Safety, tolerability and pharmacokinetics of single escalating doses of indacaterol, a once-daily beta2-agonist bronchodilator, in subjects with COPD.

Objectives: To assess the safety and tolerability of 4 doses of indacaterol, a once-daily beta2-agonist, in subjects with chronic obstructive pulmonary disease (COPD). The 24-h bronchodilator effect and pharmacokinetics of indacaterol were also investigated.

Methods: 16 subjects aged 43 - 72 years with mild/moderate COPD were each given single doses of indacaterol of 400, 1,000, 2,000 and 3,000 µg, via a single-dose dry powder inhaler.

A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metered-dose inhaler in asthmatic subjects.

Background: The short-acting beta(2)-agonists levalbuterol and racemic albuterol are available for administration through a hydrofluoroalkane-134a (HFA) metered-dose inhaler (MDI).

Objective: This study compared the short-term safety and efficacy of cumulative doses of levalbuterol HFA MDI and racemic albuterol HFA MDI in asthmatic subjects.

Methods: This was a randomized, modified-blind, active-controlled, multicenter, 2-way crossover study.

Efficacy and safety of an extended-release formulation of desloratadine and pseudoephedrine vs the individual components in the treatment of seasonal allergic rhinitis.

Background: Antihistamine-decongestant combination products generally provide more benefit than individual components for adequately treating patients who have seasonal allergic rhinitis (SAR) with moderate-to-severe nasal congestion.

Objective: To compare the effectiveness and safety of a 24-hour, extended-release formulation of desloratadine and pseudoephedrine with the individual components in patients who have SAR with moderate-to-severe nasal congestion.

Methods: Patients with SAR and significant nasal congestion were enrolled in a multicenter, randomized, double-blind, double-dummy study.

Pairwise comparison of levalbuterol versus racemic albuterol in the treatment of moderate-to-severe asthma.

The object of this study is a post hoc pairwise comparison of levalbuterol versus racemic albuterol for asthma in a multicenter, double-blind, randomized, placebo-controlled clinical trial. The participants are patients > or =12 years of age (n = 362) with FEV1 45-70% of predicted. The patients received nebulized levalbuterol (0.

Formoterol delivered via the dry powder Aerolizer inhaler versus albuterol MDI and placebo in mild-to-moderate asthma: a randomized, double-blind, double-dummy trial.

The objectives of this study were to compare the efficacy and tolerability of twice-daily formoterol dry powder 12 microg and 24 microg (Foradil) delivered via Aerolizer inhaler with four times daily albuterol (salbutamol) 180 microg delivered via metered dose inhaler (MDI) and placebo. A total of 554 adolescents and adults (ages 12-75 years) with mild-to-moderate asthma were randomized to this 12-week, multicenter, double-blind, double-dummy, placebo-controlled, parallel-group study. Twelve-hour spirometry measurements were taken at weeks 0, 4, 8, and 12.

Diskus and diskhaler: efficacy and safety of fluticasone propionate via two dry powder inhalers in subjects with mild-to-moderate persistent asthma.

Background: Fluticasone propionate is a topically active glucocorticoid with potent antiinflammatory activity in the treatment of asthma.

Objective: This study evaluated the safety and efficacy of fluticasone propionate administered via the Diskus and Diskhaler powder delivery devices in subjects with mild-to-moderate asthma.

Methods: Fluticasone propionate (500 microg twice daily) or placebo was administered via the Diskus and Diskhaler to 213 adolescent and adult asthma subjects in a randomized, double-blind, double-dummy, parallel-group study for 12 weeks.

Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma.

Background: Racemic albuterol is an equal mixture of (R)-albuterol (levalbuterol), which is responsible for the bronchodilator effect, and (S)-albuterol, which provides no benefit and may be detrimental.

Objective: We sought to compare 2 doses of a single enantiomer, levalbuterol (0.63 mg and 1.

A controlled trial of twice daily triamcinolone oral inhaler in patients with mild-to-moderate asthma.

Background: National and international guidelines recommend inhaled anti-inflammatory medications for patients with all but the mildest forms of asthma. Patients may also be more compliant with twice daily dosing.

