The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With Hypoxemia

NCT04207593 | Completed Phase 2 DMC

• 1 other identifier: 2018-11SO*
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of O2 naïve patients with PAH will be included in this investigator-initiated trial (IIT) to assess efficacy and safety of oxygen substitution. Nocturnal oxygen substitution improved the 6MWD compared to placebo in one clinical trial in PAH patients. Due to the positive results in the treatment of patients with PAH, the initiation of this proof-of-concept study is justified.

Conditions

Oxygen Deficiency; Pulmonary Arterial Hypertension; CTEPH

Keywords

Oxygen; Pulmonary Arterial Hypertension; CTEPH; 6MWD

Outcome Measures

Primary Outcomes (1)

• 6-minute Walking distance

  To determine the benefits for PH patients from a long-term oxygen therapy (LTOT) given continuously during ≥16h/day for 12 weeks, measured by improvement of exercise performance assessed by the 6 minute walking distance (6MWD).

  Change from baseline to 6 months

Secondary Outcomes (23)

• Quality of life: physical Summation score; short form health Survey 36 (score from 0-100; higher scores indicating better outcome)

  Change from baseline to 6 months

• Quality of life: mental Summation score; short form health Survey 36 (score from 0-100; higher scores indicating better outcome)

  Change from baseline to 6 months

• Clinical worsening; frequency and type of clinical worsening events

  clinical worsening events from baseline to 6 months

• cardiac index in liters per minute per square meter (of body surface area) /(CI)

  Change from baseline to 6 months

• systolic pulmonary arterial pressure

  Change from baseline to 6 months

Study Arms (2)

Oxygen Therapy provided

ACTIVE COMPARATOR

Patients will be divided in a supplemental-oxygen group (primary intervention group) throughout the study

Drug: Oxygen

no-supplemental-oxygen group (control group)

SHAM COMPARATOR

Patients of the control group will beginn the study without Oxygen Therapie and will be offered to participate in the interventional treatment arm after they have terminated the control period (partial cross-over; secondary intervention group).

Drug: Oxygen

Interventions

Oxygen DRUG

Study medication will be oxygen (O2) in diverse concentrations, titrated until a SaO2\>90% or pO2 \>60 mmHg is achieved, for 20 patients vs. no supplemental O2 for 20 patients over 90 ± 7 days. Patients of the control group will be offered to participate in the interventional treatment arm after they have terminated the control period (partial cross-over; secondary intervention group). After the end of the study it is up to the judgment of the investigator to prescribe oxygen to all patients who might benefit from the treatment.

Also known as: Liquid oxygen

Oxygen Therapy provided; no-supplemental-oxygen group (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women 18 years of age or older

You may not qualify if:

• patient is willing and able to provide written informed consent
• patient is willing and able to comply with the protocol, including required follow-up visits
• Patients experiencing oxygen desaturations ≤90% (or pO2 below 60 mmHg) at rest and/or oxygen desaturations ≤90% (or pO2 below 60 mmHg) during physical activity
• Patient is a female who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control
• patient with pulmonary venous hypertension
• significant functional limitation in lung function tests (FEV1 \<60%,TLC \<60%) and CT morphological signs of pulmonary disease
• significant left heart disease, requiring acute pharmacological or interventional treatment
• unstable conditions requiring pharmacological or other treatment, intensive care or relevant severe concomitant disease
• patient is enrolled, has participated within the last thirty days, or is planning to participate, in a concurrent drug and/or device study during the course of this clinical trial. Co-enrolment in concurrent trials is only allowed with documented pre-approval from the study manager that there is not a concern that co-enrolment could confound the results of this trial.
• patient has been initiated on a new oral or parenteral PAH therapy in the last two weekspatient with a cardiac index (CI) \<1.8L/min/m\^2
• active smoking Status
• patient with severe resting desaturation (repeatedly SpO2 \<80%) or severe exercise-induced desaturation (SpO2 ≤75% for ≥10 minutes)

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Centre for pulmonary hypertension of the Thoraxclinic at the University Hospital Heidelberg

Heidelberg, 69126, Germany

Location

Related Publications (1)

• Ulrich S, Hasler ED, Saxer S, Furian M, Muller-Mottet S, Keusch S, Bloch KE. Effect of breathing oxygen-enriched air on exercise performance in patients with precapillary pulmonary hypertension: randomized, sham-controlled cross-over trial. Eur Heart J. 2017 Apr 14;38(15):1159-1168. doi: 10.1093/eurheartj/ehx099.

  PMID: 28329240 RESULT

MeSH Terms

Conditions

Hypoxia; Pulmonary Arterial Hypertension

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: PAH patients experiencing oxygen desaturations at rest and during physical activity, when O2 partial pressure is repeatedly \<8 kPa (\<60 mmHg; alternatively, 90% of O2 saturation). Patients will be divided in a supplemental-oxygen group (primary intervention group) and no-supplemental-oxygen group (control group). Patients of the control group will be offered to participate in the interventional treatment arm after they have terminated the control period (partial cross-over; secondary intervention group). Randomization will be performed in a 1:1 ratio. Randomization to one of the groups will be performed by block randomization. Randomization lists will be created by the data management using a computer to generate random numbers.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Ekkehard Grünig; Head of centre for pulmonary hypertension

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 23, 2019
• Study Start: April 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 10, 2023
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

DE (1)