Chronic Obstructive Pulmonary DiseasePhase 4NCT01481727
Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation
A Phase 4 study testing BiPAP Pro 2, Phillips Respironics in people with Chronic Obstructive Pulmonary Disease, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- BiPAP Pro 2, Phillips Respironics
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2011to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institute of Respiratory Diseases
Mexico City, Mexico City, 14080
About this study
Official title: Exacerbation's Prevention in Patients With COPD in GOLD IV Stage (Very Severe) With Non Invasive Mechanical Ventilation
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.
Read the 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BiPAP Pro 2, Phillips Respironics, CPAP sham
- Keywords
- acute exacerbation of COPD number, acute exacerbation of COPD severity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiPAP Pro 2, Phillips RespironicsDevice
Also called high intensity non invasive ventilation, high intensity bilevel
mechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation.
CPAP shamDevice
Also called placebo CPAP, sham non invasive ventilation
CPAP sham maneuver (IPAP less or equal to 4cmH2O)
| Study group | Role | What they receive |
|---|---|---|
| cpap sham | Placebo comparator | non invasive mechanical ventilation type cpap sham manoeuver Receives: Device: BiPAP Pro 2, Phillips Respironics; Device: CPAP sham |
| high-intensity NIMV | Active comparator | Non-invasive mechanical ventilation, biPAP modality, with high-intensity IPAP (>18cmH2O) Receives: Device: BiPAP Pro 2, Phillips Respironics |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute exacerbations of Chronic Obstructive Pulmonary Disease frequency
It will be calculated the exacerbation/year-patien rate and will be compared between groups
Measured: 1 year
acute exacerbation of chronic obstructive pulmonary disease severity
It will be measured the rate of AECOPD with hospitalary and Intensive Care Unity requirement
Measured: 1 year
Secondary outcomes (10)
lymphocyte subpopulations Th-1 and Th-17
It will be measured the lymphocyte subpopulations like Th-1 and Th-17
Measured: 1 year
six-minute walking test
Measured: 1 year
Forced expiratory volume in first second (FEV1) and forced expiratory capacity
Measured: 1 year
Maximal inspiratory pressure and maximal expiratory pressure
Measured: 1 año
gas exchange response (carbon and oxygen dioxide arterial pressure)
Measured: 1 year
Health related quality of life
Measured: one year
anxiety and depression measures (HAD and Beck Questionnaires)
Measured: one year
echocardiographic parameters
Measured: one year
survival
Measured: one year
IL-1 and IL-6 cytokines
it will be measured the level of interleukines 1 and 6(IL-1 and IL-6)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2015
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico
- Investigators
- RAUL HUMBERTO SANSORES MARTINEZ, MMS and MD, Principal investigator, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481727
- Sponsor's protocol ID
- C-18-10NIRD
- Status last verified
- May 2015
- First submitted
- 20 Oct 2011
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR; Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group. Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial. Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12.
PubMed 19213769Clini E, Sturani C, Rossi A, Viaggi S, Corrado A, Donner CF, Ambrosino N; Rehabilitation and Chronic Care Study Group, Italian Association of Hospital Pulmonologists (AIPO). The Italian multicentre study on noninvasive ventilation in chronic obstructive pulmonary disease patients. Eur Respir J. 2002 Sep;20(3):529-38. doi: 10.1183/09031936.02.02162001.
PubMed 12358325Casanova C, Celli BR, Tost L, Soriano E, Abreu J, Velasco V, Santolaria F. Long-term controlled trial of nocturnal nasal positive pressure ventilation in patients with severe COPD. Chest. 2000 Dec;118(6):1582-90. doi: 10.1378/chest.118.6.1582.
PubMed 11115443Lin CC. Comparison between nocturnal nasal positive pressure ventilation combined with oxygen therapy and oxygen monotherapy in patients with severe COPD. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):353-8. doi: 10.1164/ajrccm.154.2.8756806.
PubMed 8756806Windisch W, Haenel M, Storre JH, Dreher M. High-intensity non-invasive positive pressure ventilation for stable hypercapnic COPD. Int J Med Sci. 2009;6(2):72-6. doi: 10.7150/ijms.6.72. Epub 2009 Feb 27.
PubMed 19277252Dreher M, Storre JH, Schmoor C, Windisch W. High-intensity versus low-intensity non-invasive ventilation in patients with stable hypercapnic COPD: a randomised crossover trial. Thorax. 2010 Apr;65(4):303-8. doi: 10.1136/thx.2009.124263.
