Asthma AcuteNCT03154762
Anti-inflammatory Effect of Nocturnal NIPPV on Acute Asthma
A study testing NIPPV and CPAP in people with Asthma Acute, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
Trial summary
INTRODUCTION: Asthma is a disease characterized by inflammation of the airway and secondary contraction of smooth muscle. Treatment for the crisis consist in the use of local and / or systemic bronchodilators and anti-inflammatories, and it has been shown that mechanical ventilation to the airway through non-invasive… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma Acute
- What is being tested?
- NIPPV and CPAP
- 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
- 1 Jun 2017to 31 Oct 2017
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of asthma, performed by a physician, with spirometry and stable treatment for at least 3 previous months.
- Severe asthma crisis and hospitalization requirement of at least 4 days.
Who cannot join
- Life-threatening crisis.
- Requirement of Invasive or Non-Invasive Mechanical Ventilation.
- High risk for Obstructive Sleep Apnea (measured through the Berlin questionnaire).
- Active smoking.
- Another chronic lung disease other than asthma.
- Pneumonia (defined by the presence of an opacity of the lung parenchyma on a chest x-ray).
- Ischemic heart disease.
- Uncontrolled systemic arterial hypertension.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Enfermedades Respiratorias
Mexico City, 14080
About this study
Official title: National Institute of Respiratory Diseases Mexico
INTRODUCTION: Asthma is a disease characterized by inflammation of the airway and secondary contraction of smooth muscle. Treatment for the crisis consist in the use of local and / or systemic bronchodilators and anti-inflammatories, and it has been shown that mechanical ventilation to the airway through non-invasive positive pressure ventilation (NIPPV) decreases bronchial hyperreactivity and contractility of smooth muscle.
OBJECTIVES: To assess the effect of nocturnal NIPPV on local inflammation, systemic inflammation and the state of hypersensitivity in patients with asthma attack.
MATERIALS AND METHODS: We will include patients with severe asthma attacks requiring hospitalization, without indication for acute NIPPV, and will be randomized to receive NIPPV with an spontaneous (S) bilevel or continuous positive airway pressure (CPAP, control group), all patients will receive standard treatment; gasometric exchange, local inflammation (FEV1 and Exhaled fraction of nitric oxide), systemic inflammation (C reactive protein, IL-4, IL-5, IL-13 and IL-17 in peripheral blood) and the hypersensitivity state (eosinophilia and IgE) between both groups will be compared after 4 days of treatment.
Read the detailed description
RESEARCH QUESTION What is the effect of non invasive positive pressure ventilation (NIPPV) on systemic inflammation in patients with asthma attacks?
JUSTIFICATION Asthma is a global public health problem and one of the primary causes of care at the National Institute of Respiratory Diseases in Mexico; when presented as a crisis is a serious condition that puts the life of the patient at risk; in vitro and in vivo studies have shown that the application of chronic airway distention using non-invasive mechanical ventilation produces a reduction in bronchial hyperreactivity in patients with asthma and may have a positive effect on the treatment of this condition independent of its effects on ventilation in the presence of acute respiratory failure.
HYPOTHESIS The use of NIPPV will improve systemic inflammation assessed by C reactive protein (CRP) in patients with severe asthmatic crisis.
OBJECTIVES
Main Objective:
To assess the effect of NIPPV on systemic inflammation measure through C reactive protein in acute asthma
Secondary objectives:
- - To assess the effect of NIPPV on the days of hospital stay in patients with asthma attacks.
- - To evaluate adherence to NIPPV in patients with asthma attacks.
- - To evaluate the effect of NIPPV on PaO2, PaCO2 and SpO2 in patients with asthma attacks.
- - To evaluate the effect of NIPPV on FEV1 and Exhaled fraction of nitric oxide in patients with asthma attacks.
- - To evaluate the effect of NIPPV on serum levels of interleukin (IL)-4, IL-5, IL-13 and IL-17 in patients with asthma attacks.
- - To assess the effect of NIPPV on total eosinophil count and Immunoglobulin (Ig) E level in patients with asthma attacks.
MATERIALS AND METHODS
- Design: A prospective, longitudinal, comparative, parallel group study will be conducted; it was approved by the Science and Bioethics Committees of the National Institute of Respiratory Diseases Mexico with the code C34-14. In all cases, informed consent will be requested.
- Place: It will be carried out in the emergency and hospitalization service of the National Institute of Respiratory Diseases "Ismael Cosío Villegas" at Mexico city.
- - Procedures:
- Clinical history.
- Chest X-ray.
