Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
921019
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Respiratory diseases
Intervention
Patients will then be randomized into two groups receiving:
1. Non-invasive positive pressure ventilation (NPPV) plus LTOT, or
2. LTOT plus oral placebo over a 3-month period.
NPPV will be delivered via a portable bilevel positive airway pressure (BiPAP) Duet device via a nasal or oral-nasal mask.
Intervention type
Drug
Phase
Not Specified
Drug names
oxygen
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with severe stable chronic obstructive pulmonary disease with hypercapnic respiratory failure already on domiciliary long-term oxygen therapy (LTOT)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2002
Recruitment end date
31/12/2002
Locations
Countries of recruitment
China
Trial participating centre
Department of Medicine & Therapeutics
-
-
Hong Kong
Sponsor information
Organisation
Hong Kong Health Services Research Fund (Hong Kong)
Sponsor details
Health Welfare and Food Bureau
Government Secretariat
HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong
+852 (0)2973 8288
hsrf@hwfb.gov.hk
Sponsor type
Government
Website
http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html
Funders
Funder type
Government
Funder name
Hong Kong Health Services Research Fund (Hong Kong)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary