Clinical trial NCT02273830: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: oxygen therapy
COPD
exercise
Lead sponsor: Hospital de Granollers
Sponsor class: OTHER
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Hospital Mutua de Terrassa
name: Hospital Dos de Maig
name: Hospital Universitari Sant Joan de Reus
First posted: 2014-10-24
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Benefits on HRQOL
timeFrame: 3 months
Secondary outcomes:
measure: Reduce breathlessness during exercise
timeFrame: 3 months
measure: Increase exercise capacity
timeFrame: 3 months
measure: Increasing physical activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: BArcelona
Study officials:
affiliation: Hospital General de Granollers
name: JULIA TARREGA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.