Cystic FibrosisNCT01636219
Cough Efficiency in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Sheba Medical Center.
Trial summary
The major causes of morbidity and mortality in Cystic Fibrosis (CF) are linked to the process of chronic inflammatory of the airway, leading to the progressive damage of the small bronchioles and subsequently to the proximal bronchi. Read more about this study
- Who is it for?
- Ages 8 to 50 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Aug 2013
- Phase
- Observational
- 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 8 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Any CF patient visiting the pulmonary function laboratory, above 8 years old, who could cooperate with spirometry and who had no exacerbation, upon signing agreement consent
Who may be able to join
- Cooperation with spirometry
Who cannot join
- exacerbation, patients younger than 8 years.
About this study
The major causes of morbidity and mortality in Cystic Fibrosis (CF) are linked to the process of chronic inflammatory of the airway, leading to the progressive damage of the small bronchioles and subsequently to the proximal bronchi. A connection between weaknesses of respiratory muscles in CF and deficits of CFTR in the muscle has been established. Insufficient cough in CF patients may advance re-current respiratory infections. A voluntary cough flow volume (C-FVC) profile incorporates the characteristics of the forced expiratory flow volume curve (FE-VC). The study aims to explore the correspondence of voluntary cough-flow-volume and maximum expiratory flow-volume maneuvers in relation to disease complications in CF patients.
Read the detailed description
Cystic fibrosis (CF) is the most common lethal life shortening genetic disease caused by mutations of the trans-membrane conductance regulator (CFTR) gene. The major causes of morbidity and mortality in CF are linked to the process of chronic inflammatory of the airway, leading to the progressive damage of the small bronchioles and subsequently to the proximal bronchi. Cough is a back-up mechanism for mucus clearance which comes into effect in health during emergency situations, such as following the inhalation of a foreign body, and in lung disease where often the primary host defense clearance mechanism, namely mucociliany clearance, is compromised
Several studies have showed a connection between weaknesses of respiratory muscles in CF and deficits of CFTR in the muscle; sustain infection of pseudomonas; lower than normal tension time index and low fat free mass [3-6]. Weakness of the respiratory muscle may insinuate insufficient cough in CF patients.
Effective cough is initiated in several mechanical stages: a) inhaling a variable amount of air, b) closure of the glottis, c) contraction of respiratory muscles, and d) forced expiration to residual volume [7-13] A voluntary cough flow volume (C-FVC) profile therefore, incorporates the characteristics of the forced expiratory flow volume curve (FEVC) in that the first "spike" represents the peak cough flow, and the volume exhaled by the cough corresponds with the vital capacity. The descending portion of the C-FVC including secondary spikes decrease in a linear fashion as lung volume goes down from total lung capacity to residual volume.10 similar to the FEVC flow decay. Any disturbance in either of the cough stages may impair its efficiency.
The aim of this study is to explore the information that can be gained on cough ability in a group of CF patients, by the performance of voluntary cough-flow-volume maneuver and in relation to the characteristics of a maximum expiratory flow-volume curve.
Study plan How does this advance the field? In this study we wish to evaluate for the first time the cough ability derived from the voluntary cough flow volume curve for detection of insufficient cough in patients with CF. We hope to show that the cough flow volume curve corresponds with changes in cough ability in these patients in relation to lung function deterioration.
What are the clinical implications? An objective following-up of cough ability deterioration may allow the opportunity to introduce special respiratory therapy for strengthening cough and ease secretion flow in these patients.
- Conditions
- Cystic Fibrosis
- Keywords
- Spirometry,, Cough
- Medical subject headings
- Cystic Fibrosis, Cough
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough flow volume indices compaired to healthy known data
The indices includs peak cough flow, Inspiratory capacity, number of cough spikes and cough vital capacity.
Measured: 2 years
Secondary outcomes (1)
forced vital capacity menuver
the cough flow volume curve is comapred to the forced vital capacity maneuver.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daphna Vilozni, PhD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636219
- Sponsor's protocol ID
- SHEBA-11-8709-OE-SMC
- Status last verified
- Feb 2014
- First submitted
- 5 Jul 2012
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Divangahi M, Matecki S, Dudley RW, Tuck SA, Bao W, Radzioch D, Comtois AS, Petrof BJ. Preferential diaphragmatic weakness during sustained Pseudomonas aeruginosa lung infection. Am J Respir Crit Care Med. 2004 Mar 15;169(6):679-86. doi: 10.1164/rccm.200307-949OC. Epub 2003 Dec 11.
