age.

Patients with seasonal allergies often experience nasal itching and congestion, sneezing, rhinorrhea, and itchy, watery eyes. Oral, intranasal, and ophthalmic preparations are widely available over the counter (OTC) for relief of symptoms. Prescription products for management of allergic rhinitis and allergic conjunctivitis are reviewed separately.

The FDA has approved Trelegy Ellipta (GSK), a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, the long-acting antimuscarinic agent (LAMA) umeclidinium, and the long-acting beta₂-agonist (LABA) vilanterol. It is available as a dry powder inhaler for once-daily maintenance treatment of COPD and to reduce COPD exacerbations in patients with a history of exacerbations. Trelegy Ellipta is the first three-drug inhaler for treatment of COPD to become available in the US.

The goal of asthma treatment is to control symptoms and prevent exacerbations. Management of acute exacerbations of asthma is not discussed here.

View the Comparison Table: Some Inhaled Drugs for Treatment of Asthma

View the Comparison Table: Correct Use of Inhalers

View the Comparison Table: Some Topical Corticosteroids

The nasal spray formulation of the corticosteroid fluticasone furoate is now available over the counter (OTC) as Flonase Sensimist Allergy Relief (GSK) in the same strength as the prescription product (Veramyst) for treatment of seasonal or perennial allergic rhinitis. It is the fourth intranasal corticosteroid to become available OTC.

The main goals of treatment for chronic obstructive pulmonary disease (COPD) are to relieve symptoms, reduce the frequency and severity of exacerbations, and prevent disease progression. Updated guidelines for treatment of COPD have been published in recent years.

View the Comparison Table: Inhaled Long-Acting Bronchodilators for COPD

View the Comparison Table: Some Inhaled Corticosteroids for COPD

View the Table: Correct Use of Inhalers for COPD

The FDA has approved Arnuity Ellipta (GSK), a single-agent inhaler containing the corticosteroid fluticasone furoate, for once-daily maintenance treatment of asthma in patients ≥12 years old. Fluticasone furoate is also available in combination with the long-acting beta₂-agonist vilanterol as Breo Ellipta for treatment of asthma and COPD.

The nasal spray formulation of the corticosteroid fluticasone propionate is now available over the counter (OTC) as Flonase Allergy Relief (GSK) in the same strength as the prescription product (Flonase, and generics) for patients ≥4 years old with seasonal or perennial allergic rhinitis. It is the second corticosteroid nasal spray to become available OTC; triamcinolone acetonide (Nasacort Allergy 24HR) was the first. Unlike prescription Flonase, the OTC product is FDA-approved for reduction of ocular as well as nasal symptoms. Brand-name prescription Flonase has been discontinued by the manufacturer.

Olodaterol (Striverdi Respimat – Boehringer Ingelheim), a new inhaled long-acting beta₂-agonist, has been approved by the FDA for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Olodaterol is the third long-acting beta₂-agonist to be approved by the FDA for once-daily use; indacaterol (Arcapta Neohaler), which is available as a single agent, and vilanterol, which is available only in fixed-dose combinations with the long-acting anticholinergic umeclidinium (Anoro Ellipta) or the corticosteroid fluticasone furoate (Breo Ellipta), were approved earlier.

The use of drugs to prevent and control symptoms of allergic disorders can be optimized when patients avoid exposure to specific allergens and/or environmental conditions that trigger or worsen their symptoms.

The FDA has approved a nasal spray fixed-dose combination (Dymista – Meda) of the H₁-antihistamine azelastine (Astelin, Astepro, and generics) and the corticosteroid fluticasone propionate (Flonase, and generics) for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old who need both medications for symptomatic relief. It is the first nasal spray to be approved in the US that contains both an H₁-antihistamine and a corticosteroid.

A little more than a year ago, The Medical Letter reported the results of an FDA meta-analysis which found that use of a long-acting beta-2 agonist (LABA) such as salmeterol (Severent) or formoterol (Foradil) in patients with asthma was associated with an increased risk of a composite endpoint of asthma-related death, intubation or hospitalization; the highest risk was in children 4-11 years old.There was no significant increase in risk when a long-acting beta-2 agonist was used with an inhaled corticosteroid.The Medical Letter recommended that long-acting beta-2 agonists should not be used as monotherapy for asthma, especially in children, and that long-acting beta-2 agonists should be used for asthma only in combination with an inhaled corticosteroid, preferably in a fixed-dose combination in the same inhaler.1

Now the FDA has issued new Safe Use Requirements2 and labeling requirements for long-acting beta-2 agonists that include the following: “Stop use of the LABA, if possible, once asthma control is achieved and maintain the use of an asthma-controller medication such as an inhaled corticosteroid.”3

It has not been determined that patients taking a longacting beta-2 agonist in a fixed-dose combination with an inhaled corticosteroid have an increased risk of death or that stopping long-acting beta-2 agonists in such patients will improve long-term outcomes. A controlled clinical trial of these new requirements would be welcome.

