DyspneaDPENCT02113839
Dyspnea in COPD: Relationship With Exacerbations Frequency
A study testing Spirometry, CO Exhaled breath and P01 in people with Dyspnea, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The perception of breathlessness varies significantly among COPD patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyspnea
- What is being tested?
- Spirometry, CO Exhaled breath and P01
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with diagnosis of COPD (Gold 2 or 3 or 4)
- >2 months from last exacerbation and no change in therapy
Who cannot join
- patients on regular sedative drugs
- patients with neuromuscular diseases
- patients with respiratory failure and/or in long-term oxygen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breathlessness Perception in COPD: Relationship With Exacerbation Frequency
The perception of breathlessness varies significantly among COPD patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations.
Cross-sectional comparison of breathlessness perception in COPD patients with frequent exacerbations or without frequent exacerbations.
To assess "Breathlessness Perception" the investigators will increase the ventilatory demand of the patients by CO2-rebreathing method.
Read the detailed description
The perception of breathlessness varies between individuals. This is a well-established concept in asthma, but mostly unexplored in COPD; the relationship between airflow limitation (FEV1, % ref.) and breathlessness (mMRC) is weak.
The perception of breathlessness varies significantly among COPD patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations.
It is a cross-sectional comparison of breathlessness perception in COPD patients with frequent exacerbations (≥2 or ≥1 with hospitalization in the previous year) or without frequent exacerbations (0 or 1 without hospitalization in the previous year).
To assess "Breathlessness Perception" the investigators will increase the ventilatory demand of the patients by CO2-rebreathing method. CO2 rebreathing test will be conducted to evaluate the acute ventilatory response to CO2 inhalation used to estimate central chemoreceptor responsiveness in patients with the obstructive pulmonary disease.
Simple descriptive statistics (unpaired T-test) and correlation analysis (bivariate and multivariate) will be used to analyze results.
- Conditions
- Dyspnea
- Being tested
- Spirometry, CO Exhaled breath, P01, FeNO
- Keywords
- Dyspnea perception, COPD, Exacerbations, CO2 rebreathing test
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryProcedure or surgery
Also called FEV1, FVC, FEV1/FVC, VC
Before re-breathing (if the patient not performed one 6 months in advance).
CO Exhaled breathProcedure or surgery
Also called CO (ppm), COHb (%)
In current smokers of both arms to confirm that the patient has not smoked in the past three hours and to asses the smoking status (heavy, moderate, light).
P01Procedure or surgery
P01 is the negative airway pressure generated during the first 100 ms of an occluded inspiration. It's an estimation of the neuromuscular drive to breathe.
FeNOProcedure or surgery
The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.
| Study group | Role | What they receive |
|---|---|---|
| No frequent exacerbators | Active comparator | Patients without exacerbations: 0 or 1 that did not required hospitalization in the previous year.
Interventions:
* Spirometry
* Emogas analysis
* Modified Borg Dyspnea Scale
* CO Exhaled breath
* P01
* FeNO Receives: Procedure: Spirometry; Procedure: CO Exhaled breath; Procedure: P01; Procedure: FeNO |
| Frequent exacerbators | Active comparator | Patients with frequent exacerbations: ≥2 or ≥1 if it required hospitalization in the previous year.
Interventions:
* Spirometry
* Emogas analysis
* Modified Borg Dyspnea Scale
* CO Exhaled breath
* P01
* FeNO Receives: Procedure: Spirometry; Procedure: CO Exhaled breath; Procedure: P01; Procedure: FeNO |
What is being measured
The primary outcome is the main question the study is designed to answer.
The negative airway pressure generated during the first 100 ms of an occluded inspiration, which is an estimation of the neuromuscular drive to breathe. (P01 )
Measured: Baseline
Secondary outcomes (5)
Borg scale
10-point subjective scoring system, in which a patient rates his/her effort of exertion.
Measured: Baseline
Fractional exhaled nitric oxide (FeNO)
Measured: Baseline
Inspiratory capacity (IC)
The sum of inspiratory reserve volume and tidal volume.
