Spinal Cord InjuriesNCT01659541
Stimulation With Wire Leads to Restore Cough
A study testing Expiratory muscle stimulator and Implantation of device in people with Spinal Cord Injuries and Spinal Cord Diseases, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis
- What is being tested?
- Expiratory muscle stimulator and Implantation of device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury C8 level or higher
- 12 months post-injury (if the American Spinal Injury Association (ASIA) Impairment Scale (AIS) incomplete) or 6 months post-injury (if AIS complete)
- Expiratory muscle weakness
- Between 18 and 75 years of age
- Adequate oxygenation
Who cannot join
- Untreated lung, cardiovascular or brain disease
- Scoliosis, chest wall deformity, or marked obesity
- Unmanaged hypertension (high blood pressure) or hypotension (low blood pressure)
- Low oxygenation
- Minor infection at the site of implantation requiring antibiotics within the past 3 weeks
- Serious infection requiring hospitalization within the past 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Cord Stimulation With Wire Leads to Restore Cough
The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.
Read the detailed description
Patients with cervical spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. Expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough.
The purpose of this trial is to determine if electrical stimulation of the expiratory muscles by wire leads is capable of producing an effective cough on demand. According to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning - which often requires the constant presence of trained personnel. It will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death.
In the trial, researchers will study 16 adults (18-75 years old) with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed - by a routine, minimally invasive surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough, Trauma, Nervous System
- Being tested
- Expiratory muscle stimulator, Implantation of device
- Keywords
- spinal cord injury, paralysis, cough, cervical spinal cord injury, thoracic spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough, Trauma, Nervous System, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory muscle stimulatorDevice
Also called Custom Finetech/Ardiem Sacral Anterior Root Stimulator
The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.
Implantation of deviceProcedure or surgery
The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box to stimulate the expiratory muscles and restore cough.
| Study group | Role | What they receive |
|---|---|---|
| Procedure & Device | Experimental | Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator Receives: Device: Expiratory muscle stimulator; Procedure: Implantation of device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
Peak Expiratory airflow rate is a person's maximum speed of expiration. Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. It was measured after release of airway occlusion after peak airway pressure was achieved.
Measured: 52 weeks (1 year)
Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.
Measured: 52 weeks (1 year)
Secondary outcomes (4)
Secretion Management Episodes
This assessment allowed to characterize the severity of secretion management episodes and subjective assessment of the need for secretion management before and after use of the Cough System.
Design: Prospective assessment via questionnaire responses
Question: How significant were your needs for assistance with managing your airway secretions on a typical day during the past week?
0 None - Unaware of need
- Mild - Did not interfere with usual daily activities
- Moderate - Most stop activity during need
- Marked - Most stop activity for brief period (10-30 min) after need
- Severe - Most stop activity for prolonged period (> 30 min) after need, may be accompanied by dizziness, headache and/or pain in upper chest
Measured: 52 weeks (1 year)
Difficulty Raising Sputum
Survey to assess difficulty raising sputum
Objectives: To determine the difficulty raising sputum before and after use of the cough stimulation system (Cough System)
Design: Prospective assessment via questionnaire responses
Question: How much difficulty have you had with managing your airway secretions?
On a scale of 0-4 (0 = None (No secretions), 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty).
Measured: 52 weeks (1 year)
Number of Respiratory Tract Infections
Form covers frequency, type, severity, and antibiotic use for respiratory tract infections.
The incidence of acute respiratory tract infections, defined by a change in the character, color, or amount of respiratory secretions and requiring antibiotic administration was tracked before and after implantation of the cough system. The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available.
Measured: 52 weeks (1 year)
Life Quality Assessment -Stress Level
Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions.
Objectives: Life Quality Assessment before and after use of the cough stimulation system (Cough System)
Design: Prospective assessment via questionnaire responses
Question: To what extent did managing your airway secretions cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much)
Measured: 52 weeks (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startApr 2015
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Anthony F. Dimarco, MetroHealth Medical Center
- Investigators
- Anthony F. DiMarco, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659541
- Sponsor's protocol ID
- IRB 15-00014
- Other IDs
- U01NS083696
- Status last verified
- Nov 2022
- First submitted
- 23 May 2012
- Last updated
- 8 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Spinal cord stimulation: a new method to produce an effective cough in patients with spinal cord injury. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1386-9. doi: 10.1164/rccm.200601-097CR. Epub 2006 Mar 16.
PubMed 16543552DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-Sponsored clinical trial. Part II: clinical outcomes. Arch Phys Med Rehabil. 2009 May;90(5):726-32. doi: 10.1016/j.apmr.2008.11.014.