- Berlin Questionnaire. The Berlin questionnaire is a self-administered questionnaire validated in Spanish to establish the risk of obstructive sleep apnea.
- Arterial gasometry.
- Blood cell count.
- Ultrasensitive C-reactive protein.
- Determination of IgE.
- Spirometry and Exhaled fraction of nitric oxide according to international guidelines.
- - Intervention: Patients included will be randomized to receive, 4 nights of noninvasive nocturnal positive pressure ventilation with an S Bilevel device with a 12 cmH2O inspiratory pressure and a 4 cmH2O expiratory pressure or a 4 cmH2O Continuous Positive Airway Pressure (CPAP), as a control group. The equipment will be placed at night ad libitum and retired the following day in the morning, in all cases a VPAP ST S8 RESMED will be used. If the patient needs to increase inspired oxygen fraction it will be performed with nasal tips during the day and a distal oxygen connector at night. In all cases a nasal mask will be used. Blood gasometry, blood cell count, CRP, serum IL-4, IL-5, IL-13, IL-17 and IgE, Spirometry and Exhaled fraction of nitric oxide will be repeated at day 4.
- - Data Analysis A convenience sample of 20 patients was established. A balanced randomization will be performed. The variables were summarized according to their type and distribution. The comparison of dichotomous variables will be performed using Fisher's Exact test. The comparison of independent continuous variables will be carried out with U of Mann Whitney and the related variables will be analyzed with Wilcoxon Related Ranks Test.
- Conditions
- Asthma Acute
- Being tested
- NIPPV, CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPPVDevice
Also called bilevel
Application of chronic distension of the airway through NIPPV to produce a reduction in bronchial hyperreactivity.
CPAPDevice
4 cmH2O CPAP as the minimum pressure necessary to mobilize the air flow and avoid the space death with no effect on the ventilation.
| Study group | Role | What they receive |
|---|---|---|
| NIPPV | Experimental | Patients will receive NIPPV with an S bilevel device during 4 nights, the equipment will be placed ad libitum, a 12 cmH2O inspiratory pressure and a 4 cmH2O expiratory pressure will be administered through a nasal mask. CRP, FEV1, exhaled fraction of nitric oxide, IL-4, IL-5, IL-13, IL-17, IgE, cell count will be measured before and after intervention. Receives: Device: NIPPV |
| CPAP | Sham comparator | Patients will receive a 4 cmH2O continuous positive airway pressure device during 4 nights; this is the minimum pressure necessary to avoid death space with no effect on minute ventilation. The equipment will be placed ad libitum. Pressure will be administered through a nasal mask. CRP, FEV1, exhaled fraction of nitric oxide, IL-4, IL-5, IL-13, IL-17, IgE, cell count will be measured before and after sham intervention. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Inflammation
To evaluate the effect of NIPPV on C reactive protein in patients with asthma attacks.
Measured: 4 days
Secondary outcomes (5)
Hospitalization
To evaluate the effect of NIPPV on the days of hospital stay in patients with asthma attacks.
Measured: 4 days
Adherence
To evaluate adherence to NIPPV in patients with asthma attacks
Measured: 4 days
Gas Exchange
To evaluate the effect of NIPPV on PaCO2, PaO2 and SaO2 in patients with asthma attacks.
Measured: 4 days
Local Inflammation
To evaluate the effect of NIPPV on FEV1 and exhaled fraction of nitric oxide in patients with asthma attacks.
Measured: 4 days
Serum Inflammation
To evaluate the effect of NIPPV on serum IL-4, IL-5, IL-13 e IL-17 in patients with asthma.attacks.
Measured: 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jun 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Asthma AcuteStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, prospective, longitudinal, comparative, parallel group study
- 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, Jose Luis Carrillo Alduenda, National Institute of Respiratory Diseases, Mexico
- Investigators
- Jose Luis Carrillo Alduenda, Principal investigator, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154762
- Sponsor's protocol ID
- C34-14
- Status last verified
- Aug 2019
- First submitted
- 11 May 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Through this organization and will be provided at the individual request of each interested researcher.
Publications
Lafond C, Series F, Lemiere C. Impact of CPAP on asthmatic patients with obstructive sleep apnoea. Eur Respir J. 2007 Feb;29(2):307-11. doi: 10.1183/09031936.00059706. Epub 2006 Oct 18.
PubMed 17050561Xue Z, Yu Y, Gao H, Gunst SJ, Tepper RS. Chronic continuous positive airway pressure (CPAP) reduces airway reactivity in vivo in an allergen-induced rabbit model of asthma. J Appl Physiol (1985). 2011 Aug;111(2):353-7. doi: 10.1152/japplphysiol.01345.2010. Epub 2011 Apr 14.