Measured: Baseline
Ventilation at rest
Measured: Baseline
CO exhaled test
Testing for Carbon Monoxide in exhaled breath in current smokers.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Blanco, Hospital Clinic of Barcelona
- Investigators
- Isabel Blanco Vich, MD, PhD, Principal investigator, Hospital ClínicAlvar G Agustí, MD, PhD, Study director, Hospital Clínic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113839
- Sponsor's protocol ID
- DysPerEx
- Acronym
- DPE
- Status last verified
- Apr 2014
- First submitted
- 4 Apr 2014
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Davis SQ, Permutt Z, Permutt S, Naureckas ET, Bilderback AL, Rand CS, Stein BD, Krishnan JA. Perception of airflow obstruction in patients hospitalized for acute asthma. Ann Allergy Asthma Immunol. 2009 Jun;102(6):455-61. doi: 10.1016/S1081-1206(10)60117-2.
PubMed 19558002Miravitlles M, Anzueto A, Legnani D, Forstmeier L, Fargel M. Patient's perception of exacerbations of COPD--the PERCEIVE study. Respir Med. 2007 Mar;101(3):453-60. doi: 10.1016/j.rmed.2006.07.010. Epub 2006 Aug 30.
PubMed 16938447Agusti A, Calverley PM, Celli B, Coxson HO, Edwards LD, Lomas DA, MacNee W, Miller BE, Rennard S, Silverman EK, Tal-Singer R, Wouters E, Yates JC, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) investigators. Characterisation of COPD heterogeneity in the ECLIPSE cohort. Respir Res. 2010 Sep 10;11(1):122. doi: 10.1186/1465-9921-11-122.
PubMed 20831787Garcia-Aymerich J, Gomez FP, Benet M, Farrero E, Basagana X, Gayete A, Pare C, Freixa X, Ferrer J, Ferrer A, Roca J, Galdiz JB, Sauleda J, Monso E, Gea J, Barbera JA, Agusti A, Anto JM; PAC-COPD Study Group. Identification and prospective validation of clinically relevant chronic obstructive pulmonary disease (COPD) subtypes. Thorax. 2011 May;66(5):430-7. doi: 10.1136/thx.2010.154484. Epub 2010 Dec 21.
PubMed 21177668Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, Thwin SS, Huang GD, Robbins R, Sriram PS, Sharafkhaneh A, Mador MJ, Sarosi G, Panos RJ, Rastogi P, Wagner TH, Mazzuca SA, Shannon C, Colling C, Liang MH, Stoller JK, Fiore L, Niewoehner DE. A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial. Ann Intern Med. 2012 May 15;156(10):673-83. doi: 10.7326/0003-4819-156-10-201205150-00003.
PubMed 22586006Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.
PubMed 20843247Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.
PubMed 10843984Seemungal TA, Donaldson GC, Bhowmik A, Jeffries DJ, Wedzicha JA. Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 May;161(5):1608-13. doi: 10.1164/ajrccm.161.5.9908022.
PubMed 10806163Jones PW, Nadeau G, Small M, Adamek L. Characteristics of a COPD population categorised using the GOLD framework by health status and exacerbations. Respir Med. 2014 Jan;108(1):129-35. doi: 10.1016/j.rmed.2013.08.015. Epub 2013 Aug 30.
PubMed 24041746Agusti AG, Villaverde JM, Togores B, Bosch M. Serial measurements of exhaled nitric oxide during exacerbations of chronic obstructive pulmonary disease. Eur Respir J. 1999 Sep;14(3):523-8. doi: 10.1034/j.1399-3003.1999.14c08.x.
PubMed 10543270Parker J, Wolansky LJ, Khatry D, Geba GP, Molfino NA. Brain magnetic resonance imaging in adults with asthma. Contemp Clin Trials. 2011 Jan;32(1):86-9. doi: 10.1016/j.cct.2010.09.006. Epub 2010 Sep 18.
PubMed 20854931Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
PubMed 17507545Scioscia G, Blanco I, Arismendi E, Burgos F, Gistau C, Foschino Barbaro MP, Celli B, O'Donnell DE, Agusti A. Different dyspnoea perception in COPD patients with frequent and infrequent exacerbations. Thorax. 2017 Feb;72(2):117-121. doi: 10.1136/thoraxjnl-2016-208332. Epub 2016 Sep 1.
