Fluticasone propionate (Fp) and Fp/salmeterol (FS) have been developed in a novel multidose dry powder inhaler (MDPI) for patients with asthma.

Background Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development as a potential treatment for allergic rhinitis. The objective of this study was to determine the long-term safety and efficacy of CIC-HFA compared to placebo in subjects with perennial allergic rhinitis (PAR).

Background Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development as a potential treatment for allergic rhinitis. The objective of this study was to determine the efficacy and safety of CIC-HFA compared to placebo in subjects with perennial allergic rhinitis (PAR).

RATIONALE: Ciclesonide is a new intranasal corticosteroid indicated for the treatment of seasonal (≥6 years old) and perennial (≥12 years old) allergic rhinitis (AR). The long-term safety and efficacy of ciclesonide nasal spray in adolescents (12-17 years old) with perennial AR (PAR) was examined in a subgroup analysis.METHODS: A post hoc subgroup analysis of adolescents from a 52-week, double-blind, placebo-controlled, multicenter trial of ciclesonide treatment in 633 patients with PAR was conducted (Chervinsky 2007). Patients received ciclesonide 200μg or placebo QD for 52 weeks. Safety was monitored by treatment-emergent adverse events (TEAEs), cortisol measurements, and ocular examinations. Efficacy was assessed using patient-reported 24-hour reflective total nasal symptom scores (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ). Results: Seventy-eight patients (ciclesonide, n = 52; placebo, n = 26) were included in the subanalysis (mean age = 14.9 years). The proportion of TEAEs was comparable between groups (59.0% with ≥1TEAE). The most frequently reported TEAE was upper respiratory tract infection (ciclesonide, 15.4%; placebo, 23.1%); epistaxis was reported infrequently (ciclesonide, 3.8%; placebo, 7.7%). No clinically relevant changes in cortisol or ocular safety were noted for either group. Ciclesonide significantly improved 24-hour reflective TNSS compared with baseline(ciclesonide, −2.0[p < 0.001]; placebo, −1.3[p < 0.004]; treatment difference, 0.7[p = 0.085]). Ciclesonide improved RQLQ compared with baseline (ciclesonide, −0.7[p < 0.001]; placebo, −0.5[p < 0.040]; treatment difference, 0.2[p = 0.354]).CONCLUSIONS: Ciclesonide 200μg was safe and effective in adolescents for the long-term treatment of PAR. There were no clinically relevant changes in safety measures, suggesting a limited potential for systemic side effects. Furthermore, PAR symptom improvements were associated with health-related quality-of-life improvements compared with baseline. RATIONALE: Ciclesonide is a new intranasal corticosteroid indicated for the treatment of seasonal (≥6 years old) and perennial (≥12 years old) allergic rhinitis (AR). The long-term safety and efficacy of ciclesonide nasal spray in adolescents (12-17 years old) with perennial AR (PAR) was examined in a subgroup analysis. METHODS: A post hoc subgroup analysis of adolescents from a 52-week, double-blind, placebo-controlled, multicenter trial of ciclesonide treatment in 633 patients with PAR was conducted (Chervinsky 2007). Patients received ciclesonide 200μg or placebo QD for 52 weeks. Safety was monitored by treatment-emergent adverse events (TEAEs), cortisol measurements, and ocular examinations. Efficacy was assessed using patient-reported 24-hour reflective total nasal symptom scores (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ). Results: Seventy-eight patients (ciclesonide, n = 52; placebo, n = 26) were included in the subanalysis (mean age = 14.9 years). The proportion of TEAEs was comparable between groups (59.0% with ≥1TEAE). The most frequently reported TEAE was upper respiratory tract infection (ciclesonide, 15.4%; placebo, 23.1%); epistaxis was reported infrequently (ciclesonide, 3.8%; placebo, 7.7%). No clinically relevant changes in cortisol or ocular safety were noted for either group. Ciclesonide significantly improved 24-hour reflective TNSS compared with baseline (ciclesonide, −2.0[p < 0.001]; placebo, −1.3[p < 0.004]; treatment difference, 0.7[p = 0.085]). Ciclesonide improved RQLQ compared with baseline (ciclesonide, −0.7[p < 0.001]; placebo, −0.5[p < 0.040]; treatment difference, 0.2[p = 0.354]). CONCLUSIONS: Ciclesonide 200μg was safe and effective in adolescents for the long-term treatment of PAR. There were no clinically relevant changes in safety measures, suggesting a limited potential for systemic side effects. Furthermore, PAR symptom improvements were associated with health-related quality-of-life improvements compared with baseline.

Background: Ciclesonide is a corticosteroid in development for allergic rhinitis that has been shown to be safe and effective in seasonal allergic rhinitis and perennial allergic rhinitis (PAR) trials of up to 6 weeks in duration. However, the long-term safety and efficacy of ciclesonide are unknown.Objective: To demonstrate the long-term safety of intranasal ciclesonide, 200 mu g once daily, in patients with PAR.Methods: Patients (>= 12 years old) with a 2-year or longer history of PAR were randomized in a double-blind fashion to receive ciclesonide, 200 mu g, or placebo once daily in the morning for up to 52 weeks. Spontaneous and elicited adverse events were monitored throughout the study. Ear, nose, and throat examinations were performed to evaluate local tolerability. Additionally, 24-hour urinary free cortisol level, morning plasma cortisol level, intraocular pressure, and lens opacification were monitored to evaluate the systemic safety of intranasal ciclesonide. Ciclesonide efficacy was determined by measuring 24-hour reflective total nasal symptom scores.Results: No clinically relevant differences were observed between the ciclesonide and placebo groups in adverse events, ear, nose, and throat examinations, or 24-hour urinary free or morning plasma cortisol levels. Similarly, no clinically relevant differences were found between treatment groups in intraocular pressure, visual acuity, or lens opacification. With regard to efficacy, ciclesonide achieved a significantly greater reduction in 24-hour reflective total nasal symptom score compared with placebo over more than 52 weeks (P < .001).Conclusion: In this study, intranasal ciclesonide, 200 mu g once daily, was safe and effective for the long-term treatment of PAR, with no evidence of tachyphylaxis.

