NCT02499718

Brief Summary

Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
368

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

2.9 years

First QC Date

June 9, 2015

Last Update Submit

July 15, 2015

Conditions

Chronic Obstructive Pulmonary DiseaseHypercapnic Respiratory Failure

Keywords

Chronic Obstructive Pulmonary DiseaseNon-invasive positive pressure ventilationquality of lifelong-term oxygen therapy

Outcome Measures

Primary Outcomes (1)

  • Severe Respiratory Insufficiency (SRI) Questionnaire

    1 year

Secondary Outcomes (10)

  • Blood gas analysis

    1 year

  • Pulmanory function

    1 year

  • Baseline Dyspnea Index/Transition Dyspnea Index

    1 year

  • Chromic Respiratory Questionnaire

    1 year

  • Chronic Obstructive Pulmonary Disease (COPD) Assessment Test

    1 year

  • +5 more secondary outcomes

Study Arms (2)

Noninvasive ventilator

EXPERIMENTAL

noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease

Device: BiPAP mode

LTOT

NO INTERVENTION

long-term oxygen therapy for severe stable chronic obstructive pulmonary disease

Interventions

BiPAP modeDEVICE

Noninvasive ventilator

Noninvasive ventilator

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically stable, hypercapnic GOLD stage IV COPD, aged 18 years or older, baseline arterial carbon dioxide pressure (PaCO2) of 6.7 kPa (50 mmHg) or higher and a pH higher than 7·35, measured after at least 1 h rest in a sitting position.

You may not qualify if:

  • thorax or the lung other than COPD
  • No smoking or Cigarette≤10/day
  • obesity with a bodymass index (BMI) ≥40 kg/m²
  • malignant co-morbidities,severe heart failure (New York Heart Association stage IV),unstable angina, and severe arrhythmias.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (2)

  • Chen R, Guan L, Wu W, Yang Z, Li X, Luo Q, Liang Z, Wang F, Guo B, Huo Y, Yang Y, Zhou L. The Chinese version of the Severe Respiratory Insufficiency questionnaire for patients with chronic hypercapnic chronic obstructive pulmonary disease receiving non-invasive positive pressure ventilation. BMJ Open. 2017 Aug 28;7(8):e017712. doi: 10.1136/bmjopen-2017-017712.

    PMID: 28851800DERIVED

  • Zhou L, Li X, Guan L, Chen J, Guo B, Wu W, Huo Y, Zhou Z, Liang Z, Zhou Y, Tan J, Chen X, Song Y, Chen R. Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial. Int J Chron Obstruct Pulmon Dis. 2017 Apr 27;12:1279-1286. doi: 10.2147/COPD.S127540. eCollection 2017.

    PMID: 28490871DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Central Study Contacts

Zhou LuQian, Doctor

CONTACT

+86-15622236759zhlx09@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Guangzhou Institute of Respiratory Disease

Study Record Dates

First Submitted

June 9, 2015

First Posted

July 16, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

CN(1)