PubMed 27586869
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathlessness Perception in COPD: Relationship With Exacerbation Frequency
- ClinicalTrials.gov ID
- NCT02113839
- Acronym / sponsor ID
- DPE / DysPerEx
- Conditions
- Dyspnea
- Keywords
- Dyspnea perception, COPD, Exacerbations, CO2 rebreathing test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The perception of breathlessness varies significantly among COPD patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations.
Cross-sectional comparison of breathlessness perception in COPD patients with frequent exacerbations or without frequent exacerbations.
To assess "Breathlessness Perception" the investigators will increase the ventilatory demand of the patients by CO2-rebreathing method.
Detailed description
The perception of breathlessness varies between individuals. This is a well-established concept in asthma, but mostly unexplored in COPD; the relationship between airflow limitation (FEV1, % ref.) and breathlessness (mMRC) is weak.
The perception of breathlessness varies significantly among COPD patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations.
It is a cross-sectional comparison of breathlessness perception in COPD patients with frequent exacerbations (≥2 or ≥1 with hospitalization in the previous year) or without frequent exacerbations (0 or 1 without hospitalization in the previous year).
To assess "Breathlessness Perception" the investigators will increase the ventilatory demand of the patients by CO2-rebreathing method. CO2 rebreathing test will be conducted to evaluate the acute ventilatory response to CO2 inhalation used to estimate central chemoreceptor responsiveness in patients with the obstructive pulmonary disease.
Simple descriptive statistics (unpaired T-test) and correlation analysis (bivariate and multivariate) will be used to analyze results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No frequent exacerbators | Active comparator | Procedure: Spirometry, Procedure: CO Exhaled breath, Procedure: P01, Procedure: FeNOPatients without exacerbations: 0 or 1 that did not required hospitalization in the previous year. Interventions: * Spirometry * Emogas analysis * Modified Borg Dyspnea Scale * CO Exhaled breath * P01 * FeNO |
| Frequent exacerbators | Active comparator | Procedure: Spirometry, Procedure: CO Exhaled breath, Procedure: P01, Procedure: FeNOPatients with frequent exacerbations: ≥2 or ≥1 if it required hospitalization in the previous year. Interventions: * Spirometry * Emogas analysis * Modified Borg Dyspnea Scale * CO Exhaled breath * P01 * FeNO |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with diagnosis of COPD (Gold 2 or 3 or 4)
- >2 months from last exacerbation and no change in therapy
Key exclusion criteria (3 listed)
- patients on regular sedative drugs
- patients with neuromuscular diseases
- patients with respiratory failure and/or in long-term oxygen therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometryAlso: FEV1, FVC, FEV1/FVC, VCBefore re-breathing (if the patient not performed one 6 months in advance). | Procedure or surgery | Frequent exacerbators, No frequent exacerbators |
| CO Exhaled breathAlso: CO (ppm), COHb (%)In current smokers of both arms to confirm that the patient has not smoked in the past three hours and to asses the smoking status (heavy, moderate, light). | Procedure or surgery | Frequent exacerbators, No frequent exacerbators |
| P01P01 is the negative airway pressure generated during the first 100 ms of an occluded inspiration. It's an estimation of the neuromuscular drive to breathe. | Procedure or surgery | Frequent exacerbators, No frequent exacerbators |
| FeNOThe measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal. | Procedure or surgery | Frequent exacerbators, No frequent exacerbators |
Primary outcome
The negative airway pressure generated during the first 100 ms of an occluded inspiration, which is an estimation of the neuromuscular drive to breathe. (P01 )
Time frame: Baseline
5 secondary outcomes
Borg scale
Time frame: Baseline
Fractional exhaled nitric oxide (FeNO)
Time frame: Baseline
Inspiratory capacity (IC)
Time frame: Baseline
Ventilation at rest
Time frame: Baseline
CO exhaled test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Background: PubMed 19558002Davis SQ, Permutt Z, Permutt S, Naureckas ET, Bilderback AL, Rand CS, Stein BD, Krishnan JA. Perception of airflow obstruction in patients hospitalized for acute asthma. Ann Allergy Asthma Immunol. 2009 Jun;102(6):455-61. doi: 10.1016/S1081-1206(10)60117-2.