Background: Cromolyn sodium is a nonsteroidal inhaled antiinflammatory agent for the treatment of asthma, As with other pressurized aerosol medications, the metered-dose inhaler (MDI) formulation currently contains chlorofluorocarbon (CFC) propellants, Because of their harmful effects on the environment CFCs are now generally banned from production and use, Alternative propellants under production for MDIs include derivatives of hydrofluoroalkane (HFA). This study uses HFA-227 in an MDI formulation of cromolyn sodium.Objectives: The objectives of the study were (1) to examine the efficacy and safety of an HFA formulation of cromolyn sodium (Intal) MDI and (2) to compare the HFA formulation with the CFC formulation.Methods: A multicenter, randomized, double-blind, placebo-controlled, parallel study with two active groups (HFA-cromolyn sodium [n = 113] and CFC-cromolyn sodium [n = 107]) and a placebo-treated group (n = 105).Results: Patients treated with either formulation of cromolyn sodium MDI showed a statistically significant (p < 0.05) improvement of 12% to 18% compared with placebo in symptom summary score, daytime asthma symptoms, and albuterol use. No statistically significant differences were observed in pulmonary function. Patient and physician opinions of overall effectiveness favored HFA-cromolyn sodium over placebo (p = 0.01), with no other significant between-treatment differences. No statistically significant differences existed among groups in the incidence of treatment-related adverse events.Conclusion: The HFA formulation of cromolyn sodium MDI is a well-tolerated and active alternative treatment for asthma patients aged 12 years and more.

Tri-Nasal Nasal Spray is an investigational solution of triamcinolone acetonide (TAA) currently being evaluated as a treatment for allergic rhinitis. The safety and efficacy of 200 and 400 micrograms once daily doses of Tri-Nasal Nasal Spray, an active control (440 micrograms once daily of Nasacort Nasal aerosol), and Tri-Nasal Nasal Spray placebo were compared over a 2-week treatment period in a double-blind (the Nasacort treatment was not blinded), parallel design trial. A total of 377 adult patients in 13 centers were enrolled during the grass pollen season. The primary efficacy variable was the weekly average of the SSI (Symptom Severity Index), the sum of daily nasal congestion, rhinorrhea, and sneezing severity scores from the patient diary. A total of 355 patients completed the study. All active treatments were significantly more effective than placebo in relieving nasal symptoms at each treatment week. The 400 micrograms Tri-Nasal Nasal Spray and Nasacort treatments had a rapid onset of action, demonstrating significant improvement in the SSI versus placebo by the second day of treatment. Results for the individual nasal symptoms and other secondary efficacy measures paralleled those of the primary efficacy variables. Tri-Nasal Nasal Spray and Nasacort were comparable in safety, and in treating the nonocular symptoms of seasonal allergic rhinitis.

The consumption of certain foods causes watery rhinorrhea (gustatory rhinitis) in many individuals. To examine the underlying mechanisms responsible for this common phenomenon, 12 subjects ingested control foods and positive foods (foods that cause rhinorrhea). Nasal lavages performed 10 minutes after each food challenge were analyzed for albumin and total protein. Positive food challenge, but not control food challenge, induced rhinorrhea in all subjects. Positive food challenge increased albumin (7.8 +/- 1.9 to 24.5 +/- 7.6 mg/L; p less than 0.025) and total protein (79 +/- 9 to 258 +/- 41 mg/L; p less than 0.001) without altering the ratio of albumin to total protein (albumin percent). Nasal pretreatment with atropine clinically blocked the positive food-induced rhinorrhea and significantly inhibited secretion of both albumin and total protein, again without affecting the albumin percent. Thus, gustatory rhinitis is produced by spicy foods that stimulate atropine-inhibitable muscarinic receptors (probably on submucosal glands), and the syndrome can be treated prophylactically by use of topical atropine.

Recurrent idiopathic anaphylaxis is an illness consisting of recurring anaphylactic or anaphylactoid attacks of unknown cause. A patient has been described whose attacks appeared to be associated with endogenous progesterone secretion and who was treated successfully with an analog of luteinizing hormone-releasing hormone (LHRH). This report summarizes the treatment of four additional women with recurrent anaphylaxis in a randomized, double-blind trial of an LHRH agonist and placebo. Two out of the four women experienced remission of their symptoms with the LHRH analog. The patients who responded to therapy had experienced systemic anaphylactoid reactions after provocation with an LHRH infusion and the intradermal injection of medroxyprogesterone; the nonresponders had no adverse reactions to either challenge. Ovarian suppression with LHRH agonist may benefit a subset of women with recurrent idiopathic anaphylaxis.

Allergic reactions involving the pharyngeal lymphoid tissues are thought to play a role in several clinical disorders seen commonly in ear, nose, and throat surgical practices. The pathogenesis of the allergic reaction is discussed in relationship to disorders involving the tonsillar tissues, the upper airways and nasopharynx, and the ear.