1. Long-acting beta-2 agonists in asthma. Med Lett Drugs Ther 2009; 51:1.
2. www.fda.gov/safety/medwatch/default.htm
3. BA Chowdhury and G Dal Pan. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med 2010; Feb 24 (epub).

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The pathogenesis of acne is multifactorial: follicular hyperkeratinization, bacteria, sebum production, androgens and inflammation all play a role. The gram-positive microaerophilic bacteria Propionibacterium acnes promote development of acne lesions by secreting chemotactic factors that attract leukocytes to the follicle, causing inflammation.

The FDA has approved the marketing of the corticosteroid ciclesonide (Alvesco - Sepracor) in a hydrofluoroalkane (HFA) metered-dose inhaler formulation for maintenance treatment of asthma in patients >12 years old. Ciclesonide is also available in the US as a nasal spray for allergic rhinitis (Omnaris), and has been available for asthma in Europe since 2003.

Ciclesonide (Omnaris - Sepracor/Nycomed), a once daily corticosteroid nasal spray, is now available for treatment of seasonal allergic rhinitis (SAR) in adults and children ≥6 years old and for perennial allergic rhinitis (PAR) in those ≥12 years old. An orally inhaled formulation of ciclesonide (Alvesco) was recently approved by the FDA for maintenance treatment of asthma, and will be reviewed in a future issue of The Medical Letter

A combination of the corticosteroid budesonide and the long-acting beta₂-agonist formoterol (Symbicort - AstraZeneca) has become available in a metered dose inhaler for long-term maintenance treatment of asthma in patients ≥ 12 years old. A combination product that contains fluticasone propionate and salmeterol (Advair) is already available for this indication in the US. Neither one of these combinations is approved for acute treatment of asthma symptoms. A dry powder inhaler formulation of Symbicort has been available in Europe and Canada for several years.

Fluticasone furoate nasal spray (Veramyst - GSK) is now available for once-daily treatment of seasonal and perennial allergic rhinitis in adults and children ≥2 years old. It is similar to fluticasone propionate nasal spray (Flonase, and others), which is now available generically.

Allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria, anaphylaxis and asthma (reviewed in Treatment Guidelines 2005; 3:33 and not included here), are prevalent worldwide, especially in industrialized countries. Pharmacologic treatment of these disorders continues to improve in efficacy and safety. In addition to using drugs to prevent and control the symptoms of their allergic diseases, patients should also be instructed to avoid, if possible, specific allergens and/or environmental conditions that trigger or worsen their symptoms.

The FDA has approved marketing of the corticosteroid mometasone furoate in an orally inhaled dry powder formulation (Asmanex Twisthaler - Schering-Plough) for maintenance treatment of asthma in patients at least 12 years old. Mometasone is also available as a mid-potency topical corticosteroid cream (Elocon) and as an intranasal spray (Nasonex) for treatment of allergic rhinitis.

Montelukast (Singulair - Merck) is an oral cysteinyl leukotriene D₄ receptor antagonist originally marketed for treatment of asthma. It was approved by the FDA in 2003 for treatment of seasonal allergic rhinitis and recently for use in perennial allergic rhinitis in adults and children ≥ 6 months old. Intranasal corticosteroids have generally been considered the most effective drugs available for prevention and treatment of allergic rhinitis.

The pathogenesis of acne is multifactorial: follicular hyperkeratinization, Propionibacterium acnes bacteria, sebum production, androgens and inflammation have all been implicated. P. acnes, a gram-positive microaerophilic bacterium, plays an important role in the development of acne lesions by secreting chemotactic factors that attract leukocytes to the follicle, causing inflammation.

Allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria and anaphylaxis, along with asthma (reviewed in Treatment Guidelines 2002; 1:7 and not included here), have increased in prevalence during the past 30 years and are now epidemic worldwide, especially in industrialized countries. Many safe and effective drugs are currently available for prevention and relief of symptoms in these disorders, but pharmacological treatment alone may not be sufficient. Patients should also be instructed to avoid specific allergens or environmental conditions that trigger their symptoms. Allergen-specific immunotherapy, parenteral administration of gradually increasing doses of the allergen ("allergy shots"), has been effective in allergic rhinitis, allergic conjunctivitis and allergic asthma, and also in prevention of anaphylaxis triggered by stings from bees, yellow jackets, hornets and wasps. It has not been effective in food allergy, atopic dermatitis or urticaria.

Montelukast (Singulair - Merck), a leukotriene receptor antagonist already marketed for asthma (Treatment Guidelines from The Medical Letter 2002; 1:11), has been approved by the FDA for treatment of seasonal allergic rhinitis in adults and children more than 2 years old.

An intranasal spray formulation of the corticosteroid fluticasone propionate (floo tik a sone; Flonase - Allen & Hanburys) has been approved by the US Food and Drug Administration for treatment of seasonal and perennial allergic rhinitis in adults and children more than 12 years old.

Two new topical corticosteroids - fluticasone (Cutivate - Glaxo), a mediumpotency product, and halobetasol propionate (Ultravate - Westwood-Squibb), a superhigh- potency drug- were recently approved for marketing by the US Food and Drug Administration.