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Cough Efficiency in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT01636219
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Daphna Vilozni, PhD, Sheba Medical Center

Brief 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. 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.

Condition or disease
Cystic Fibrosis

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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cough Efficiency in Cystic Fibrosis
Study Start Date : September 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. forced vital capacity menuver [ Time Frame: 2 years ]
    the cough flow volume curve is comapred to the forced vital capacity maneuver.



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Ages Eligible for Study:   8 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Cooperation with spirometry

Exclusion Criteria:

  • exacerbation, patients younger than 8 years.

Publications:

Responsible Party: Daphna Vilozni, PhD, Head of Pediatric Pulmonary Laboratory, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01636219     History of Changes
Other Study ID Numbers: SHEBA-11-8709-OE-SMC
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014

Keywords provided by Daphna Vilozni, PhD, Sheba Medical Center:
Spirometry,
Cough

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases