Home | All trials

[RDF data]
Trial NCT00000565

Resource URI: http://static.linkedct.org/resource/trials/NCT00000565
PropertyValue
linkedct:brief_title Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
linkedct:condition <http://static.linkedct.org/resource/condition/2817>
linkedct:condition <http://static.linkedct.org/resource/condition/7483>
linkedct:condition <http://static.linkedct.org/resource/condition/7486>
linkedct:criteria Men and women, ages 30 to 74, who were ambulatory and had symptomatic chronic bronchitis or emphysema.
linkedct:description BACKGROUND: Intermittent positive pressure breathing may be a useful adjunct therapy for patients with chronic obstructive pulmonary disease. It is, however, quite expensive; moreover, in 1976 its treatment efficacy had not been determined. Although the effectiveness of IPPB had been previously studied, the influence of long-term treatment was not known for the following reasons: The individuals studied had been too few and were not randomly assigned to treatment groups, the patient groups were not homogeneous and their clinical and functional status were not well-documented, and precise descriptions of the manner in which IPPB was administered were not recorded. Based on these facts, a conference on the Scientific Basis of Respiratory Therapy, co-sponsored by the American Thoracic Society and the Division of Lung Diseases, issued a recommendation to develop a controlled clinical study of IPPB. Contracts were awarded to five clinical centers and a data center in November 1976. Planning of the trial ended in November 1977. Recruitment began in April 1978 for the 985 individuals who took part in this trial and ended in October 1980. Patients enrolled after March 31, 1980, were followed for 30 months instead of 36 months. Follow-up was completed in May 1983. DESIGN NARRATIVE: Randomized, fixed sample of 985 patients. Eligible patients were assigned to a treatment group using intermittent positive pressure breathing or to a control group using a powered nebulizer for treatment 3-4 times a day. Treatments continued for 3 years. Endpoints related to quality of life and respiratory function and capability.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 74 Years
linkedct:eligibility_minimum_age 30 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000565
rdfs:label Trial NCT00000565
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000565
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 203
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/12558>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/16167>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28968>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/43538>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/46035>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/47189>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000565>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/1664>
linkedct:reference <http://static.linkedct.org/resource/reference/2561>
linkedct:reference <http://static.linkedct.org/resource/reference/39514>
linkedct:reference <http://static.linkedct.org/resource/reference/39515>
linkedct:reference <http://static.linkedct.org/resource/reference/41268>
linkedct:reference <http://static.linkedct.org/resource/reference/41965>
linkedct:reference <http://static.linkedct.org/resource/reference/41966>
linkedct:reference <http://static.linkedct.org/resource/reference/43310>
linkedct:reference <http://static.linkedct.org/resource/reference/43358>
linkedct:reference <http://static.linkedct.org/resource/reference/43774>
linkedct:reference <http://static.linkedct.org/resource/reference/43948>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date November 1976
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary To evaluate the efficacy of long-term intermittent positive pressure breathing (IPPB) treatment when used as an adjunct to the overall care of ambulatory outpatients with chronic obstructive pulmonary disease. The evaluation compared the use of IPPB with use of a powered nebulizer.
rdf:type linkedct:trials
linkedct:verification_date May 2002