Nasal High-Flow in COPD

NCT03564236 | Recruiting

• 1 other identifier: 201800398
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 3

Brief Summary

Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Since therapeutic options to treat exacerbations effectively are limited, many patients have persistent loss of vital functioning and suffer from frequent re-hospitalisations. Nasal high flow therapy (nHFT) is an innovative therapy that provides humidified and heated air through a nasal cannula. Although there is some preliminary evidence that nHFT is effective in stable COPD patients, there are no data at all regarding the effectiveness of nHFT in COPD exacerbations. A key problem in the implementation of nHFT is that the underlying working mechanisms are not clear and therefore the appropriate way to apply nHFT is unknown. Objective: The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background for optimal settings of nHFT. Study design: The study will be designed as a multicentre randomised controlled trial, with the University Medical Center Groningen, the "Medisch Spectrum Twente", "Albert Schweizer ziekenhuis", Rijnstate hospital, and the University of Twente, collaborating. Study population: One hundred thirty-six patients with known COPD GOLD stage II to IV and hypoxemic respiratory failure hospitalised with a COPD exacerbation will be included. Intervention (if applicable): Patients will be randomised to standard care or nHFT (≥ 6 hours/day) during hospitalisation and the 90 days after discharge, as added to standard care. Main study parameters/endpoints: The primary outcome will be improvement in HRQoL after 90 days.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life

  The primary outcome will be improvement in HRQoL, defined as the net response rate on the St. George Respiratory questionnaire (SGRQ) after 90 days

  90 days

Secondary Outcomes (12)

• Treatment failure

  90 days, follow-up up to 1 year

• Hospitalisations

  90 days, follow-up up to 1 year

• Exacerbation frequency

  90 days, follow-up up to 1 year

• Severe Respiratory Insufficiency Questionnaire (SRI)

  90 days

• Clinical COPD Questionnaire (CCQ)

  90 days

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Standard care is provided according to our local COPD exacerbation protocol. All patients are treated with: * oral prednisolone 40 mg/day for 5 days; * antibiotics prescribed according to the following criteria: fever (body temperature \> 38.5 degrees Celsius), elevated C-reactive protein (CRP) \>50, change in sputum colour, and/or according to the physician's decision of severe illness, and/or in all patients with a FEV1 \<30% of predicted; * high dose inhaled corticosteroids, beta-agonists and or anticholinergics. * Oxygen will be prescribed in all patients through a standard low flow system in order to maintain an adequate arterial oxygen saturation (Sa,O2) Patients will be discharged with regular low flow oxygen once they fulfil the criteria for long-term oxygen therapy.

Other: Standard care

Nasal High Flow Therapy

EXPERIMENTAL

In addition to the standard care described above, patients in the intervention group will be treated with: * nHFT, set at 30-50 L/min flow with oxygen to achieve an adequate oxygen saturation. nHFT is prescribed for at least 6 hours, but patients are stimulated to use the device as much as possible during the hospital stay. * During periods without HFT through a standard low flow system, to maintain an adequate arterial oxygen saturation (Sa,O2) (between 90-92% if patients are concomitantly hypercapnic, and between 90-95% if patients are normocapnic). Flow rates are titrated accordingly. * After discharge patients in the nHFT arm will continue the prescribed therapy at home for 90 subsequent days.

Device: Nasal High Flow Therapy

Interventions

Nasal High Flow Therapy DEVICE

Nasal High Flow Therapy (nHFT) is an innovative therapy for patients with respiratory diseases. It supplies heated, humidified, and oxygen-enriched air at high flow rates through a nasal cannula. Because the air is provided through an open system with a nasal cannula, it is relatively easy to apply and suggested to be very comfortable for patients. The technique has been shown to be effective in the treatment of hypoxemic respiratory failure, mainly in neonates\[2\] and patients with acute hypoxemic respiratory failure on intensive care units (ICU).\[3\]

Nasal High Flow Therapy

Standard care OTHER

Standard regular care of a COPD exacerbation

Standard Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1\< 80% of predicted with an FEV1/forced vital capacity (FVC) ratio \<70), with a history of at least 10 pack years smoking.
• Being admitted to the hospital with a COPD exacerbation
• Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) ≥ 6.0 kPa and/or hypoxemia (partial arterial oxygen pressure (PaO2) ≤ 8.0 kPa at room air), with pH \> 7.34
• At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and/or antibiotics and/or hospital admission)
• Written informed consent is obtained

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• No lung function data available
• The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission
• Inability to comply with the tests
• The presence of another chronic lung disease (e.g. asthma, restrictive lung disease).

Sponsors & Collaborators

• Marieke Duiverman: lead
• Rijnstate Hospital: collaborator
• Medisch Spectrum Twente: collaborator
• Albert Schweitzer Hospital: collaborator
• Technical University of Twente: collaborator
• Fisher and Paykel Healthcare: collaborator
• Vivisol: collaborator

Study Sites (3)

Rijnstate Hospital

Arnhem, Netherlands

RECRUITING

Albert Schweizer ziekenhuis

Dordrecht, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Marieke L Duiverman, MD PhD

CONTACT

0031-50-3613200; m.l.duiverman@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Paralell-group randomised controlled trial

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 20, 2018
• Study Start: October 1, 2018
• Primary Completion: October 31, 2025
• Study Completion: December 30, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

NL (3)