A non-interventional switch study in adult patients with asthma or COPD on clinical effectiveness of salmeterol/fluticasone Easyhaler in routine clinical practice.

Background: Selection of the most appropriate device for a switch from one inhaler to an equivalent product is known to have a major impact on clinical outcomes in patients with asthma or chronic obstructive pulmonary disease (COPD). Salmeterol/fluticasone propionate (S/F) Easyhaler has been demonstrated to be therapeutically equivalent with a reference product. However, no data on real-life effectiveness are currently available for patients switching to S/F Easyhaler from another S/F inhaler.

Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma.

Background: Therapeutic equivalence of Budesonide/formoterol Easyhaler compared to Symbicort Turbuhaler has been previously demonstrated with in vitro and pharmacokinetic studies. This study was performed to confirm equivalent bronchodilator efficacy of the products in asthmatic patients.

Methods: A randomised, single-dose, 4-period crossover study was carried out in a double-blind, double-dummy manner in 11 study sites.

Equivalent Lung Dose and Systemic Exposure of Budesonide/Formoterol Combination via Easyhaler and Turbuhaler.

Background: Easyhaler(®) device-metered dry powder inhaler containing budesonide and formoterol fumarate dihydrate (hereafter formoterol) for the treatment of asthma and chronic obstructive pulmonary disease has been developed. The current approvals of the product in Europe were based on several pharmacokinetic (PK) bioequivalence (BE) studies, and in vitro-in vivo correlation (IVIVC) modeling.

Methods: Four PK studies were performed to compare the lung deposition and total systemic exposure of budesonide and formoterol after administration of budesonide/formoterol Easyhaler and the reference product, Symbicort Turbuhaler.

Colonic methane production modifies gastrointestinal toxicity associated with adjuvant 5-fluorouracil chemotherapy for colorectal cancer.

Goals: To investigate the association of colonic methane, formed by methanogenic achaea, and pH with gastrointestinal symptoms during colorectal cancer chemotherapy.

Background: Adjuvant 5-fluorouracil chemotherapy reduces recurrences in colorectal cancer, but causes severe gastrointestinal toxicity, partly related to disturbed intestinal microbiota.

Study: Resected colorectal cancer patients (n=143) were analyzed for colonic methanogenesis and pH before and during the 24 weeks of 5-fluorouracil chemotherapy and for gastrointestinal symptoms during chemotherapy.

Colonic methanogenesis in vivo and in vitro and fecal pH after resection of colorectal cancer and in healthy intact colon.

Purpose: We compared colonic methanogenesis in vivo and in vitro as well as fecal pH in healthy subjects and in patients with resected colorectal cancer thus without the possible confounding effects of the tumor.

Methods: A total of 144 subjects, 96 with resected colorectal cancer (of whom, 48 were with metastatic disease), 48 healthy subjects with intact colon, were analyzed for breath methane, fecal methanogenesis in vitro and fecal pH. In addition, the association between methanogenesis and pH with cancer site, operation technique and abdominal discomfort was investigated.

Comparison of polyethylene glycol with and without electrolytes in the treatment of constipation in elderly institutionalized patients: a randomized, double-blind, parallel-group study.

Background: Polyethylene glycol (PEG) is a commonly used osmotic laxative. PEG with electrolytes is mixed with water, but PEG without electrolytes can also be mixed with, for example, juice, coffee or tea, making it more palatable. Laxatives, including PEG, are commonly used by the elderly, particularly those living in institutions.

The effect of probiotic fermented milk and inulin on the functions and microecology of the intestine.

We investigated the effects of a probiotic fermented milk and inulin on gastrointestinal function and microecology. The study was double-blinded and comprised 66 healthy adults (22 male, 44 female), mean age 40 years (range, 22-60 years). After a 12-d baseline period the subjects were randomized to consume, for 3 weeks, 3x200 ml daily of either (1) a fermented milk with probiotics (Bifidobacterium longum BB536, Bifidobacterium spp.

Yoghurt containing galacto-oligosaccharides, prunes and linseed reduces the severity of mild constipation in elderly subjects.

Objective: Constipation is a common problem in the elderly. Dietary fibre is recommended for its treatment. The aim was to examine whether yoghurt containing galacto-oligosaccharides (GOS), prunes and linseed relieve constipation in elderly subjects.

Correct use of three powder inhalers: comparison between Diskus, Turbuhaler, and Easyhaler.

A Phase IV, 4-week, open, randomized multicenter parallel group trial compared correct use and acceptability of Diskus, Turbuhaler, and Easyhaler powder inhalers among 326 inhaler naive asthmatics/symptomatics. The subjects were asked to read the instruction leaflet before taking one dose at the first visit. The correct use was evaluated when the subject took the dose.

Efficacy of salbutamol via Easyhaler unaffected by low inspiratory flow.

The fine particle dose delivered via dry powder inhalers (DPIs) is often affected by the inspiratory flow rate generated during inhalation. This has clinical implications, since the fine particle dose determines the amount of drug reaching the lungs. With Easyhaler DPI the fine particle dose remains relatively constant over the range of inspiratory flow rates from 30-60 l min(-1).