Objective: To evaluate the efficacy and safety of triamcinolone acetonide (triamcinolone acetonide), 400 microg bid, in mild-to-moderate asthma patients.

Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma. The Fluticasone Propionate Asthma Study Group.

Background: Recent emphasis on the control of airway inflammation in asthma highlights the need for safe and effective antiinflammatory agents. Fluticasone propionate is one of the most potent antiinflammatory corticosteroids developed to date.

Objective: This study assessed the safety and efficacy of fluticasone propionate aerosol in the treatment of mild to moderate asthma.

Zomepirac sodium (Zomax) hypersensitivity in aspirin-sensitive asthmatics.

Three asthmatic patients with a history of bronchoconstriction after aspirin ingestion were challenged with a new analgesic, zomepirac sodium (Zomax), for determination of sensitivity to this drug. Each patient had previously demonstrated sensitivity to aspirin during oral provocative challenges. In all 3 patients, zomepirac produced the typical asthmatic and nasal response, indicating hypersensitivity.

Aspirin-sensitive rhinosinusitis asthma: a double-blind crossover study of treatment with aspirin.

Twenty-five ASA-sensitive patients with rhinosinusitis asthma underwent oral ASA challenges followed by desensitization to the adverse respiratory effects of ASA. We then compared the efficacy of continuous ASA treatment for their respiratory tract disease to that of a placebo treatment during a double-blind crossover study. For this group of 25 patients, there was significant improvement in nasal symptoms and a reduction in use of nasal beclomethasone during the months when they received ASA treatment.

The absence of detectable complement activation in aspirin-sensitive asthmatic patients during aspirin challenge.

Activation of complement was sought by two independent assay methods, total hemolytic complement (CH50) and C4 activation by rocket immunoelectrophoresis for C4d and C4 in plasma samples obtained from 16 aspirin-sensitive asthmatic patients and four control subjects during provocative oral aspirin challenges. No consistent evidence of significant complement activation was detected in either the asthmatic or control groups when serial measurements were performed. The measurements of CH50 and C4 activation did not change in either arterial or venous samples.

Aspirin-sensitive rhinosinusitis: the clinical syndrome and effects of aspirin administration.

Nineteen aspirin sensitive adult patients were identified who experienced naso-ocular responses without associated bronchospasm during standardized oral aspirin challenge. These 19 patients exhibited the characteristics of the aspirin triad except asthma. These included hypertrophic rhinitis with or without associated nasal polyps, abnormal sinus roentgenograms, nasal eosinophilia, aspirin-provoked responses of the upper airway identical to those observed in aspirin-sensitive asthmatics, capacity of the upper airway to be desensitized to aspirin, and cross-reactivity and/or cross-desensitization of the upper airway to indomethacin.

Aspirin-sensitive rhinosinusitis/asthma: spectrum of adverse reactions to aspirin.

In order to determine the types of respiratory responses observed during aspirin-induced reactions, 50 consecutive asthmatic patients with a history of aspirin sensitivity underwent prospective oral aspirin challenges between 1979 and 1981. Oral aspirin challenges produced 36 asthmatic responses (33 combined with rhinitis and three purely asthmatic) and six acute rhinoconjunctivitis responses (three combined with mild asthma and three purely rhinoconjunctivitis) but failed to stimulate any reaction in eight patients. The results produced by these challenges were then compared with results recorded during additional aspirin challenges in 28 of these patients, performed after the index challenge in 1979-1981 in 26 patients and in the case of two patients before 1979.

Aspirin desensitization in aspirin-sensitive asthmatic patients: clinical manifestations and characterization of the refractory period.

Thirty aspirin-sensitive asthmatic patients underwent incremental, oral aspirin challenge until a "positive reaction" (delta FEV1 greater than or equal to 25%) occurred. After this reaction, aspirin was readministered in an attempt to achieve "desensitization." This was defined as the ability of the patient to ingest 650 mg of aspirin without experiencing upper or lower respiratory-tract symptoms or a decrease in lung function.