Assessment of Voluntary and Reflex Cough in Patients With ALS

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02495571
• Other study ID #: TRSLA
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2015
• Last updated: October 13, 2015
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: IRENE BATTEL
• Phone: +393395317706
• Email: irene.battel[@]ospedalesancamillo.net
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of ALS

• Consensus

Exclusion Criteria:

• Smokers

• Oxygen Therapy

• Invasive Ventilation

• Allergy of citrus

• Asthma

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• ALS
• Cough

Intervention

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)

Locations

Country	Name	City	State
Italy	Fondazione Ospedale San Camillo IRCCS	Venice

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Luchesi KF, Kitamua S, Mourão LF. Amyotrophic Lateral Sclerosis survival analysis: Swallowing and non-oral feeding. NeuroRehabilitation. 2014;35(3):535-42. doi: 10.3233/NRE-141149. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PCEF of RF in ALS and control group	Comparison of PCEF of the reflex cough between the 2 groups	8 weeks	No
Primary	PCEF of RC in ALS	Peak of Cough Expiratory Flow during reflex cough in ALS patients	6 weeks	No
Primary	PCEF of VC in ALS	Peak of Cough Expiratory Flow during volitional cough in ALS patients	6 weeks	No
Primary	PCEF of RC in healthy subjects	Peak of Cough Expiratory Flow during reflex cough in healthy subjects	6 weeks	No
Primary	PCEF of VC in healthy subjects	Peak of Cough Expiratory Flow during during volitional cough in healthy subjects	6 weeks	No
Secondary	PCEF of VC in ALS and control group	Comparison of PCEF of the voluntary cough between the 2 groups	8 weeks	No