PubMed 14670804Enright S, Chatham K, Ionescu AA, Unnithan VB, Shale DJ. The influence of body composition on respiratory muscle, lung function and diaphragm thickness in adults with cystic fibrosis. J Cyst Fibros. 2007 Nov 30;6(6):384-90. doi: 10.1016/j.jcf.2007.02.006. Epub 2007 Apr 2.
PubMed 17400035Divangahi M, Balghi H, Danialou G, Comtois AS, Demoule A, Ernest S, Haston C, Robert R, Hanrahan JW, Radzioch D, Petrof BJ. Lack of CFTR in skeletal muscle predisposes to muscle wasting and diaphragm muscle pump failure in cystic fibrosis mice. PLoS Genet. 2009 Jul;5(7):e1000586. doi: 10.1371/journal.pgen.1000586. Epub 2009 Jul 31.
PubMed 19649303Hayot M, Guillaumont S, Ramonatxo M, Voisin M, Prefaut C. Determinants of the tension-time index of inspiratory muscles in children with cystic fibrosis. Pediatr Pulmonol. 1997 May;23(5):336-43. doi: 10.1002/(sici)1099-0496(199705)23:53.0.co;2-i.
PubMed 9168507McCool FD, Leith DE. Pathophysiology of cough. Clin Chest Med. 1987 Jun;8(2):189-95.
PubMed 3621873Beardsmore CS, Wimpress SP, Thomson AH, Patel HR, Goodenough P, Simpson H. Maximum voluntary cough: an indication of airway function. Bull Eur Physiopathol Respir. 1987 Sep-Oct;23(5):465-72.
PubMed 3450329Pedersen OF, Lyager S, Ingram RH Jr. Airway dynamics in transition between peak and maximal expiratory flow. J Appl Physiol (1985). 1985 Dec;59(6):1733-46. doi: 10.1152/jappl.1985.59.6.1733.
PubMed 4077782Langlands J. The dynamics of cough in health and in chronic bronchitis. Thorax. 1967 Jan;22(1):88-96. doi: 10.1136/thx.22.1.88. No abstract available.
PubMed 6031920Bianchi C, Baiardi P. Cough peak flows: standard values for children and adolescents. Am J Phys Med Rehabil. 2008 Jun;87(6):461-7. doi: 10.1097/PHM.0b013e318174e4c7.
PubMed 18496248
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough Efficiency in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01636219
- Acronym / sponsor ID
- SHEBA-11-8709-OE-SMC
- Conditions
- Cystic Fibrosis
- Keywords
- Spirometry,, Cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Jul 2012 (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 major causes of morbidity and mortality in Cystic Fibrosis (CF) are linked to the process of chronic inflammatory of the airway, leading to the progressive damage of the small bronchioles and subsequently to the proximal bronchi. A connection between weaknesses of respiratory muscles in CF and deficits of CFTR in the muscle has been established. Insufficient cough in CF patients may advance re-current respiratory infections. A voluntary cough flow volume (C-FVC) profile incorporates the characteristics of the forced expiratory flow volume curve (FE-VC). The study aims to explore the correspondence of voluntary cough-flow-volume and maximum expiratory flow-volume maneuvers in relation to disease complications in CF patients.
Detailed description
Cystic fibrosis (CF) is the most common lethal life shortening genetic disease caused by mutations of the trans-membrane conductance regulator (CFTR) gene. The major causes of morbidity and mortality in CF are linked to the process of chronic inflammatory of the airway, leading to the progressive damage of the small bronchioles and subsequently to the proximal bronchi. Cough is a back-up mechanism for mucus clearance which comes into effect in health during emergency situations, such as following the inhalation of a foreign body, and in lung disease where often the primary host defense clearance mechanism, namely mucociliany clearance, is compromised
Several studies have showed a connection between weaknesses of respiratory muscles in CF and deficits of CFTR in the muscle; sustain infection of pseudomonas; lower than normal tension time index and low fat free mass [3-6]. Weakness of the respiratory muscle may insinuate insufficient cough in CF patients.
Effective cough is initiated in several mechanical stages: a) inhaling a variable amount of air, b) closure of the glottis, c) contraction of respiratory muscles, and d) forced expiration to residual volume [7-13] A voluntary cough flow volume (C-FVC) profile therefore, incorporates the characteristics of the forced expiratory flow volume curve (FEVC) in that the first "spike" represents the peak cough flow, and the volume exhaled by the cough corresponds with the vital capacity. The descending portion of the C-FVC including secondary spikes decrease in a linear fashion as lung volume goes down from total lung capacity to residual volume.10 similar to the FEVC flow decay. Any disturbance in either of the cough stages may impair its efficiency.
