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Expiratory flow limitation and heliox breathing in resting and exercising chronic obstructive pulmonary disease (COPD) patients

Expiratory flow limitation and heliox breathing in resting and exercising chronic obstructive pulmonary disease (COPD) patients: a randomised double-blind cross-over trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15098442
Enrollment
25
Registered
2009-06-03
Start date
2007-02-01
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease

Interventions

1. An incremental exercise test on a cycle ergometer while breathing ambient air 2. Breathing air for 10 minutes and then equilibration with heliox (20% O2, 80% He), both at rest and w

Sponsors

University of Milan (Univrsità degli Studi di Milano) (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Stable COPD patients with stable airway obstruction with any level of forced expiratory volume in one second (FEV1) value expressed of predicted 2. Male or female patients, 40 years of age or older 3. Patients must be current or ex-smokers with a smoking history of more than 10 pack years 4. Patients must be to able to perform technical acceptable pulmonary function tests and must be able to perform an incremental exercise test on a cycle ergometer

Exclusion criteria

Exclusion criteria: 1. Patients with a signficant disease other than COPD that conditioning a risk for exercise testing (this is evaluated by medical investigators) 2. Patients with a history of asthma 3. Patients with a diagnosis of paroxysmal tachycardia, atrial fibrillation and recent history of myocardial infarction (less of 2 years) 4. Known active tubercolosis 5. History of cystic fibrosis 6. Pregnant women 7. Patients aged more than 85 years old

Design outcomes

Primary

MeasureTime frame
To compare the ventilatory response to heliox administration in expiratory flow-limited and non flow-limited COPD patients both at rest and during normal, non-fatiguing physical activities.

Secondary

MeasureTime frame
1. Dyspnoea 2. Flow limitation 3. Forced expiratory volume in one second (FEV1) 4. Inspiratory capacity (IC) 5. Forced volume capacity (FVC)

Countries

Italy

Outcome results

None listed

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