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Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation During Exercise.

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

oxygen

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring oxygen therapy, COPD, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical stable moderate to severe COPD (FEV1 <70%, FEV 1 / FVC <70%) total lung capacity (TLC> 80%) without conventional criteria for LTOT, optimal medical therapy, mean SpO2 ≤ 88% during the 6 minuts walking test and active life outside the home, other than active smoking or are in program respiratory rehabilitation.

Exclusion Criteria:

Current smokers - Presence of respiratory failure and criteria for LTOT (PO2 <55 mmHg or 55-60 mmHg associated with pulmonary arterial hypertension, chronic cor pulmonale, congestive heart failure, arrhythmias or polycythemia). - Presence of impaired mobility - Cognitive impairment or intellectual disability to fill in questionnaires - No acceptance of liquid oxygen - Presence of active comorbidities (cardiovascular disease, rheumatologic, renal, hepatic) - Participation in pulmonary rehabilitation programs

Sites / Locations

Hospital General de Granollers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

oxygen adjusted

control group

Arm Description

oxygen adjusted to get SpO2> 90% during the walking test

oxygen at 3L/min

Outcomes

Primary Outcome Measures

Benefits on HRQOL

The aim is to analyze the benefits on HRQOL of suitable correction of desaturation in COPD patients without conventional criteria for OCD but with exercise desaturation.

Secondary Outcome Measures

Reduce breathlessness during exercise

Increase exercise capacity

Increasing physical activity

Full Information

NCT ID

NCT02273830

First Posted

October 22, 2014

Last Updated

August 6, 2018

Sponsor

Jtarrega

Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Mutua de Terrassa, Hospital Dos de Maig, Hospital Universitari Sant Joan de Reus

1. Study Identification

Unique Protocol Identification Number

NCT02273830

Brief Title

Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation During Exercise.

Official Title

Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation on Exercise But Without Conventional Criteria for Domiciliary Oxygen Therapy.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jtarrega

Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Mutua de Terrassa, Hospital Dos de Maig, Hospital Universitari Sant Joan de Reus

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is analyzed the impact of oxygen adjusted during exercise in COPD patients without conventional for LTOT but with exercise desaturation.

Detailed Description

Oxygen will be administered through nasal cannulae. Patients will be provided with a tank of liquid oxygen and a rechargeable portable device. The 6 minuts walking test will be used to adjusted oxygen flow in the GFA group (to achieve a mean SpO2 ≥ 90%). In the control group (GC), a 3L/min oxygen flow will be administer. Oxygen is used when the patient perform physical activity. The treatment period for each patient is 6 months (3 months in the GC grup, 3 months in the GFA one).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

oxygen therapy, COPD, exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oxygen adjusted

Arm Type

Active Comparator

Arm Description

oxygen adjusted to get SpO2> 90% during the walking test

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

oxygen at 3L/min

Intervention Type

Drug

Intervention Name(s)

oxygen

Intervention Description

Oxygen administered after adjustment during a waking test or at 3L/min

Primary Outcome Measure Information:

Title

Benefits on HRQOL

Description

The aim is to analyze the benefits on HRQOL of suitable correction of desaturation in COPD patients without conventional criteria for OCD but with exercise desaturation.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Reduce breathlessness during exercise

Description

Reduce breathlessness during exercise

Time Frame

3 months

Title

Increase exercise capacity

Description

Increase exercise capacity

Time Frame

3 months

Title

Increasing physical activity

Description

Increasing physical activity

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical stable moderate to severe COPD (FEV1 <70%, FEV 1 / FVC <70%) total lung capacity (TLC> 80%) without conventional criteria for LTOT, optimal medical therapy, mean SpO2 ≤ 88% during the 6 minuts walking test and active life outside the home, other than active smoking or are in program respiratory rehabilitation. Exclusion Criteria: Current smokers - Presence of respiratory failure and criteria for LTOT (PO2 <55 mmHg or 55-60 mmHg associated with pulmonary arterial hypertension, chronic cor pulmonale, congestive heart failure, arrhythmias or polycythemia). - Presence of impaired mobility - Cognitive impairment or intellectual disability to fill in questionnaires - No acceptance of liquid oxygen - Presence of active comorbidities (cardiovascular disease, rheumatologic, renal, hepatic) - Participation in pulmonary rehabilitation programs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JULIA TARREGA, PhD

Organizational Affiliation

Hospital General de Granollers

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital General de Granollers

City

Granollers

State/Province

BArcelona

ZIP/Postal Code

08402

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

6776858

Citation

Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.

Results Reference

background

PubMed Identifier

6110912

Citation

Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.

Results Reference

background

PubMed Identifier

9877478

Citation

Andersson A, Strom K, Brodin H, Alton M, Boman G, Jakobsson P, Lindberg A, Uddenfeldt M, Walter H, Levin LA. Domiciliary liquid oxygen versus concentrator treatment in chronic hypoxaemia: a cost-utility analysis. Eur Respir J. 1998 Dec;12(6):1284-9. doi: 10.1183/09031936.98.12061284.

Results Reference

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PubMed Identifier

17218587

Citation

Bradley JM, Lasserson T, Elborn S, Macmahon J, O'neill B. A systematic review of randomized controlled trials examining the short-term benefit of ambulatory oxygen in COPD. Chest. 2007 Jan;131(1):278-85. doi: 10.1378/chest.06-0180.

Results Reference

background

PubMed Identifier

11502641

Citation

Jolly EC, Di Boscio V, Aguirre L, Luna CM, Berensztein S, Gene RJ. Effects of supplemental oxygen during activity in patients with advanced COPD without severe resting hypoxemia. Chest. 2001 Aug;120(2):437-43. doi: 10.1378/chest.120.2.437.

Results Reference

background

PubMed Identifier

17446339

Citation

Nonoyama ML, Brooks D, Guyatt GH, Goldstein RS. Effect of oxygen on health quality of life in patients with chronic obstructive pulmonary disease with transient exertional hypoxemia. Am J Respir Crit Care Med. 2007 Aug 15;176(4):343-9. doi: 10.1164/rccm.200702-308OC. Epub 2007 Apr 19.

Results Reference

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Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation During Exercise.

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