The aim of this study is to explore the information that can be gained on cough ability in a group of CF patients, by the performance of voluntary cough-flow-volume maneuver and in relation to the characteristics of a maximum expiratory flow-volume curve.
Study plan How does this advance the field? In this study we wish to evaluate for the first time the cough ability derived from the voluntary cough flow volume curve for detection of insufficient cough in patients with CF. We hope to show that the cough flow volume curve corresponds with changes in cough ability in these patients in relation to lung function deterioration.
What are the clinical implications? An objective following-up of cough ability deterioration may allow the opportunity to introduce special respiratory therapy for strengthening cough and ease secretion flow in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Any CF patient visiting the pulmonary function laboratory, above 8 years old, who could cooperate with spirometry and who had no exacerbation, upon signing agreement consent
Key inclusion criteria (1 listed)
- Cooperation with spirometry
Key exclusion criteria (1 listed)
- exacerbation, patients younger than 8 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cough flow volume indices compaired to healthy known data
Time frame: 2 years
The indices includs peak cough flow, Inspiratory capacity, number of cough spikes and cough vital capacity.
1 secondary outcome
forced vital capacity menuver
Time frame: 2 years
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 7 Feb 2014.
- Background: PubMed 14670804Divangahi M, Matecki S, Dudley RW, Tuck SA, Bao W, Radzioch D, Comtois AS, Petrof BJ. Preferential diaphragmatic weakness during sustained Pseudomonas aeruginosa lung infection. Am J Respir Crit Care Med. 2004 Mar 15;169(6):679-86. doi: 10.1164/rccm.200307-949OC. Epub 2003 Dec 11.
- Background: PubMed 17400035Enright S, Chatham K, Ionescu AA, Unnithan VB, Shale DJ. The influence of body composition on respiratory muscle, lung function and diaphragm thickness in adults with cystic fibrosis. J Cyst Fibros. 2007 Nov 30;6(6):384-90. doi: 10.1016/j.jcf.2007.02.006. Epub 2007 Apr 2.
- Background: PubMed 19649303Divangahi M, Balghi H, Danialou G, Comtois AS, Demoule A, Ernest S, Haston C, Robert R, Hanrahan JW, Radzioch D, Petrof BJ. Lack of CFTR in skeletal muscle predisposes to muscle wasting and diaphragm muscle pump failure in cystic fibrosis mice. PLoS Genet. 2009 Jul;5(7):e1000586. doi: 10.1371/journal.pgen.1000586. Epub 2009 Jul 31.
- Background: PubMed 9168507Hayot M, Guillaumont S, Ramonatxo M, Voisin M, Prefaut C. Determinants of the tension-time index of inspiratory muscles in children with cystic fibrosis. Pediatr Pulmonol. 1997 May;23(5):336-43. doi: 10.1002/(sici)1099-0496(199705)23:53.0.co;2-i.
- Background: PubMed 3621873McCool FD, Leith DE. Pathophysiology of cough. Clin Chest Med. 1987 Jun;8(2):189-95.
- Background: PubMed 3450329Beardsmore CS, Wimpress SP, Thomson AH, Patel HR, Goodenough P, Simpson H. Maximum voluntary cough: an indication of airway function. Bull Eur Physiopathol Respir. 1987 Sep-Oct;23(5):465-72.
- Background: PubMed 4077782Pedersen OF, Lyager S, Ingram RH Jr. Airway dynamics in transition between peak and maximal expiratory flow. J Appl Physiol (1985). 1985 Dec;59(6):1733-46. doi: 10.1152/jappl.1985.59.6.1733.
- Background: PubMed 6031920Langlands J. The dynamics of cough in health and in chronic bronchitis. Thorax. 1967 Jan;22(1):88-96. doi: 10.1136/thx.22.1.88. No abstract available.
- Background: PubMed 18496248Bianchi C, Baiardi P. Cough peak flows: standard values for children and adolescents. Am J Phys Med Rehabil. 2008 Jun;87(6):461-7. doi: 10.1097/PHM.0b013e318174e4c7.
Related trials for Cystic Fibrosis
RecruitingPhase 1
Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Active, not recruitingObservational study
Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease
Cystic Fibrosis, Liver Disease
RecruitingObservational study
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Cystic Fibrosis (CF)
Active, not recruitingObservational study
Gene Modifiers of Cystic Fibrosis Lung Disease
Cystic Fibrosis, Lung Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Sheba Medical Center.
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 1 inclusion and 1 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 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Cough flow volume indices compaired to healthy known data (time frame: 2 years). 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 NCT01636219, which also lists 9 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 7 Feb 2014.