Assessment of Voluntary and Reflex Cough in Patients With ALS

Pilot Observational Study, Assessing PCEF of the Voluntary and Reflex Cough in Patients With ALS

This study aims to assess the presence and the intensity of voluntary and cough reflex in patients with amyotrophic lateral sclerosis (ALS), comparing the results with the healthy control group. The assessment of the cough is fundamental to verify the mechanism of airways protection which is particularly compromised in ALS patients.

Objective parameters of voluntary and reflex cough would be measured by the spirometer. The reflex of cough would be elicited by a solution of citric acid through an ultrasonic nebulizer.

Study Overview

• Status: Unknown
• Conditions: Cough; ALS
• Intervention / Treatment: Other: Cough Assessment in ALS Patients

Detailed Description

Protocol:

1. Volitional Cough assessment by spirometer (Pony FX- Cosmed): a) Forced vital capacity (FVC); b) Volume Tidal; c) Maximum Espiratory Pressure (MEP); d) Maximum Inspiratory Pressure (MIP); e) Peak of Cough Expiratory Flow.
2. Cough Reflex would be trigged by the inhalation of 0.4M of citric acid solution using the ultrasonic nebulizer (MO-03 Norditalia Elettromedicali) connected with the spirometer and the nebulizer via a bidirectional valve. It would be measured the Peak of Cough Expiratory Flow.

Participants:

It would be recruited 60 subjects at the IRCCS Ospedale San Camillo Venezia (Italy). All participants have to provide informed consent independently. The study group is composed by thirty participants with diagnosis of ALS and the severity score of Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS). The control group consist of thirty healthy subjects matched by aged and sex with the study group.

Statistical consideration:

The variables measured will be summarized by means and standard deviations or by proportions. Numeric variables MIP-MEP-FVC-Vt-PCEF will be analyzed using the Shapiro-Wilk test to verify the normality of distribution. Depending on the outcome, for the comparison between groups will be used or the t-test (parametric) or the test of Mann Whitney (non-parametric) for independent samples.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Venice, Italy, 30126
    • Recruiting
    • Fondazione Ospedale San Camillo IRCCS
    • Contact: Battel Irene; Phone Number: 3395317706; Email: irene.battel@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of ALS
• Consensus

Exclusion Criteria:

• Smokers
• Oxygen Therapy
• Invasive Ventilation
• Allergy of citrus
• Asthma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALS Patients; Study Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer	Other: Cough Assessment in ALS Patients; Volitional Cough assessment by spirometer:a) Peak Cough Espiratory Flow (PCEF); Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)
Other: Healthy Subjects; Control group matched by aged and sex with the study group	Other: Cough Assessment in ALS Patients; Volitional Cough assessment by spirometer:a) Peak Cough Espiratory Flow (PCEF); Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCEF of RC in ALS	Peak of Cough Expiratory Flow during reflex cough in ALS patients	6 weeks
PCEF of VC in ALS	Peak of Cough Expiratory Flow during volitional cough in ALS patients	6 weeks
PCEF of RC in healthy subjects	Peak of Cough Expiratory Flow during reflex cough in healthy subjects	6 weeks
PCEF of VC in healthy subjects	Peak of Cough Expiratory Flow during during volitional cough in healthy subjects	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCEF of VC in ALS and control group	Comparison of PCEF of the voluntary cough between the 2 groups	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCEF of RF in ALS and control group	Comparison of PCEF of the reflex cough between the 2 groups	8 weeks

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy
• Investigators: Principal Investigator: IRENE BATTEL, IRCCS San Camillo, Venezia, Italy

Publications and helpful links

General Publications

• Widdicombe JG, Addington WR, Fontana GA, Stephens RE. Voluntary and reflex cough and the expiration reflex; implications for aspiration after stroke. Pulm Pharmacol Ther. 2011 Jun;24(3):312-7. doi: 10.1016/j.pupt.2011.01.015. Epub 2011 Feb 19.
• Luchesi KF, Kitamua S, Mourao LF. Amyotrophic Lateral Sclerosis survival analysis: Swallowing and non-oral feeding. NeuroRehabilitation. 2014;35(3):535-42. doi: 10.3233/NRE-141149.
• Zoccolella S, Beghi E, Palagano G, Fraddosio A, Samarelli V, Lamberti P, Lepore V, Serlenga L, Logroscino G; SLAP registry. Predictors of delay in the diagnosis and clinical trial entry of amyotrophic lateral sclerosis patients: a population-based study. J Neurol Sci. 2006 Dec 1;250(1-2):45-9. doi: 10.1016/j.jns.2006.06.027. Epub 2006 Aug 22.
• Miles A, Huckabee ML. Intra- and inter-rater reliability for judgement of cough following citric acid inhalation. Int J Speech Lang Pathol. 2013 Apr;15(2):209-15. doi: 10.3109/17549507.2012.692812. Epub 2012 Aug 8.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: ALS and Dysphagia; ALS and cough; cough reflex test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: TRSLA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No