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Efficacy and safety profile of fluticasone/formoterol combination therapy compared to its individual components administered concurrently in asthma: a randomised controlled trial.

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Efficacy and safety profile of fluticasone/formoterol combination therapy compared to its individual components administered concurrently in asthma: a randomised controlled trial.

Curr Med Res Opin. 2013 Feb 1;

Authors: Bodzenta-Lukaszyk A, van Noord J, Schröder-Babo W, McAulay K, McIver T

Abstract
Abstract Background The potent inhaled corticosteroid, fluticasone propionate (fluticasone), and the long-acting β(2)-agonist with a rapid onset of action, formoterol fumarate (formoterol), have now been combined in a single aerosol inhaler (fluticasone/formoterol; FLUTIFORM*). This study investigated the efficacy and safety of fluticasone/formoterol combination therapy compared with its individual components administered concurrently via two separate inhalers. Methods Patients ≥12 years (N=210) with mild to moderate-severe persistent, reversible asthma were evenly randomised to 12 weeks of treatment (b.i.d.) with fluticasone/formoterol combination therapy (100/10μg b.i.d. or 250/10μg b.i.d.) or fluticasone plus formoterol (FLIXOTIDE EVOHALER* [pMDI], (FLOVENT [HFA]), GlaxoSmithKline; FORADIL* [DPI], (FORADIL AEROLIZER), Merck & Co, respectively) administered concurrently (fluticasone+formoterol; 100μg + 12μg b.i.d. or 250μg + 12μg b.i.d.) in an open-label, parallel-group, multicentre study. The primary objective of this study was to show non-inferiority of fluticasone/formoterol compared with fluticasone+formoterol based on mean post-dose FEV(1). Results The mean FEV(1) 30 to 60 minutes post-dose on Day 84 was approximately 2.6L in both the fluticasone/formoterol combination and the fluticasone+formoterol treatment groups (per protocol sets; treatment difference least squares (LS) mean: -0.03 L; 95% CI: -0.148, 0.081). The lower limit of the 95% CI (-0.148 L) was above the non-inferiority threshold of ≥-0.2 L. Analyses of other pulmonary function tests, patient reported outcomes, rescue medication use, asthma exacerbations and quality of life questionnaires were also comparable. The safety profiles of the two study groups were similar overall. Conclusions Fluticasone/formoterol combination therapy had comparable efficacy to its individual components administered concurrently, when measured by post-dose FEV(1) in patients aged ≥12 years with mild to moderate-severe asthma. The safety and tolerability profile of fluticasone/formoterol combination therapy was similar to that of its individual components administered concurrently. Although this was an open-label study, the results remain compelling: the primary efficacy measure was a physical endpoint and study statisticians were blinded to treatment allocations until analysis was completed.

PMID: 23368897 [PubMed - as supplied by publisher]

Integrating the Overlap of Obstructive Lung Disorders with Obstructive Sleep Apnea: OLDOSA Syndrome.

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Integrating the Overlap of Obstructive Lung Disorders with Obstructive Sleep Apnea: OLDOSA Syndrome.

Respirology. 2013 Jan 31;

Authors: Ioachimescu OC, Teodorescu M

Abstract
Obstructive lung disorders (OLDs), such as asthma and chronic obstructive pulmonary disease (COPD) are very prevalent conditions. Disease phenotypes (e.g., chronic bronchitis, emphysema, etc) often overlap, and significant confusion exists about their optimal nosologic characterization. Obstructive sleep apnea (OSA) is also a common condition, which features bidirectional interactions with OLDs. OSA appears to be more commonly seen in patients with OLD, perhaps as a result of shared risk factors, e.g., obesity, smoking, increased airway resistance, local and systemic inflammation, anti-inflammatory therapy. Conversely, OSA is associated with worse clinical outcomes in patients with OLD, and continuous positive airway pressure (CPAP) therapy has potential beneficial effects on this vicious pathophysiologic interaction. Possible shared mechanistic links include increased parasympathetic tone, hypoxemia-related reflex bronchoconstriction/vasoconstriction, irritation of upper airway neural receptors, altered nocturnal neurohormonal secretion, pro-inflammatory mediators, within and inter-breath interactions between upper and lower airways, lung volume-airway dependence, etc. While the term overlap syndrome has been defined as the comorbid association of COPD and OSA, the interaction between asthma and OSA has not been integrated yet nosologically; in this review we will be calling the latter alternative overlap syndrome. In an effort to bolster further investigations in this area, we propose here an integrated, lumping nomenclature for OSA in the setting of OLD - OLDOSA (Obstructive Lung Disorder and Obstructive Sleep Apnea) syndrome.

PMID: 23368952 [PubMed - as supplied by publisher]

The skin prick test -- European standards.

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The skin prick test -- European standards.

