NCT04317326

"Mid- and Long-term Effectiveness of Positive Airway Pressure in OHS After an Acute-on-chronic Hypercapnic Respiratory Failure"

Withdrawn NA Last updated 9 May 2023

What this trial tests

NA trial testing "Lifestyle modifications" group (Control) in Acute on Chronic Hypercapnic Respiratory Failure. Withdrawn.

Timeline

1 January 2023

Primary endpoint
1 December 2028

1 December 2029

Quick facts

Lead sponsor	Juan F. Masa
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 January 2023
Primary completion	1 December 2028
Estimated completion	1 December 2029

Drugs / interventions tested

• "Lifestyle modifications" group (Control)
• Automatic NIV
• CPAP treatment group
• NIV treatment groups

Conditions studied

• Acute on Chronic Hypercapnic Respiratory Failure — all drugs for Acute on Chronic Hypercapnic Respiratory Failure →
• Obesity Hypoventilation Syndrome (OHS) — all drugs for Obesity Hypoventilation Syndrome (OHS) →

Sponsor

Juan F. Masa

Who can join

Adults 18 to 85, any sex, with Acute on Chronic Hypercapnic Respiratory Failure or Obesity Hypoventilation Syndrome (OHS). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Medium-term composite hospital resource utilization-mortality
  Time frame: 3 months
  Primary (medium-term from the first phase or RCT): the medium-term efficacy of automatic NIV treatment versus "lifestyle modifications" treatment in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events
• Long-term composite hospital resource utilization-mortality
  Time frame: 3 years
  Primary (long-term from the second phase or RCT): the long-term efficacy of titrated CPAP therapy versus titrated NIV therapy in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events

Sponsor's own description

We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized patients with recently diagnosed OHS be discharged from the hospital on an auto-titratable NIV treatment until the diagnosis of OHS is confirmed in 3 months? 2) Is the long-term effectiveness of outpatient titrated CPAP non-inferior to titrated NIV in ambulatory patients with OHS 3 months after hospital discharge? Clinical practice, multicenter open-label controlled randomized clinical trial with preset allocation rate (1:1) with two parallel-groups conducted in centers from Spain, France, Portugal and USA. The study will have two phases with two randomizations. The first phase will be a superiority study and the second phase will be a non-inferiority study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.