Condition category
Respiratory
Date applied
04/05/2009
Date assigned
03/06/2009
Last edited
03/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Edgardo D'Angelo

ORCID ID

Contact details

Dipartimento di Fisiologia Umana
via Mangiagalli 32
Milano
20133
Italy
edgardo.dangelo@unimi.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

The effect of heliox (80% He, 20% O2) administration on breathing patterns and exercise capacity in patients with chronic obstructive pulmonary disease (COPD) is controversial. The objective of this study is to assess if tidal expiratory flow limitation affects the mechanical response of the respiratory system to heliox breathing during non-fatiguing exercises in patients with COPD. Tidal expiratory flow limitation, inspiratory capacity, breathing pattern and dyspnoea sensation will be assessed in stable patients during air and heliox breathing at rest and at 1/3 and 2/3 maximal work rate.

Previous results obtained with heliox in COPD patients at rest suggest that tidal expiratory flow limitation could play an important role in the response to heliox administration. So, our study will be focused on assessing if tidal expiratory flow limitation affects the mechanical response of the respiratory system to heliox breathing during non-fatiguing exercises in patients with COPD in basal condition.

Ethics approval

Local Ethics Committee (Comitato Etico Azienda Ospedaliera San Paolo) approved on the 24th January 2007 (ref: 599 CE/MA/)

Study design

Randomised double-blind cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

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 while cycling at 1/3 and 2/3 max for 6 - 8 minutes at each work level, measurements were taken when a quasi-steady breathing pattern had established. The test sequence was randomised.
3. Both at rest and during exercise, 4 - 6 negative expiratory pressure (NEP) tests were performed, followed by maximal inspirations to assess inspiratory capacity (IC), a reliable and commonly used procedure

Intervention type

Drug

Phase

Not Applicable

Drug names

Heliox

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/02/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant 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

Recruitment start date

01/02/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Dipartimento di Fisiologia Umana
Milano
20133
Italy

Sponsor information

Organisation

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

Sponsor details

Via Festa del Perdono
7
Milano
20122
Italy
+39 (0)2 503 111

Sponsor type

University/education

Website

http://www.unimi.it/

Funders

Funder type

Government

Funder name

Ministry of Education, University and Scientific Research (Ministero dell'Istruzione, dell'Università e della Ricerca Scientifica) (MIUR) (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes