Clinical trial NCT02495571: Assessment of Voluntary and Reflex Cough in Patients With ALS
Official title: Pilot Observational Study, Assessing PCEF of the Voluntary and Reflex Cough in Patients With ALS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ALS
Cough
Keywords: ALS and Dysphagia
ALS and cough
cough reflex test
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ALS
* Consensus

Exclusion Criteria:

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

Primary outcomes:
measure: PCEF of RC in ALS
timeFrame: 6 weeks
measure: PCEF of VC in ALS
timeFrame: 6 weeks
measure: PCEF of RC in healthy subjects
timeFrame: 6 weeks
measure: PCEF of VC in healthy subjects
timeFrame: 6 weeks
Secondary outcomes:
measure: PCEF of VC in ALS and control group
timeFrame: 8 weeks
Other outcomes:
measure: PCEF of RF in ALS and control group
timeFrame: 8 weeks
Locations:
city: Venice
country: Italy
facility: Fondazione Ospedale San Camillo IRCCS
Study officials:
affiliation: IRCCS San Camillo, Venezia, Italy
name: IRENE BATTEL
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1016/j.jns.2006.06.027. Epub 2006 Aug 22.
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.