NCT00000564

Brief Summary

To compare the efficacy of long-term use of nocturnal oxygen therapy (12 hours) with that of continuous, low-flow oxygen therapy (24 hours) in patients with chronic hypoxic lung disease.

Trial Health

100
On Track

Trial Health Score

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Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1976

Completed
23.3 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2002

First QC Date

October 27, 1999

Last Update Submit

June 23, 2005

Conditions

Lung DiseasesLung Diseases, ObstructiveChronic Obstructive Pulmonary Disease

Interventions

oxygen inhalation therapyPROCEDURE

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women, ages 35 to 70, who had severe chronic obstructive lung disease requiring supplemental oxygen therapy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (6)

  • Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.

    PMID: 6776858BACKGROUND

  • Is 12-hour oxygen as effective as 24-hour oxygen in advanced chronic obstructive pulmonary disease with hypoxemia? (The nocturnal oxygen therapy trial--NOTT). Chest. 1980 Sep;78(3):419-20. doi: 10.1378/chest.78.3.419. No abstract available.

    PMID: 7418460BACKGROUND

  • DeMets DL, Williams GW, Brown BW Jr. A case report of data monitoring experience: the nocturnal oxygen therapy trial. Control Clin Trials. 1982 Jun;3(2):113-24. doi: 10.1016/0197-2456(82)90039-3.

    PMID: 6749425BACKGROUND

  • Heaton RK, Grant I, McSweeny AJ, Adams KM, Petty TL. Psychologic effects of continuous and nocturnal oxygen therapy in hypoxemic chronic obstructive pulmonary disease. Arch Intern Med. 1983 Oct;143(10):1941-7.

    PMID: 6625781BACKGROUND

  • Jacques J, Cooney TP, Silvers GW, Petty TL, Wright JL, Thurlbeck WM. The lungs and causes of death in the nocturnal oxygen therapy trial. Chest. 1984 Aug;86(2):230-3. doi: 10.1378/chest.86.2.230.

    PMID: 6378540BACKGROUND

  • Williams GW, Snedecor SM, DeMets DL. Recruitment experience in the Nocturnal Oxygen Therapy Trial. Control Clin Trials. 1987 Dec;8(4 Suppl):121S-130S. doi: 10.1016/0197-2456(87)90015-8.

    PMID: 3440385BACKGROUND

MeSH Terms

Conditions

Lung DiseasesLung Diseases, ObstructivePulmonary Disease, Chronic Obstructive

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Nicholas Anthonisen

    University of Manitoba

  • C.Thomas Boylen

    University of Southern California

  • David Cugell

    Northwestern University

  • Paul Kvale

    Henry Ford Hospital

  • Thomas Petty

    University of Colorado, Denver

  • Richard Timms

    University of California, San Diego

  • George Williams

    The Cleveland Clinic

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

July 1, 1976

Last Updated

June 24, 2005

Record last verified: 2002-05