PubMed 21493723Salerno FG, Pellegrino R, Trocchio G, Spanevello A, Brusasco V, Crimi E. Attenuation of induced bronchoconstriction in healthy subjects: effects of breathing depth. J Appl Physiol (1985). 2005 Mar;98(3):817-21. doi: 10.1152/japplphysiol.00763.2004. Epub 2004 Oct 8.
PubMed 15475599
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Institute of Respiratory Diseases Mexico
- ClinicalTrials.gov ID
- NCT03154762
- Acronym / sponsor ID
- C34-14
- Conditions
- Asthma Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 16 May 2017 (actual)
- 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.
INTRODUCTION: Asthma is a disease characterized by inflammation of the airway and secondary contraction of smooth muscle. Treatment for the crisis consist in the use of local and / or systemic bronchodilators and anti-inflammatories, and it has been shown that mechanical ventilation to the airway through non-invasive positive pressure ventilation (NIPPV) decreases bronchial hyperreactivity and contractility of smooth muscle.
OBJECTIVES: To assess the effect of nocturnal NIPPV on local inflammation, systemic inflammation and the state of hypersensitivity in patients with asthma attack.
MATERIALS AND METHODS: We will include patients with severe asthma attacks requiring hospitalization, without indication for acute NIPPV, and will be randomized to receive NIPPV with an spontaneous (S) bilevel or continuous positive airway pressure (CPAP, control group), all patients will receive standard treatment; gasometric exchange, local inflammation (FEV1 and Exhaled fraction of nitric oxide), systemic inflammation (C reactive protein, IL-4, IL-5, IL-13 and IL-17 in peripheral blood) and the hypersensitivity state (eosinophilia and IgE) between both groups will be compared after 4 days of treatment.
Detailed description
RESEARCH QUESTION What is the effect of non invasive positive pressure ventilation (NIPPV) on systemic inflammation in patients with asthma attacks?
JUSTIFICATION Asthma is a global public health problem and one of the primary causes of care at the National Institute of Respiratory Diseases in Mexico; when presented as a crisis is a serious condition that puts the life of the patient at risk; in vitro and in vivo studies have shown that the application of chronic airway distention using non-invasive mechanical ventilation produces a reduction in bronchial hyperreactivity in patients with asthma and may have a positive effect on the treatment of this condition independent of its effects on ventilation in the presence of acute respiratory failure.
HYPOTHESIS The use of NIPPV will improve systemic inflammation assessed by C reactive protein (CRP) in patients with severe asthmatic crisis.
OBJECTIVES
Main Objective:
To assess the effect of NIPPV on systemic inflammation measure through C reactive protein in acute asthma
Secondary objectives:
- - To assess the effect of NIPPV on the days of hospital stay in patients with asthma attacks.
- - To evaluate adherence to NIPPV in patients with asthma attacks.
- - To evaluate the effect of NIPPV on PaO2, PaCO2 and SpO2 in patients with asthma attacks.
- - To evaluate the effect of NIPPV on FEV1 and Exhaled fraction of nitric oxide in patients with asthma attacks.
- - To evaluate the effect of NIPPV on serum levels of interleukin (IL)-4, IL-5, IL-13 and IL-17 in patients with asthma attacks.
- - To assess the effect of NIPPV on total eosinophil count and Immunoglobulin (Ig) E level in patients with asthma attacks.
MATERIALS AND METHODS
- Design: A prospective, longitudinal, comparative, parallel group study will be conducted; it was approved by the Science and Bioethics Committees of the National Institute of Respiratory Diseases Mexico with the code C34-14. In all cases, informed consent will be requested.
- Place: It will be carried out in the emergency and hospitalization service of the National Institute of Respiratory Diseases "Ismael Cosío Villegas" at Mexico city.
- - Procedures:
- Clinical history.
- Chest X-ray.
- Berlin Questionnaire. The Berlin questionnaire is a self-administered questionnaire validated in Spanish to establish the risk of obstructive sleep apnea.
- Arterial gasometry.
- Blood cell count.
- Ultrasensitive C-reactive protein.
- Determination of IgE.
- Spirometry and Exhaled fraction of nitric oxide according to international guidelines.