PubMed 19406290DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of expiratory muscle activation. Arch Phys Med Rehabil. 2009 May;90(5):717-25. doi: 10.1016/j.apmr.2008.11.013.
PubMed 19406289Kowalski KE, DiMarco AF. Comparison of wire and disc leads to activate the expiratory muscles in dogs. J Spinal Cord Med. 2011 Nov;34(6):600-8. doi: 10.1179/2045772311Y.0000000039.
PubMed 22330116DiMarco AF, Romaniuk JR, Supinski GS. Electrical activation of the expiratory muscles to restore cough. Am J Respir Crit Care Med. 1995 May;151(5):1466-71. doi: 10.1164/ajrccm.151.5.7735601.
PubMed 7735601DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Pattern of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol (1985). 1999 Jun;86(6):1881-9. doi: 10.1152/jappl.1999.86.6.1881.
PubMed 10368352DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Mechanical contribution of expiratory muscles to pressure generation during spinal cord stimulation. J Appl Physiol (1985). 1999 Oct;87(4):1433-9. doi: 10.1152/jappl.1999.87.4.1433.
PubMed 10517775Wada JA, Osawa T, Mizoguchi T. Recurrent spontaneous seizure state induced by prefrontal kindling in senegalese baboons, Papio papio. Can J Neurol Sci. 1975 Nov;2(4):477-92. doi: 10.1017/s031716710002062x.
PubMed 1201534Romaniuk JR, Dick TE, Kowalski KE, Dimarco AF. Effects of pulse lung inflation on chest wall expiratory motor activity. J Appl Physiol (1985). 2007 Jan;102(1):485-91. doi: 10.1152/japplphysiol.00130.2006. Epub 2006 Sep 7.
PubMed 16959914Kowalski KE, Romaniuk JR, DiMarco AF. Changes in expiratory muscle function following spinal cord section. J Appl Physiol (1985). 2007 Apr;102(4):1422-8. doi: 10.1152/japplphysiol.00870.2006. Epub 2006 Dec 7.
PubMed 17158247DiMarco AF, Kowalski KE, Romaniuk JR. Effects of diaphragm activation on airway pressure generation during lower thoracic spinal cord stimulation. Respir Physiol Neurobiol. 2007 Oct 15;159(1):102-7. doi: 10.1016/j.resp.2007.06.007. Epub 2007 Jun 22.
PubMed 17681870DiMarco AF, Kowalski KE. Effects of chronic electrical stimulation on paralyzed expiratory muscles. J Appl Physiol (1985). 2008 Jun;104(6):1634-40. doi: 10.1152/japplphysiol.01321.2007. Epub 2008 Apr 10.
PubMed 18403449DiMarco AF, Kowalski KE, Hromyak DR, Geertman RT. Long-term follow-up of spinal cord stimulation to restore cough in subjects with spinal cord injury. J Spinal Cord Med. 2014 Jul;37(4):380-8. doi: 10.1179/2045772313Y.0000000152. Epub 2013 Nov 26.
PubMed 24090524DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. Economic Consequences of an Implanted Neuroprosthesis in Subjects with Spinal Cord Injury for Restoration of an Effective Cough. Top Spinal Cord Inj Rehabil. 2017 Summer;23(3):271-278. doi: 10.1310/sci2303-271.
PubMed 29339903DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. Case report: Minimally invasive method to activate the expiratory muscles to restore cough. J Spinal Cord Med. 2018 Sep;41(5):562-566. doi: 10.1080/10790268.2017.1357916. Epub 2017 Oct 11.
PubMed 29017400
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation With Wire Leads to Restore Cough
- ClinicalTrials.gov ID
- NCT01659541
- Acronym / sponsor ID
- IRB 15-00014
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough, Trauma, Nervous System
- Keywords
- spinal cord injury, paralysis, cough, cervical spinal cord injury, thoracic spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Posted 19 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.
Detailed description
Patients with cervical spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. Expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough.
The purpose of this trial is to determine if electrical stimulation of the expiratory muscles by wire leads is capable of producing an effective cough on demand. According to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning - which often requires the constant presence of trained personnel. It will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death.
In the trial, researchers will study 16 adults (18-75 years old) with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed - by a routine, minimally invasive surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure & Device | Experimental | Device: Expiratory muscle stimulator, Procedure: Implantation of deviceProcedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Spinal cord injury C8 level or higher
- 12 months post-injury (if the American Spinal Injury Association (ASIA) Impairment Scale (AIS) incomplete) or 6 months post-injury (if AIS complete)
- Expiratory muscle weakness
- Between 18 and 75 years of age
- Adequate oxygenation
Key exclusion criteria (6 listed)
- Untreated lung, cardiovascular or brain disease
- Scoliosis, chest wall deformity, or marked obesity
- Unmanaged hypertension (high blood pressure) or hypotension (low blood pressure)
- Low oxygenation
- Minor infection at the site of implantation requiring antibiotics within the past 3 weeks
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 |
|---|---|---|
| Expiratory muscle stimulatorAlso: Custom Finetech/Ardiem Sacral Anterior Root StimulatorThe expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box. | Device | Procedure & Device |
| Implantation of deviceThe expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box to stimulate the expiratory muscles and restore cough. | Procedure or surgery | Procedure & Device |
Primary outcome
Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.
