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
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