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Status unknownNCT02499718Updated Jul 16, 2015

Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease

An interventional study of BiPAP mode in Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure, sponsored by Guangzhou Institute of Respiratory Disease. Status unknown at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-16.

Sponsored by Guangzhou Institute of Respiratory Disease · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
368
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Hypercapnic Respiratory Failure

Keywords

  • Chronic Obstructive Pulmonary Disease
  • Non-invasive positive pressure ventilation
  • quality of life
  • long-term oxygen therapy
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 368 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
368 participants (estimated)

Study arms

  • Experimental
    Noninvasive ventilator

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

    Device: BiPAP mode

  • No intervention
    LTOT

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

Interventions

  • DeviceBiPAP mode

    Noninvasive ventilator

06

What researchers measure

Primary outcomes

  1. Severe Respiratory Insufficiency (SRI) Questionnaire

    Time frame: 1 year

Secondary outcomes

  1. Blood gas analysis

    Time frame: 1 year

  2. Pulmanory function

    Time frame: 1 year

  3. Baseline Dyspnea Index/Transition Dyspnea Index

    Time frame: 1 year

  4. Chromic Respiratory Questionnaire

    Time frame: 1 year

  5. Chronic Obstructive Pulmonary Disease (COPD) Assessment Test

    Time frame: 1 year

  6. 6 Minute-Walking Distance and Borg Score

    Time frame: 1 year

  7. The frequency of exacerbation

    Time frame: 1 year

  8. The frequency of readmission

    Time frame: 1 year

  9. The frequency of ICU readmission

    Time frame: 1 year

  10. survival rate

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Guangzhou Institute of Respiratory Disease
    Guangzhou, Guangdong 510120, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 28851800 ↗
  • 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. PubMed 28490871 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02499718
Lead sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Southern Medical University, China, Second Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Dongguan People's Hospital
Responsible party
LuQian Zhou (Assistant Professor of Guangzhou Institute of Respiratory Disease, Guangzhou Institute of Respiratory Disease) — Principal investigator
First posted
Jul 16, 2015
Start date
Jan 2014
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jul 16, 2015

Study contacts

Zhou LuQian, Doctor
Contact
zhlx09@163.com
+86-15622236759

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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