Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatments bipap pro 2, phillips respironics, cpap sham
Phase phase 4
Sponsor National Institute of Respiratory Diseases, Mexico
Start date December 2011
End date March 2015
Trial size 20 participants
Trial identifier NCT01481727, C-18-10NIRD

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Placebo Comparator)
non invasive mechanical ventilation type cpap sham manoeuver
bipap pro 2, phillips respironics high intensity non invasive ventilation
mechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation.
cpap sham placebo CPAP
CPAP sham maneuver (IPAP less or equal to 4cmH2O)
(Active Comparator)
Non-invasive mechanical ventilation, biPAP modality, with high-intensity IPAP (>18cmH2O)
bipap pro 2, phillips respironics high intensity non invasive ventilation
mechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation.

Primary Outcomes

Measure
acute exacerbations of Chronic Obstructive Pulmonary Disease frequency
time frame: 1 year
acute exacerbation of chronic obstructive pulmonary disease severity
time frame: 1 year

Secondary Outcomes

Measure
lymphocyte subpopulations Th-1 and Th-17
time frame: 1 year
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

Eligibility Criteria

Male or female participants from 45 years up to 85 years old.

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

Additional Information

Official title Exacerbation's Prevention in Patients With COPD in GOLD IV Stage (Very Severe) With Non Invasive Mechanical Ventilation
Principal investigator RAUL HUMBERTO SANSORES MARTINEZ, MMS and MD
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by National Institute of Respiratory Diseases, Mexico.