Anti-inflammatory Effect of Nocturnal NIPPV on Acute Asthma

NCT03154762 | Completed FDA Device

• 1 other identifier: C34-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Asthma Acute

Outcome Measures

Primary Outcomes (1)

• Systemic Inflammation

  To evaluate the effect of NIPPV on C reactive protein in patients with asthma attacks.

  4 days

Secondary Outcomes (5)

• Hospitalization

  4 days

• Adherence

  4 days

• Gas Exchange

  4 days

• Local Inflammation

  4 days

• Serum Inflammation

  4 days.

Study Arms (2)

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.

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.

Device: CPAP

Interventions

NIPPV DEVICE

Application of chronic distension of the airway through NIPPV to produce a reduction in bronchial hyperreactivity.

Also known as: bilevel

NIPPV

CPAP DEVICE

4 cmH2O CPAP as the minimum pressure necessary to mobilize the air flow and avoid the space death with no effect on the ventilation.

CPAP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias

Mexico City, 14080, Mexico

Location

Related Publications (3)

• 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.

  PMID: 17050561 RESULT

• Xue 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.

  PMID: 21493723 RESULT

• Salerno 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.

  PMID: 15475599 RESULT

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jose Luis Carrillo Alduenda

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Similar equipment will be used, the programming of the positive pressure device will be performed by an external person and a cover will be placed on the screen.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Experimental, prospective, longitudinal, comparative, parallel group study

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 16, 2017
• Study Start: June 1, 2017
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)