COPD exacerbation - Heliox Therapy - Assessment Heliox vs. Medical Air in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Pilot Randomised Controlled Trial - Pilot CHeTA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005660-13-GB

Enrollment

Registered

2008-10-17

Start date

2008-12-11

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease MedDRA version: 9.1 Level: LLT Classification code 10010953 Term: COPD exacerbation

Interventions

Trade Name: Medicinal Air Product Name: Medicinal Air Pharmaceutical Form: Inhalation gas Trade Name: Heliox21 Product Name: Heliox21 Pharmaceutical Form: Inhalation gas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Be admitted to ED with a clinical diagnosis of an acute exacerbation of COPD (acute onset of a sustained worsening of the patient’s symptoms from their usual stable state which is beyond normal day-to-day variations). • Have a Past Medical History of a diagnosis of COPD • Age > 40 years. • After initial nebulisation have two of: RR>30, HR>100, purulent sputum Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Have left ventricular failure. • Unable to give informed consent. • Clinical anticipation of intubation or non-invasive ventilation before randomisation. • Have participated in this trial before. • Participation in any investigational drug study within 4 weeks preceding or during this study period. • Clinical suspicion of large consolidation. • Encephalopathic

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this pilot study is to test the trial protocol and procedures in preparation for a full-scale study, and to estimate the patient recruitment rates at the trial centres.;Secondary Objective: To gather data on the effects of Heliox inhalation during exacerbation of COPD for the purposes of sample size calculation and trial design for a full-scale clinical trial. The trial will collect information about blood gases (CO2, O2), blood pH,dyspnoea,vital signs, oxygenation, and nebulisation before and during treatment with a study gas (Heliox or Medical Air, with additional oxygen as required).;Primary end point(s): To evaluate the feasibility of study procedures and protocol, including the estimation of recruitment rate.	—

Measure

Time frame

Main Objective: The main objective of this pilot study is to test the trial protocol and procedures in preparation for a full-scale study, and to estimate the patient recruitment rates at the trial centres.;Secondary Objective: To gather data on the effects of Heliox inhalation during exacerbation of COPD for the purposes of sample size calculation and trial design for a full-scale clinical trial. The trial will collect information about blood gases (CO2, O2), blood pH,dyspnoea,vital signs, oxygenation, and nebulisation before and during treatment with a study gas (Heliox or Medical Air, with additional oxygen as required).;Primary end point(s): To evaluate the feasibility of study procedures and protocol, including the estimation of recruitment rate.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026