The long-term oxygen treatment trial for chronic obstructive pulmonary disease: Rationale, design, and lessons learned

for the LOTT Research Group

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)89-101
Number of pages13
JournalAnnals of the American Thoracic Society
Volume15
Issue number1
DOIs
StatePublished - Jan 2018

Keywords

  • Chronic obstructive pulmonary disease
  • Hypoxemia
  • Oxygen
  • Randomized controlled trial
  • Survival

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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