20 research outputs found
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A 28-day clinical trial of aerosolized hyaluronan in alpha-1 antiprotease deficiency COPD using desmosine as a surrogate marker for drug efficacy
A previous 2-week clinical trial of aerosolized hyaluronan (HA) in COPD showed a rapid reduction in lung elastic fiber breakdown, as measured by sputum levels of the unique elastin crosslinks, desmosine and isodesmosine (DID). To further assess the therapeutic efficacy of HA and the utility of DID as surrogate markers for the development of pulmonary emphysema, we have conducted a 28-day randomized, double-blind, placebo-controlled, phase 2 trial of HA involving 27 subjects with alpha-1 antiprotease deficiency COPD.The study drug consisted of a 3 ml inhalation solution containing 0.03% HA with an average molecular weight of 150 kDa that was self-administered twice daily. DID levels were measured in urine, sputum, and plasma using tandem mass spectrometry.Free urine DID in the HA group showed a significant negative correlation with time between days 14 and 35 (r = -1.0, p = 0.023) and was statistically significantly decreased from baseline at day 35 (15.4 vs 14.2 ng/mg creatinine, p = 0.035). A marked decrease in sputum DID was also seen in the HA group between days 1 and 28 (0.96 vs 0.18 ng/mg protein), but the difference was not significant, possibly due to the small number of adequate specimens. Plasma DID remained unchanged following HA treatment and no significant reductions in urine, sputum, or plasma DID were seen in the placebo group.The results support additional clinical trials to further evaluate the therapeutic effect of HA and the use of DID as a real-time marker of drug efficacy.•Aerosolized hyaluronan (HA) was given to alpha-1 antiprotease deficient COPD patients for 28 days without significant adverse effects.•Treatment with HA (but not placebo) significantly decreased free desmosine in urine, consistent with reduced lung elastic fiber injury.•The findings support further investigation of the therapeutic effect of HA in COPD and the use of desmosine as a biomarker for drug efficacy
A qualitative analysis of mindfulness-based cognitive therapy (MBCT) in Parkinson's disease.
Objectives: To analyse the experiences of participants with Parkinson's disease (PD), who participated in an 8-week mindfulness-based cognitive therapy (MBCT) course. Design and method: Interpretative phenomenological analysis guided the design and method used in this study. A total of twelve participants (seven men and five women) with PD were recruited prior to and following participation in an MBCT course and interviewed with a semi-structured interview schedule. One participant who opted out of the course was also interviewed. The researcher also participated in another MBCT course to enhance their understanding of the participants' experience, keeping a detailed diary as a means of acknowledging bias in the analysis process. Themes were summarized from transcripts and later classified into superordinate themes, which were compared across all cases. Transcripts were also read and analysed by a second author and participants were given the opportunity to comment upon emerging themes. Results: Major themes included (1) changing patterns of coping; (2) the role of mindfulness in consolidating existing coping skills in the context of loss; (3) group support in the context of loss and society that stigmatizes difference; and (4) the dualism of experience between Parkinson's and mindful meditation. Conclusions: This study has indicated that MBCT could benefit people with PD and was an acceptable form of group intervention