Time frame: 52 weeks (1 year)
Peak Expiratory airflow rate is a person's maximum speed of expiration. Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. It was measured after release of airway occlusion after peak airway pressure was achieved.
Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
Time frame: 52 weeks (1 year)
Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.
4 secondary outcomes
Secretion Management Episodes
Time frame: 52 weeks (1 year)
Difficulty Raising Sputum
Time frame: 52 weeks (1 year)
Number of Respiratory Tract Infections
Time frame: 52 weeks (1 year)
Life Quality Assessment -Stress Level
Time frame: 52 weeks (1 year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16543552DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Spinal cord stimulation: a new method to produce an effective cough in patients with spinal cord injury. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1386-9. doi: 10.1164/rccm.200601-097CR. Epub 2006 Mar 16.
- Background: PubMed 19406290DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-Sponsored clinical trial. Part II: clinical outcomes. Arch Phys Med Rehabil. 2009 May;90(5):726-32. doi: 10.1016/j.apmr.2008.11.014.
- Background: PubMed 19406289DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of expiratory muscle activation. Arch Phys Med Rehabil. 2009 May;90(5):717-25. doi: 10.1016/j.apmr.2008.11.013.
- Background: PubMed 22330116Kowalski KE, DiMarco AF. Comparison of wire and disc leads to activate the expiratory muscles in dogs. J Spinal Cord Med. 2011 Nov;34(6):600-8. doi: 10.1179/2045772311Y.0000000039.
- Background: PubMed 7735601DiMarco AF, Romaniuk JR, Supinski GS. Electrical activation of the expiratory muscles to restore cough. Am J Respir Crit Care Med. 1995 May;151(5):1466-71. doi: 10.1164/ajrccm.151.5.7735601.
- Background: PubMed 10368352DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Pattern of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol (1985). 1999 Jun;86(6):1881-9. doi: 10.1152/jappl.1999.86.6.1881.
- Background: PubMed 10517775DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Mechanical contribution of expiratory muscles to pressure generation during spinal cord stimulation. J Appl Physiol (1985). 1999 Oct;87(4):1433-9. doi: 10.1152/jappl.1999.87.4.1433.
- Background: PubMed 1201534Wada JA, Osawa T, Mizoguchi T. Recurrent spontaneous seizure state induced by prefrontal kindling in senegalese baboons, Papio papio. Can J Neurol Sci. 1975 Nov;2(4):477-92. doi: 10.1017/s031716710002062x.
- Background: PubMed 16959914Romaniuk JR, Dick TE, Kowalski KE, Dimarco AF. Effects of pulse lung inflation on chest wall expiratory motor activity. J Appl Physiol (1985). 2007 Jan;102(1):485-91. doi: 10.1152/japplphysiol.00130.2006. Epub 2006 Sep 7.
- Background: PubMed 17158247Kowalski KE, Romaniuk JR, DiMarco AF. Changes in expiratory muscle function following spinal cord section. J Appl Physiol (1985). 2007 Apr;102(4):1422-8. doi: 10.1152/japplphysiol.00870.2006. Epub 2006 Dec 7.
- Background: PubMed 17681870DiMarco AF, Kowalski KE, Romaniuk JR. Effects of diaphragm activation on airway pressure generation during lower thoracic spinal cord stimulation. Respir Physiol Neurobiol. 2007 Oct 15;159(1):102-7. doi: 10.1016/j.resp.2007.06.007. Epub 2007 Jun 22.
- Background: PubMed 18403449DiMarco AF, Kowalski KE. Effects of chronic electrical stimulation on paralyzed expiratory muscles. J Appl Physiol (1985). 2008 Jun;104(6):1634-40. doi: 10.1152/japplphysiol.01321.2007. Epub 2008 Apr 10.
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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.
Anthony F. DiMarco, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory muscle stimulator and Implantation of device in people with Spinal Cord Injuries and Spinal Cord Diseases, run by MetroHealth Medical Center at 1 site in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 8 Dec 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough. (time frame: 52 weeks (1 year)). The study lists 2 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 NCT01659541, which also lists 22 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 8 Dec 2022.