- Background: PubMed 16938447Miravitlles M, Anzueto A, Legnani D, Forstmeier L, Fargel M. Patient's perception of exacerbations of COPD--the PERCEIVE study. Respir Med. 2007 Mar;101(3):453-60. doi: 10.1016/j.rmed.2006.07.010. Epub 2006 Aug 30.
- Background: PubMed 20831787Agusti A, Calverley PM, Celli B, Coxson HO, Edwards LD, Lomas DA, MacNee W, Miller BE, Rennard S, Silverman EK, Tal-Singer R, Wouters E, Yates JC, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) investigators. Characterisation of COPD heterogeneity in the ECLIPSE cohort. Respir Res. 2010 Sep 10;11(1):122. doi: 10.1186/1465-9921-11-122.
- Background: PubMed 21177668Garcia-Aymerich J, Gomez FP, Benet M, Farrero E, Basagana X, Gayete A, Pare C, Freixa X, Ferrer J, Ferrer A, Roca J, Galdiz JB, Sauleda J, Monso E, Gea J, Barbera JA, Agusti A, Anto JM; PAC-COPD Study Group. Identification and prospective validation of clinically relevant chronic obstructive pulmonary disease (COPD) subtypes. Thorax. 2011 May;66(5):430-7. doi: 10.1136/thx.2010.154484. Epub 2010 Dec 21.
- Background: PubMed 22586006Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, Thwin SS, Huang GD, Robbins R, Sriram PS, Sharafkhaneh A, Mador MJ, Sarosi G, Panos RJ, Rastogi P, Wagner TH, Mazzuca SA, Shannon C, Colling C, Liang MH, Stoller JK, Fiore L, Niewoehner DE. A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial. Ann Intern Med. 2012 May 15;156(10):673-83. doi: 10.7326/0003-4819-156-10-201205150-00003.
- Background: PubMed 20843247Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.
- Background: PubMed 10843984Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.
- Background: PubMed 10806163Seemungal TA, Donaldson GC, Bhowmik A, Jeffries DJ, Wedzicha JA. Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 May;161(5):1608-13. doi: 10.1164/ajrccm.161.5.9908022.
- Background: PubMed 24041746Jones PW, Nadeau G, Small M, Adamek L. Characteristics of a COPD population categorised using the GOLD framework by health status and exacerbations. Respir Med. 2014 Jan;108(1):129-35. doi: 10.1016/j.rmed.2013.08.015. Epub 2013 Aug 30.
- Background: PubMed 10543270Agusti AG, Villaverde JM, Togores B, Bosch M. Serial measurements of exhaled nitric oxide during exacerbations of chronic obstructive pulmonary disease. Eur Respir J. 1999 Sep;14(3):523-8. doi: 10.1034/j.1399-3003.1999.14c08.x.
- Background: PubMed 20854931Parker J, Wolansky LJ, Khatry D, Geba GP, Molfino NA. Brain magnetic resonance imaging in adults with asthma. Contemp Clin Trials. 2011 Jan;32(1):86-9. doi: 10.1016/j.cct.2010.09.006. Epub 2010 Sep 18.
- Background: PubMed 17507545Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
Related trials for Dyspnea
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
Not yet recruiting
Visual and Auditory Stimulation in Intensive Care Patients
Dyspnea, Sleep Quality
Recruiting
The Effects of Wintergreen Essential Oil Inhalation on Alleviating Dyspnea Among Patients With Pneumonia
Pneumonia, Dyspnea
Not yet recruitingObservational study
Diaphragm Response in Elderly for Acute Monitoring
Acute Dyspnea, Acute Respiratory Failure
Recruiting
Telerehabilitation Exercise Program for Postoperative Recovery in Lung Cancer.
Lung Neoplasms, Thoracic Surgery Lung
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Blanco Vich, MD, PhD principal investigator
Hospital Clínic
Alvar G Agustí, MD, PhD study director
Hospital Clínic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry, CO Exhaled breath and P01 in people with Dyspnea, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The negative airway pressure generated during the first 100 ms of an occluded inspiration, which is an estimation of the neuromuscular drive to breathe. (P01 ) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113839, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.