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Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico
ClinicalTrials.gov Identifier:
NCT01481727
First received: October 20, 2011
Last updated: May 22, 2015
Last verified: May 2015
  Purpose
The purpose of this study is to evaluate the efficacy of high-intensity non invasive mechanical ventilation (during one year to reduce the severity and frequency of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in patients with frequent AECOPD (frequent exacerbations defined more two or more AECOPD) and in GOLD IV stage (very severe COPD). The design is a randomised, double blind and controled with placebo (sham maneuver) clinical trial.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Device: BiPAP Pro 2, Phillips Respironics Device: CPAP sham Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Exacerbation's Prevention in Patients With COPD in GOLD IV Stage (Very Severe) With Non Invasive Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico:

Primary Outcome Measures:
  • acute exacerbations of Chronic Obstructive Pulmonary Disease frequency [ Time Frame: 1 year ]
    It will be calculated the exacerbation/year-patien rate and will be compared between groups

  • acute exacerbation of chronic obstructive pulmonary disease severity [ Time Frame: 1 year ]
    It will be measured the rate of AECOPD with hospitalary and Intensive Care Unity requirement


Secondary Outcome Measures:
  • lymphocyte subpopulations Th-1 and Th-17 [ Time Frame: 1 year ]
    It will be measured the lymphocyte subpopulations like Th-1 and Th-17

  • six-minute walking test [ Time Frame: 1 year ]
  • Forced expiratory volume in first second (FEV1) and forced expiratory capacity [ Time Frame: 1 year ]
  • Maximal inspiratory pressure and maximal expiratory pressure [ Time Frame: 1 año ]
  • gas exchange response (carbon and oxygen dioxide arterial pressure) [ Time Frame: 1 year ]
  • Health related quality of life [ Time Frame: one year ]
  • anxiety and depression measures (HAD and Beck Questionnaires) [ Time Frame: one year ]
  • echocardiographic parameters [ Time Frame: one year ]
  • survival [ Time Frame: one year ]
  • IL-1 and IL-6 cytokines [ Time Frame: one year ]
    it will be measured the level of interleukines 1 and 6(IL-1 and IL-6)


Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: cpap sham
non invasive mechanical ventilation type cpap sham manoeuver
Device: BiPAP Pro 2, Phillips Respironics
mechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation.
Other Names:
  • high intensity non invasive ventilation
  • high intensity bilevel
Device: CPAP sham
CPAP sham maneuver (IPAP less or equal to 4cmH2O)
Other Names:
  • placebo CPAP
  • sham non invasive ventilation
Active Comparator: high-intensity NIMV
Non-invasive mechanical ventilation, biPAP modality, with high-intensity IPAP (>18cmH2O)
Device: BiPAP Pro 2, Phillips Respironics
mechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation.
Other Names:
  • high intensity non invasive ventilation
  • high intensity bilevel

Detailed Description:

Background:

  • There are many previous studies (no controlled trials or observational studies)that demonstrated minimal benefits (on gas exchange and marginal effect over exacerbations frequency) with the use of non invasive mechanical ventilation, in BiPAP modality with IPAP pressures <18H2ocm (low intensity), in COPD patients.
  • In subsequent years there were controled trials that concluded that there was no benefits with the use of non invasive mechanical ventilation on BiPAP mode in COPD patients ( It should be mentioned that in most trials were used low inspiratory pressure levels, that is called low-intensity non invasive mechanical ventilation).
  • However, there are other recent studies that described some benefits of high intensity Bilevel modality of non invasive mechanical ventilation (inspiratory pressures >18cmH2O) specially on gas exchange, quality of life and functional status.
  • There are some issues that do not yet have a clear answer like the optimal inspiratory pressure (IPAP) or the ventilation modality (BIPAP or other) to obtain the maximal benefit on COPD patients. Additionally, is not clear also if the use of non invasive mechanical ventilation on COPD patients helps to reduce the frequency and severity of acute exacerbations of COPD (AECOPD).

This study have some characteristics that are different to the previous reports:

  • The inclusion of patients with frequent exacerbations phenotype (and therefore worst prognosis patients)that there are no included in previous trials
  • The intervention maneuver that is bilevel modality of non invasive mechanical ventilation at hig-intensity pressure (>18H2Ocm and <24H2Ocm)
  • The use of placebo maneuver (CPAP "Sham")
  • The home titration in three phases, over a week
  • The long-term use of the intervention and sham maneuver
  Eligibility

Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical and spirometric diagnosis for COPD (FEV1/FVC <70%)
  • Clinical phenotype of frequent exacerbations
  • Must sign the informed consent
  • Former smokers
  • Stable COPD
  • FEV1 <35%
  • Optimal medical treatment

Exclusion Criteria:

  • OSAS diagnosis
  • Other indications for non invasive mechanical ventilation
  • Arterial pressure for dioxide carbon >45mmHg
  • Lung cancer
  • Impossibility for doing spirometry or going to the medical visits
  • Be included in another study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481727

Locations
Mexico
National Institute of Respiratory Diseases
Mexico City, Mexico, 14080
Sponsors and Collaborators
National Institute of Respiratory Diseases, Mexico
Investigators
Principal Investigator: RAUL HUMBERTO SANSORES MARTINEZ, MMS and MD NATIONAL INSTITUTE OF RESPIRATORY DISEASES
  More Information

Publications:

Responsible Party: Alejandra Ramirez Venegas, Head of COPD Clinic, National Institute of Respiratory Diseases, Mexico
ClinicalTrials.gov Identifier: NCT01481727     History of Changes
Other Study ID Numbers: C-18-10NIRD
Study First Received: October 20, 2011
Last Updated: May 22, 2015

Keywords provided by Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico:
acute exacerbation of COPD number
acute exacerbation of COPD severity

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 21, 2017