Clin Transl Allergy. 2013 Feb 1;3(1):3

Authors: Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wöhrl S, Maibach H, Lockey R

Abstract
ABSTRACT: Skin prick testing is an essential test procedure to confirm sensitization in IgE-mediated allergic disease in subjects with rhinoconjunctivitis, asthma, urticaria, anapylaxis, atopic eczema and food and drug allergy. This manuscript reviews the available evidence including Medline and Embase searches, abstracts of international allergy meetings and position papers from the world allergy literature.The recommended method of prick testing includes the appropriate use of specific allergen extracts, positive and negative controls, interpretation of the tests after 15 -- 20 minutes of application, with a positive result defined as a wheal >=3 mm diameter. A standard prick test panel for Europe for inhalants is proposed and includes hazel (Corylus avellana), alder (Alnus incana), birch (Betula alba), plane (Platanus vulgaris), cypress (Cupressus sempervirens), grass mix (Poa pratensis, Dactilis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Helictotrichon pretense), Olive (Olea europaea), mugwort (Artemisia vulgaris), ragweed (Ambrosia artemisiifolia), Alternaria alternata (tenuis), Cladosporium herbarum, Aspergillus fumigatus, Parietaria, cat, dog, Dermatophagoides pteronyssinus, Dermatophagoides farinae, and cockroach (Blatella germanica).Standardization of the skin test procedures and standard panels for different geographic locations are encouraged worldwide to permit better comparisons for diagnostic, clinical and research purposes.

PMID: 23369181 [PubMed - as supplied by publisher]

Inhaled Corticosteroids in Lung Diseases.

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Inhaled Corticosteroids in Lung Diseases.

Am J Respir Crit Care Med. 2013 Jan 31;

Authors: Raissy HH, Kelly HW, Harkins M, Szefler SJ

Abstract
Inhaled corticosteroids are used extensively in the treatment of asthma and chronic obstructive lung disease due to their demonstrated efficacy in reducing exacerbations and improving overall control. Their beneficial effect is based on their broad anti-inflammatory and immunosuppressive effects. The available inhaled corticosteroids vary in their therapeutic index based on individual drug potency, pharmacokinetics and specific delivery system. Although ICS are used in all age groups including children, younger and smaller children may be at a greater risk for adverse systemic effects as they can receive higher mg/kg doses of ICSs compared to older children. Most of the benefit from ICSs occurs in the low-medium dose range with minimal additional improvement with higher doses, although some patients may benefit from these higher doses. While ICS are the preferred agents for managing persistent asthma in all ages, their benefit in COPD is less convincing. When used appropriately, ICSs have few adverse events at low-medium doses but risk increases with high dose ICS. Although several new drugs are being developed and evaluated, it is unlikely that any of these new medications will replace ICS as the preferred initial long-term controller therapy for asthma but more effective initial controller therapy could be developed for COPD.

PMID: 23370915 [PubMed - as supplied by publisher]

Role of Skin Prick Test in Allergic Disorders: A Prospective Study in Kashmiri Population in Light of Review.

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Role of Skin Prick Test in Allergic Disorders: A Prospective Study in Kashmiri Population in Light of Review.

Indian J Dermatol. 2013 1;58(1):12-17

Authors: Rasool R, Shera IA, Nissar S, Shah ZA, Nayak N, Siddiqi MA, Sameer AS

Abstract
BACKGROUND: Skin prick test (SPT) is the most effective diagnostic test to detect IgE mediated type I allergic reactions like allergic rhinitis, atopic asthma, acute urticaria, food allergy etc. SPTs are done to know allergic sensitivity and applied for devising immunotherapy as the therapeutic modality. MATERIALS AND METHODS: This prospective study was conducted in the department of Immunology and Molecular medicine at SKIMS. A total of 400 patients suffering from allergic rhinitis, asthma and urticaria were recruited in this study. SPT was performed with panel of allergens including house dust mite, pollens, fungi, dusts, cockroach, sheep wool and dog epithelia. Allergen immunotherapy was given to allergic rhinitis and asthmatic patients as therapeutic modality. RESULTS: In our study, age of patients ranged from 6 to 65 years. Majority of patients were in the age group of 20-30 years (72%) with Male to female ratio of 1:1.5. Of the 400 patients, 248 (62%) had urticaria, 108 (27%) patients had allergic rhinitis and 44 (11%) patients had asthma. SPT reaction was positive in 38 (86.4%) with allergic asthma, 74 (68.5%) patients with allergic rhinitis and 4 (1.6%) patient with urticaria, respectively. Allergen immunotherapy was effective in 58% patients with allergic rhinitis and 42% allergic asthma. CONCLUSION: Identifiable aeroallergen could be detected in 86.4% allergic asthma and 68.5% allergic rhinitis patients by SPT alone. Pollens were the most prevalent causative allergen. There was significant relief in the severity of symptoms, medication intake with the help of allergen immunotherapy.

PMID: 23372205 [PubMed - as supplied by publisher]

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