Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007339

Trial Description

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Title

Efficacy and Physiology of Nasal High Flow Therapy (AIRVO2™, Fisher&Paykel) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Hypercapnic Respiratory Failure

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive
hypercapnic respiratory failure are still not sufficiently known yet.

The aim of this study is a step-by-step generation of physiological data about gas exchange
and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to
provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise
capacity, quality of life and gas exchange in a long term home treatment compared to a
standard low flow long term oxygen therapy (LOT).

Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous
carbon dioxide partial pressure (PCO2) after four weeks of treatment.

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Brief Summary in Scientific Language

Stage 1: Respiratory Physiology Aim of this Stage is to investigate the effects of nasal
High Flow (NHF) therapy in patients in progressed stages of COPD, by measuring physiologic
parameters like tidal volume, breathing frequency and expiratory PCO2 concentration.

Stage 2: Efficacy of short term NHF Aim of this Stage is to evaluate the efficacy of two
flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For
this reason, patients will have two PSG sleep studies during their hospital stay, under 20
L/min and 35 L/min NHF therapy in randomized order.

Stage 3: Home Care monitoring Aim of this Stage is to compare long term influences of NHF
and LOT on PCO2 levels randomised crossover, 4 weeks each treatment.

Stage 4: Long Term Home Care monitoring Aim of this stage is the long term follow up (12
month) of patients to examine the compliance of a sufficient NHF therapy. Patients will
retain the NHF therapy if they are responders (PCO2 improvement in stage 3 of at least 2
mmHG with NHF versus LOT) and willing and able to use NHF and a patient log.

All patients will be monitored for the next 12 month. After 6 month there will be a control
phone call.

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Organizational Data

  •   DRKS00007339
  •   2016/03/11
  •   2014/03/07
  •   yes
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Secondary IDs

  •   NCT02083120  (ClinicalTrials.gov)
  •   AIRVOhome  (Institut für Pneumologie Hagen Ambrock eV)
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Health Condition or Problem studied

  •   Pulmonary Disease, Chronic Obstructive
  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
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Interventions/Observational Groups

  •   Device: NHF therapy
  •   Other: Long term Oxygen Therapy (LOT)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
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Primary Outcome

- mean overnight transcutaneous PCO2; time frame: baseline; In two baseline measurements the aim is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two polysomnographic sleep studies (PSG) during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.
Primary objective is the mean overnight transcutaneous PCO2 value, absolute as well as time spent >50 mmHg.
- mean overnight transcutaneous PCO2; time frame: after 4 weeks; In home care monitoring is the aim to compare long term influences of NHF and LOT on PCO2 levels. Primary objective is the mean overnight transcutaneous PCO2 level measured after 4 weeks of each treatment phase.
- mean overnight transcutaneous PCO2; time frame: after 12 month; All patients will be monitored under NHF or another sufficient therapy for the next 12 month followed by another mean overnight transcutaneous PCO2 level measure.

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Secondary Outcome

- quality of life with Saint Georges Respiratory Questionnaire (SGRQ); time frame: after 4 weeks, 8 weeks and 12 month; SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/04/30
  •   40
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   80   Years
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Additional Inclusion Criteria

- Age 40-80

- Male and female

- COPD patients with chronic respiratory insufficiency (pH >7.35 and PCO2 > 50mmHg)

- Stable respiratory situation

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Exclusion Criteria

- Decompensated heart, liver or kidney failure.

- Pregnancy or nursing period

- Participation in another clinical trial within the last 4 weeks

- Drug abuse

- Incapable of giving consent

- Known obstructive sleep apnea syndrome (OSA) (AHI>10)

- noninvasive ventilation (NIV) therapy

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Addresses

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    • Institut für Pneumologie Hagen Ambrock eV
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    • Fisher and Paykel Healthcare
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    •   [---]*
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    • Helios Klinik Ambrock
    • Georg Nilius, MD 
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    • Georg Nilius, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.