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Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD.

BACKGROUND: Consistent delivery of medication to treat asthma and chronic obstructive pulmonary disease (COPD) is critical for disease control. Dose tracking may eliminate the possibility of sub-therapeutic dosing. This study evaluated the overall performance, including accuracy and ruggedness, of the mometasone furoate/formoterol (MF/F) metered-dose inhaler (MDI) with an integrated numerical dose-counting mechanism in adolescent and adult subjects (aged ≥12 y) with persistent asthma or COPD.

METHODS: In a phase III, open-label, single-arm, multicenter study, subjects demonstrating at least 90% compliance with MF/F during the screening period received twice daily MF/F MDI 100/10 μg with the integrated dose counter for 4 weeks. Accuracy and ruggedness of the dose counter were assessed by the overall discrepancy rate of subject-recorded actuations versus subject-recorded dose counter readings. Discrepancy rates for Counterstrip™, a manual counting method, were evaluated for reference. Compliance and ergonomic safety were also assessed.

RESULTS: The 233 subjects who used ≥90% of labeled actuations were included in the primary analysis. Of 26,317 total actuations, 33 dose counter discrepancies occurred (rate = 0.13/100 actuations), of which 13 were due to undercounting. In comparison, the Counterstrip discrepancy rate was 10-fold higher (1.34/100 actuations). Compliance with medication use, Counterstrip use, and e-diary recordings were all high (>98%). No new repetitive strain injuries or exacerbations of preexisting ergonomic injuries of the finger, hand, or arm were reported.

CONCLUSIONS: The MF/F MDI dose counter was accurate and rugged in subjects with asthma or COPD. No new repetitive strain injuries or exacerbations of existing ergonomic injuries were associated with inhaler use. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier = NCT00604500.

Systemic nickel hypersensitivity and diet: myth or reality?

Nickel is a very common metal contained in many everyday objects and is the leading cause of ACD (Allergic Contact Dermatitis). Nickel is present in most of the constituents of a normal diet, but some food groups are usually considered to be richer. However, the nickel content of specific food can vary widely, depending on many factors. Thus, the daily intake of nickel is also highly variable both among different populations and in a single individual, in different seasons and even in different days. Measuring precisely the daily intake of nickel from food and drinks is extremely difficult, if not impossible.

The relationship between ACD and contact with nickel is undisputed and widely confirmed in literature. The situation is different for systemic nickel allergy syndrome (SNAS). The SNAS can have cutaneous signs and symptoms (Systemic Contact Dermatitis or SCD) or extracutaneous signs and symptoms (gastrointestinal, respiratory, neurological, etc.).The occurrence of SCD as a systemic reaction to the nickel normally assumed in the daily diet is very controversial. A rigorous demonstration of the relationship between SCD and nickel is extremely difficult. In particular, further and larger studies are needed to assess the reality and the prevalence of nickel urticaria. With respect to nickel-related gastrointestinal symptoms, as well as chronic fatigue syndrome, fibromyalgia, headache, recurring cold sores and recurrent infections in general, the data available in literature are not conclusive and the studies lack the support of clear, first-hand evidence.

With respect to respiratory disorders, the role of food nickel and the effectiveness of a dietary treatment have been assumed but not proven. In fact, the usefullness of a therapeutic low-nickel diet is controversial: rare, if not exceptional, and limited to very sporadic cases of SCD. Additionally, the quantitative and qualitative composition of a low-nickel diet presents few certainties and many uncertainties. The low-nickel diets suggested in literature are highly variable, both in the extension of the restrictions and in their details--and the differences are not marginal.

CONCLUSION: an evaluation of the data presented by medical literature about SNAS and its relationship with oral nickel does not allow to draw final conclusions. In the absence of genuine certainty we can only conclude that further and broader studies, more rigorously conducted, are needed.

Relationships between repeated instruction on inhalation therapy, medication adherence, and health status in chronic obstructive pulmonary disease.

Adherence to inhalation therapy is a critical determinant of the success of chronic obstructive pulmonary disease (COPD) management. However, in practice, nonadherence to inhalation therapy is very common in COPD patients. The effects of adherence to inhalation therapy in COPD have not been fully studied, and less is known about the relationship between medication adherence and quality of life in COPD.

Our aim is to assess the factors that contribute to adherence to inhalation therapy and examine their correlation with quality of life.

Nontypeable Haemophilus influenzae in chronic obstructive pulmonary disease and lung cancer.

Chronic obstructive pulmonary disease (COPD) is predicted to become the third leading cause of death in the world by 2020. It is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles and gases, most commonly cigarette smoke.

Among smokers with COPD, even following withdrawal of cigarette smoke, inflammation persists and lung function continues to deteriorate. One possible explanation is that bacterial colonization of smoke-damaged airways, most commonly with nontypeable Haemophilus influenzae (NTHi), perpetuates airway injury and inflammation. Furthermore, COPD has also been identified as an independent risk factor for lung cancer irrespective of concomitant cigarette smoke exposure.

In this article, we review the role of NTHi in airway inflammation that may lead to COPD progression and lung cancer promotion.

Early detection of COPD in general practice.

Early detection enables the possibility for interventions to reduce the future burden of COPD. The Danish National Board of Health recommends that individuals >35 years with tobacco/occupational exposure, and at least 1 respiratory symptom should be offered a spirometry to facilitate early detection of COPD. The aim, therefore, was to provide evidence for the feasibility and impact of doing spirometry in this target population.

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