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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273830
• Other study ID #: 20131001
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: October 2017

Study information

• Verified date: August 2018
• Source: Hospital de Granollers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• oxygen
Oxygen administered after adjustment during a waking test or at 3L/min

Locations

Country	Name	City	State
Spain	Hospital General de Granollers	Granollers	BArcelona

Sponsors (5)

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

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Andersson A, Ström 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. — View 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. Review. — View 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. — View Citation

Jolly EC, Di Boscio V, Aguirre L, Luna CM, Berensztein S, Gené RJ. Effects of supplemental oxygen during activity in patients with advanced COPD without severe resting hypoxemia. Chest. 2001 Aug;120(2):437-43. — View 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. — View 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. Epub 2007 Apr 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	Reduce breathlessness during exercise	Reduce breathlessness during exercise	3 months
Secondary	Increase exercise capacity	Increase exercise capacity	3 months
Secondary	Increasing physical activity	Increasing physical activity	3 months