Expiratory flow limitation and heliox breathing in resting and exercising chronic obstructive pulmonary disease (COPD) patients
| ISRCTN | ISRCTN15098442 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15098442 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/05/2009
- Registration date
- 03/06/2009
- Last edited
- 11/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Edgardo D'Angelo
Scientific
Scientific
Dipartimento di Fisiologia Umana
via Mangiagalli 32
Milano
20133
Italy
| edgardo.dangelo@unimi.it |
Study information
| Study design | Randomised double-blind cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Local Ethics Committee (Comitato Etico Azienda Ospedaliera San Paolo) approved on the 24th January 2007 (ref: 599 CE/MA/) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Heliox |
| Primary outcome measure | 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 study start date | 01/02/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 26 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Dipartimento di Fisiologia Umana
Milano
20133
Italy
20133
Italy
Sponsor information
University of Milan (Univrsità degli Studi di Milano) (Italy)
University/education
University/education
Via Festa del Perdono, 7
Milano
20122
Italy
| Phone | +39 (0)2 503 111 |
|---|---|
| a@b.com | |
| Website | http://www.unimi.it/ |
"ROR" |
https://ror.org/00wjc7c48 |
Funders
Funder type
Government
Ministry of Education, University and Scientific Research (Ministero dell'Istruzione, dell'Università e della Ricerca Scientifica) (MIUR) (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/12/2009 | 11/07/2019 | Yes | No |
Editorial Notes
11/07/2019: Publication reference and total final enrolment added.
