ALSNCT02495571
Assessment of Voluntary and Reflex Cough in Patients With ALS
A study testing Cough Assessment in ALS Patients in people with ALS and Cough, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Cough Assessment in ALS Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2015to Jun 2016
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of ALS
- Consensus
Who cannot join
- Smokers
- Oxygen Therapy
- Invasive Ventilation
- Allergy of citrus
- Asthma
Trial locations and contacts
1 site in 1 country.
Claudia Enrichi contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Ospedale San Camillo IRCCS
Venice, Venice, 30126
Battel Irene, 3395317706, irene.battel@gmail.com
About this study
Official title: 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.
Read the detailed description
Protocol:
- 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.
- 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.
- Being tested
- Cough Assessment in ALS Patients
- Keywords
- ALS and Dysphagia, ALS and cough, cough reflex test
- Medical subject headings
- Cough, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough Assessment in ALS PatientsOther
- Volitional Cough assessment by spirometer:
- Peak Cough Espiratory Flow (PCEF)
- Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)
| Study group | Role | What they receive |
|---|---|---|
| ALS Patients | Experimental | Study Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer Receives: Other: Cough Assessment in ALS Patients |
| Healthy Subjects | Other | Control group matched by aged and sex with the study group Receives: Other: Cough Assessment in ALS Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCEF of RC in ALS
Peak of Cough Expiratory Flow during reflex cough in ALS patients
Measured: 6 weeks
PCEF of VC in ALS
Peak of Cough Expiratory Flow during volitional cough in ALS patients
Measured: 6 weeks
PCEF of RC in healthy subjects
Peak of Cough Expiratory Flow during reflex cough in healthy subjects
Measured: 6 weeks
PCEF of VC in healthy subjects
Peak of Cough Expiratory Flow during during volitional cough in healthy subjects
Measured: 6 weeks
Secondary outcomes (1)
PCEF of VC in ALS and control group
Comparison of PCEF of the voluntary cough between the 2 groups
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ALSStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Battel, IRCCS San Camillo, Venezia, Italy
- Investigators
- IRENE BATTEL, Principal investigator, IRCCS San Camillo, Venezia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495571
- Sponsor's protocol ID
- TRSLA
- Status last verified
- Oct 2015
- First submitted
- 30 Jun 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21338708Luchesi 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.
PubMed 25238863Zoccolella 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.
PubMed 16920152Miles 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.
PubMed 22873621
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Observational Study, Assessing PCEF of the Voluntary and Reflex Cough in Patients With ALS
- ClinicalTrials.gov ID
- NCT02495571
- Acronym / sponsor ID
- TRSLA
- Keywords
- ALS and Dysphagia, ALS and cough, cough reflex test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 13 Jul 2015 (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.
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:
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS Patients | Experimental | Other: Cough Assessment in ALS PatientsStudy Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer |
| Healthy Subjects | Other | Other: Cough Assessment in ALS PatientsControl group matched by aged and sex with the study group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of ALS
- Consensus
Key exclusion criteria (5 listed)
- Smokers
- Oxygen Therapy
- Invasive Ventilation
- Allergy of citrus
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough Assessment in ALS Patients1. Volitional Cough assessment by spirometer: a) Peak Cough Espiratory Flow (PCEF) 2. Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF) | Other | ALS Patients, Healthy Subjects |
Primary outcome
PCEF of RC in ALS
Time frame: 6 weeks
Peak of Cough Expiratory Flow during reflex cough in ALS patients
PCEF of VC in ALS
Time frame: 6 weeks
Peak of Cough Expiratory Flow during volitional cough in ALS patients
PCEF of RC in healthy subjects
Time frame: 6 weeks
Peak of Cough Expiratory Flow during reflex cough in healthy subjects
PCEF of VC in healthy subjects
Time frame: 6 weeks
Peak of Cough Expiratory Flow during during volitional cough in healthy subjects
1 secondary outcome
PCEF of VC in ALS and control group
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 21338708Widdicombe 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.
- Background: PubMed 25238863Luchesi 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.
- Background: PubMed 16920152Zoccolella 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.
- Background: PubMed 22873621Miles 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.
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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.
Claudia Enrichi contact
IRENE BATTEL principal investigator
IRCCS San Camillo, Venezia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough Assessment in ALS Patients in people with ALS and Cough, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IRENE BATTEL (+393395317706, irene.battel@ospedalesancamillo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCEF of RC in ALS (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 NCT02495571, which also lists 4 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 14 Oct 2015.