24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD.

Background: Symptoms of chronic obstructive pulmonary disease may vary throughout the day and it is important that therapeutic approaches provide 24-h symptom control. We report the results of two phase IIIb crossover studies, PT003011 and PT003012, investigating the 24-h lung function profile of GFF MDI (glycopyrrolate/formoterol fumarate 18/9.6 μg delivered using innovative co-suspension delivery technology) administered twice daily.

Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD.

Background: Long-acting muscarinic antagonist (LAMA)/long-acting β-agonist (LABA) combinations are a treatment option for patients with COPD who continue to have symptoms despite treatment with a LAMA or a LABA alone. The Efficacy and Safety of PT003, PT005, and PT001 in Subjects with Moderate-to-Very Severe COPD (PINNACLE-1) (NCT01854645) and the Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects with Moderate-to-Very Severe COPD (PINNACLE-2) (NCT01854658) trials investigated the efficacy and safety of a novel glycopyrrolate [GP]/formoterol [FF] 18/9.6-μg (GFF) metered dose inhaler (MDI) formulated using the Co-Suspension Delivery Technology in patients with moderate-to-very severe COPD.

A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD.

Background: This study formed part of the dose selection for a glycopyrrolate (GP)/formoterol fumarate (FF) fixed-dose combination formulated using novel Co-Suspension™ Delivery Technology and delivered via a metered dose inhaler (GFF MDI). The study aimed to confirm the optimal dose of GP to formulate with FF 9.6 μg in the fixed-dose combination product, GFF MDI.

[Treatment of toxic epidermal necrolysis. Experience with 9 patients with consideration of intravenous immunoglobulin].

Toxic epidermal necrolysis (TEN) is the maximal variant of severe bullous drug reactions with a high mortality rate of 30-40%. Treatment should be interdisciplinary and is best provided in an intensive care setting. Since no specific therapy has been established, supportive intensive care and topical treatment are of crucial importance.

Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma.

Background: Although inhaled glucocorticoids are recommended for all stages of persistent asthma, compliance with long-term therapy is often poor, leading to significant morbidity and mortality. A simplified, once-daily dosing regimen may foster improved compliance.

Objective: To compare the efficacy and safety of once-daily (AM) administration of mometasone furoate dry powder inhaler (MF DPI) 200 microg and 400 microg with placebo in patients with asthma previously maintained only on short-acting inhaled beta-adrenergic receptor agonists.

Oral immunotherapy with short ragweed extract in a novel encapsulated preparation: a double-blind study.

Background: In the past, oral immunotherapy with allergens has had limited clinical effectiveness, presumably because of gastrointestinal destruction of allergens.

Objective: We have developed a new technique for microencapsulating protein antigens that permits them, when given orally, to bypass the stomach and be delivered to the small intestine in a highly immunogenic form. This study's purpose was to confirm the immunologic potency of orally administered short ragweed pollen extracts (SRW) microencapsulated (mSRW) by this new technique and to study the effectiveness of mSRW in controlling the symptoms of ragweed-induced hay fever.

Immunologic effects of encapsulated short ragweed extract: a potent new agent for oral immunotherapy.

Background: Oral allergen immunotherapy with conventional allergens has not been a useful mode of treatment because of the lack of potency of allergens when administered by this route.

Objective: To study the immunologic potency of short ragweed pollen extracts microencapsulated by a new technique administered orally to short ragweed pollen-sensitive humans and to establish the dose of oral microencapsulated short ragweed pollen extract required for these effects.

Methods: Nine short ragweed pollen-sensitive patients were treated with a new oral agent for immunotherapy, microencapsulated short ragweed pollen extract, in an open study.

Inflammatory cells and mediator release during ragweed challenge: correlation between histamine content in nasal secretions and appearance of inflammatory cells.

The early and late phase responses in the nasal tissues exhibit release of inflammatory mediators and a mixed cellular influx in separate nasal challenges. To explore this phenomenon further, histamine concentration was determined along with characterization of cell influx during dose-dependent ragweed challenges. Ten subjects with allergic rhinitis underwent two unilateral nasal lavages using incremental 3-fold concentrations of short ragweed.

Nasal inflammatory mediator release in ragweed allergic rhinitis: correlation with cellular influx into nasal secretions.

Lipid-derived mediators are found in nasal secretions during the early and late phase of allergic responses. To explore this early response further, concentrations of inflammatory mediators were measured along with characterization of specific cell influx during dose-dependent ragweed challenges. Ten allergic rhinitis subjects underwent two unilateral nasal lavages using 3-fold concentrations of short ragweed antigen.

Adverse reactions to protamine sulfate during cardiac surgery in diabetic and non-diabetic patients.

The incidence of adverse reactions to protamine sulfate range from 0.06% to 27% and vary from mild urticaria to anaphylactic shock and death. In a retrospective analysis of 2996 patients, only four subjects experienced an adverse reaction due to protamine.