Clinical trial NCT03564236: Nasal High-Flow in COPD
Official title: Nasal High-Flow Therapy to Treat COPD Exacerbations: a Matter of Monitoring and Controlling Settings?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD Exacerbation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
name: Medisch Spectrum Twente
name: Albert Schweitzer Hospital
name: Technical University of Twente
name: Fisher and Paykel Healthcare
name: Vivisol
First posted: 2018-06-20
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paralell-group randomised controlled trial
Primary purpose: TREATMENT

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.

Detailed description: The study will be a parallel group 2-arms non blinded multicentre 2-phase randomised controlled trial comparing the effect of nHFT on subjective recovery in COPD patients admitted to the hospital for a COPD exacerbation as compared to the standard care. First, we will define the optimal setting and gain more insight in insight in mechanisms why and how nHFT might work in a subpopulation, then continuing with inclusion in the randomized controlled trial including the 136 patients in total to prove efficacy in terms of patient-centered outcomes. To get more insight in mechanisms why and how nHFT might work we incorporate: a) neuromechanical investigations and analyses; and b) anatomical investigations, both in patients and in experimental models, the latter in order to minimise patient effort.

Eligibility criteria: Inclusion Criteria:

Patients have to fulfil all of the following inclusion criteria:

* 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

Exclusion Criteria:

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).

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: 90 days
Secondary outcomes:
measure: Treatment failure
timeFrame: 90 days, follow-up up to 1 year
measure: Hospitalisations
timeFrame: 90 days, follow-up up to 1 year
measure: Exacerbation frequency
timeFrame: 90 days, follow-up up to 1 year
measure: Severe Respiratory Insufficiency Questionnaire (SRI)
timeFrame: 90 days
measure: Clinical COPD Questionnaire (CCQ)
timeFrame: 90 days
measure: Euroqual-5 Dimensions questionnaire (EQ-5D)
timeFrame: 90 days
measure: Cough and Sputum Assessment Questionnaire (CASA-Q)
timeFrame: 90 days
measure: Gas exchange
timeFrame: 90 days
measure: Functional capacity
timeFrame: discharge and after 90 days
measure: Assessment of cardiac function
timeFrame: 90 days
measure: Compliance
timeFrame: 90 days
measure: Cost-effectiveness
timeFrame: 90 days
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweizer ziekenhuis
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: