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The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

Chronic obstructive pulmonary disease (COPD) is defined as airflow limitation that is not fully reversible, usually progressive and associated with an abnormal inflammatory response to noxious particles or gases. By the time COPD has progressed to the point of clinical symptoms, over half of lung function may have been lost. This review will first describe studies that have examined the feasibility and yield of early detection of COPD using spirometry as a gold standard. Next, we will review existing studies that have examined the effects of pharmacotherapy on early (mild-to-moderate) COPD, specifically focusing on studies that have attempted to alter the natural history of disease. Finally, we will briefly discuss studies that have tested the effects of various pharmacologic interventions on biomarkers felt to be relevant to disease pathogenesis. Discovery of effective pharmacotherapy that can prevent disease progression in early-stage COPD has enormous public-health implications, given the current global burden of disease and the proportion of individuals at risk - aging current and former smokers.

Objective To determine the feasibility of distractive auditory stimuli (DAS) used during an upper extremity training (UET) program on perceived dyspnea, functional performance, and health-related quality of life. In addition, to determine the appropriate music tempo used during the UET. Design Experimental, randomized, 3-group design with testing at baseline and 4 weeks. Setting Outpatient. Patients Thirty patients (13 male and 17 female) with moderate to severe chronic obstructive pulmonary disease (FEV1 41.27% +/- 18% predicted). Intervention Moderate DAS group (n = 10) and slow DAS group (n = 10) subjects were instructed to perform UET for up to 15 minutes 3 to 5 times a week using DAS (walkman, audiocassettes). The control group (n = 10) received the same instructions, but no DAS. Measures and results Primary outcome measures were perceived dyspnea, functional performance using the 6-minute peg and ring board (6MRPB) count and health-related quality of life. In addition, all subjects recorded the time of UET performance using self-report (daily logs). A significant increase was seen in 6MRPB count (P = .002) between groups. Moderate DAS subjects increased 6MPRB count 46 +/- 21 rings and slow DAS subjects increased 46 +/- 20 rings from baseline to 4 weeks whereas control subjects increased only 5 +/- 4 rings. No significant differences were noted for the remaining variables. Conclusion Subjects who used DAS (music) while performing UET improved functional performance whereas controls failed to continue improvement. The DAS is a feasible adjunct to UET that may have the potential to augment the effectiveness of pulmonary rehabilitation training.