Anti-inflammatory Effect of Nocturnal NIPPV on Acute Asthma

August 22, 2019 updated by: Jose Luis Carrillo Alduenda, National Institute of Respiratory Diseases, Mexico

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. - To assess the effect of NIPPV on the days of hospital stay in patients with asthma attacks.
  2. - To evaluate adherence to NIPPV in patients with asthma attacks.
  3. - To evaluate the effect of NIPPV on PaO2, PaCO2 and SpO2 in patients with asthma attacks.
  4. - To evaluate the effect of NIPPV on FEV1 and Exhaled fraction of nitric oxide in patients with asthma attacks.
  5. - 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.
  6. - To assess the effect of NIPPV on total eosinophil count and Immunoglobulin (Ig) E level in patients with asthma attacks.

MATERIALS AND METHODS

  1. 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.
  2. 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.

  3. - 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.

  4. - 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.

  5. - 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Ciudad de México, Mexico, 14080
        • Instituto Nacional De Enfermedades Respiratorias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NIPPV
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.
Device: NIPPV
Application of chronic distension of the airway through NIPPV to produce a reduction in bronchial hyperreactivity.
Other Names:
  • bilevel
Sham Comparator: CPAP
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.
Device: CPAP
4 cmH2O CPAP as the minimum pressure necessary to mobilize the air flow and avoid the space death with no effect on the ventilation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systemic Inflammation
Time Frame: 4 days
To evaluate the effect of NIPPV on C reactive protein in patients with asthma attacks.
4 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalization
Time Frame: 4 days
To evaluate the effect of NIPPV on the days of hospital stay in patients with asthma attacks.
4 days
Adherence
Time Frame: 4 days
To evaluate adherence to NIPPV in patients with asthma attacks
4 days
Gas Exchange
Time Frame: 4 days
To evaluate the effect of NIPPV on PaCO2, PaO2 and SaO2 in patients with asthma attacks.
4 days
Local Inflammation
Time Frame: 4 days
To evaluate the effect of NIPPV on FEV1 and exhaled fraction of nitric oxide in patients with asthma attacks.
4 days
Serum Inflammation
Time Frame: 4 days.
To evaluate the effect of NIPPV on serum IL-4, IL-5, IL-13 e IL-17 in patients with asthma.attacks.
4 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Respiratory Diseases, Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose Luis Carrillo Alduenda, Instituto Nacional De Enfermedades Respiratorias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C34-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Through this organization and will be provided at the individual request of each interested researcher.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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