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

NCT ID: NCT02273830

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-10-31

Brief Summary

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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

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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).

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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oxygen adjusted

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

Group Type ACTIVE_COMPARATOR

oxygen

Intervention Type DRUG

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

control group

oxygen at 3L/min

Group Type PLACEBO_COMPARATOR

oxygen

Intervention Type DRUG

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

Interventions

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oxygen

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role collaborator

Hospital Mutua de Terrassa

OTHER

Sponsor Role collaborator

Hospital Dos de Maig

UNKNOWN

Sponsor Role collaborator

Hospital Universitari Sant Joan de Reus

OTHER

Sponsor Role collaborator

Jtarrega

OTHER

Sponsor Role lead

Responsible Party

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Jtarrega

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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JULIA TARREGA, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General de Granollers

Locations

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Hospital General de Granollers

Granollers, BArcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 6776858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6110912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9877478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17218587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11502641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17446339 (View on PubMed)

Other Identifiers

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20131001

Identifier Type: -

Identifier Source: org_study_id

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