PubMed 20388753Windisch W, Kostic S, Dreher M, Virchow JC Jr, Sorichter S. Outcome of patients with stable COPD receiving controlled noninvasive positive pressure ventilation aimed at a maximal reduction of Pa(CO2). Chest. 2005 Aug;128(2):657-62. doi: 10.1378/chest.128.2.657.
PubMed 16100151Budweiser S, Hitzl AP, Jorres RA, Heinemann F, Arzt M, Schroll S, Pfeifer M. Impact of noninvasive home ventilation on long-term survival in chronic hypercapnic COPD: a prospective observational study. Int J Clin Pract. 2007 Sep;61(9):1516-22. doi: 10.1111/j.1742-1241.2007.01427.x.
PubMed 17686094
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exacerbation's Prevention in Patients With COPD in GOLD IV Stage (Very Severe) With Non Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01481727
- Acronym / sponsor ID
- C-18-10NIRD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- acute exacerbation of COPD number, acute exacerbation of COPD severity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- Dec 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cpap sham | Placebo comparator | Device: BiPAP Pro 2, Phillips Respironics, Device: CPAP shamnon invasive mechanical ventilation type cpap sham manoeuver |
| high-intensity NIMV | Active comparator | Device: BiPAP Pro 2, Phillips RespironicsNon-invasive mechanical ventilation, biPAP modality, with high-intensity IPAP (>18cmH2O) |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical and spirometric diagnosis for COPD (FEV1/FVC <70%)
- Clinical phenotype of frequent exacerbations
- Must sign the informed consent
- Former smokers
- Stable COPD
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiPAP Pro 2, Phillips RespironicsAlso: high intensity non invasive ventilation, high intensity bilevelmechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation. | Device | cpap sham, high-intensity NIMV |
| CPAP shamAlso: placebo CPAP, sham non invasive ventilationCPAP sham maneuver (IPAP less or equal to 4cmH2O) | Device | cpap sham |
Primary outcome
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
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
- Background: PubMed 19213769McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR; Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group. Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial. Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12.
- Background: PubMed 12358325Clini E, Sturani C, Rossi A, Viaggi S, Corrado A, Donner CF, Ambrosino N; Rehabilitation and Chronic Care Study Group, Italian Association of Hospital Pulmonologists (AIPO). The Italian multicentre study on noninvasive ventilation in chronic obstructive pulmonary disease patients. Eur Respir J. 2002 Sep;20(3):529-38. doi: 10.1183/09031936.02.02162001.
- Background: PubMed 11115443Casanova C, Celli BR, Tost L, Soriano E, Abreu J, Velasco V, Santolaria F. Long-term controlled trial of nocturnal nasal positive pressure ventilation in patients with severe COPD. Chest. 2000 Dec;118(6):1582-90. doi: 10.1378/chest.118.6.1582.
- Background: PubMed 8756806Lin CC. Comparison between nocturnal nasal positive pressure ventilation combined with oxygen therapy and oxygen monotherapy in patients with severe COPD. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):353-8. doi: 10.1164/ajrccm.154.2.8756806.
- Background: PubMed 19277252Windisch W, Haenel M, Storre JH, Dreher M. High-intensity non-invasive positive pressure ventilation for stable hypercapnic COPD. Int J Med Sci. 2009;6(2):72-6. doi: 10.7150/ijms.6.72. Epub 2009 Feb 27.
- Background: PubMed 20388753Dreher M, Storre JH, Schmoor C, Windisch W. High-intensity versus low-intensity non-invasive ventilation in patients with stable hypercapnic COPD: a randomised crossover trial. Thorax. 2010 Apr;65(4):303-8. doi: 10.1136/thx.2009.124263.
- Background: PubMed 16100151Windisch W, Kostic S, Dreher M, Virchow JC Jr, Sorichter S. Outcome of patients with stable COPD receiving controlled noninvasive positive pressure ventilation aimed at a maximal reduction of Pa(CO2). Chest. 2005 Aug;128(2):657-62. doi: 10.1378/chest.128.2.657.
- Background: PubMed 17686094Budweiser S, Hitzl AP, Jorres RA, Heinemann F, Arzt M, Schroll S, Pfeifer M. Impact of noninvasive home ventilation on long-term survival in chronic hypercapnic COPD: a prospective observational study. Int J Clin Pract. 2007 Sep;61(9):1516-22. doi: 10.1111/j.1742-1241.2007.01427.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAUL HUMBERTO SANSORES MARTINEZ, MMS and MD principal investigator
Instituto Nacional de Enfermedades Respiratorias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BiPAP Pro 2, Phillips Respironics in people with Chronic Obstructive Pulmonary Disease, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute exacerbations of Chronic Obstructive Pulmonary Disease frequency (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481727, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.