- - Intervention: Patients included will be randomized to receive, 4 nights of noninvasive nocturnal positive pressure ventilation with an S Bilevel device with a 12 cmH2O inspiratory pressure and a 4 cmH2O expiratory pressure or a 4 cmH2O Continuous Positive Airway Pressure (CPAP), as a control group. The equipment will be placed at night ad libitum and retired the following day in the morning, in all cases a VPAP ST S8 RESMED will be used. If the patient needs to increase inspired oxygen fraction it will be performed with nasal tips during the day and a distal oxygen connector at night. In all cases a nasal mask will be used. Blood gasometry, blood cell count, CRP, serum IL-4, IL-5, IL-13, IL-17 and IgE, Spirometry and Exhaled fraction of nitric oxide will be repeated at day 4.
- - Data Analysis A convenience sample of 20 patients was established. A balanced randomization will be performed. The variables were summarized according to their type and distribution. The comparison of dichotomous variables will be performed using Fisher's Exact test. The comparison of independent continuous variables will be carried out with U of Mann Whitney and the related variables will be analyzed with Wilcoxon Related Ranks Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Experimental, prospective, longitudinal, comparative, parallel group study
| Arm | Type | Receives |
|---|---|---|
| NIPPV | Experimental | Device: NIPPVPatients will receive NIPPV with an S bilevel device during 4 nights, the equipment will be placed ad libitum, a 12 cmH2O inspiratory pressure and a 4 cmH2O expiratory pressure will be administered through a nasal mask. CRP, FEV1, exhaled fraction of nitric oxide, IL-4, IL-5, IL-13, IL-17, IgE, cell count will be measured before and after intervention. |
| CPAP | Sham comparator | Device: CPAPPatients will receive a 4 cmH2O continuous positive airway pressure device during 4 nights; this is the minimum pressure necessary to avoid death space with no effect on minute ventilation. The equipment will be placed ad libitum. Pressure will be administered through a nasal mask. CRP, FEV1, exhaled fraction of nitric oxide, IL-4, IL-5, IL-13, IL-17, IgE, cell count will be measured before and after sham intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of asthma, performed by a physician, with spirometry and stable treatment for at least 3 previous months.
- Severe asthma crisis and hospitalization requirement of at least 4 days.
Key exclusion criteria (8 listed)
- Life-threatening crisis.
- Requirement of Invasive or Non-Invasive Mechanical Ventilation.
- High risk for Obstructive Sleep Apnea (measured through the Berlin questionnaire).
- Active smoking.
- Another chronic lung disease other than asthma.
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 |
|---|---|---|
| NIPPVAlso: bilevelApplication of chronic distension of the airway through NIPPV to produce a reduction in bronchial hyperreactivity. | Device | NIPPV |
| CPAP4 cmH2O CPAP as the minimum pressure necessary to mobilize the air flow and avoid the space death with no effect on the ventilation. | Device | CPAP |
Primary outcome
Systemic Inflammation
Time frame: 4 days
To evaluate the effect of NIPPV on C reactive protein in patients with asthma attacks.
5 secondary outcomes
Hospitalization
Time frame: 4 days
Adherence
Time frame: 4 days
Gas Exchange
Time frame: 4 days
Local Inflammation
Time frame: 4 days
Serum Inflammation
Time frame: 4 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Results publication: PubMed 17050561Lafond C, Series F, Lemiere C. Impact of CPAP on asthmatic patients with obstructive sleep apnoea. Eur Respir J. 2007 Feb;29(2):307-11. doi: 10.1183/09031936.00059706. Epub 2006 Oct 18.
- Results publication: PubMed 21493723Xue Z, Yu Y, Gao H, Gunst SJ, Tepper RS. Chronic continuous positive airway pressure (CPAP) reduces airway reactivity in vivo in an allergen-induced rabbit model of asthma. J Appl Physiol (1985). 2011 Aug;111(2):353-7. doi: 10.1152/japplphysiol.01345.2010. Epub 2011 Apr 14.
- Results publication: PubMed 15475599Salerno FG, Pellegrino R, Trocchio G, Spanevello A, Brusasco V, Crimi E. Attenuation of induced bronchoconstriction in healthy subjects: effects of breathing depth. J Appl Physiol (1985). 2005 Mar;98(3):817-21. doi: 10.1152/japplphysiol.00763.2004. Epub 2004 Oct 8.
- Individual participant dataSharing planned: Yes. Through this organization and will be provided at the individual request of each interested researcher.
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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.
Jose Luis Carrillo Alduenda 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 study testing NIPPV and CPAP in people with Asthma Acute, 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 28 Aug 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Systemic Inflammation (time frame: 4 days). 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 NCT03154762, which also lists 3 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 28 Aug 2019.