Chronic CoughNCT07488598
Efficacy of Behavioral Therapy for Chronic Refractory Cough
A study testing Behavioral Therapy in people with Chronic Cough, run by Assiut University at 1 site in Egypt.
Trial summary
Chronic cough is defined as cough persisting for more than eight weeks. It is a common clinical problem that significantly impairs patients' physical, psychological, and social quality of life. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Cough
- What is being tested?
- Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2026to 10 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eligible participants are adults aged ≥18 years i.e. normal chest radiograph.
- participants with chronic cough persisting for more than eight weeks that is refractory to standard medical treatment for common causes of chronic cough, including asthma, gastroesophageal reflux disease .
- Participants are required to exhibit clinical features suggestive of laryngeal hyperresponsiveness, such as cough triggered by phonation, laughter, cold air, or irritant exposure, with associated laryngeal symptoms including throat irritation, dysphonia, or frequent throat clearing.
Who cannot join
- Patients are excluded if they are current smokers or had ceased smoking within six months
- patients have evidence of active pulmonary or cardiac disease, recent respiratory tract infection, recent angiotensin-converting enzyme inhibitor use.
- significant structural laryngeal pathology, neurological disorders affecting cough reflex control, or inability to comply with study procedures.
- Head \&neck pathology e.g sinusitis, glottal insufficiency or primary muscle tension dysphonia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assuit University hospitals
Asyut
Eman Sayed Hassan, Professor, +201004082014, eshh2003@aun.edu.eg
Mohamed Fawzy Hassan, Professor, +201003032335, adam@aun.edu.eg
About this study
Official title: Efficacy of Behavioral Therapy for Chronic Refractory Cough in Patients With Laryngeal Hyperresponsiveness
Chronic cough is defined as cough persisting for more than eight weeks. It is a common clinical problem that significantly impairs patients' physical, psychological, and social quality of life. Chronic cough remains a diagnostic and therapeutic challenge despite systematic evaluation and treatment of common etiologies such as asthma, gastroesophageal reflux disease
Read the detailed description
Chronic cough is defined as cough persisting for more than eight weeks. It is a common clinical problem that significantly impairs patients' physical, psychological, and social quality of life. Chronic cough remains a diagnostic and therapeutic challenge despite systematic evaluation and treatment of common etiologies such as asthma, gastroesophageal reflux disease .
A substantial proportion of patients continue to experience persistent symptoms and are increasingly classified under the umbrella of cough hypersensitivity syndrome, characterized by an exaggerated cough response to low-level mechanical, chemical, or thermal stimuli .
Laryngeal hyperresponsiveness represents a central pathophysiological feature of upper air way cough syndrome and is associated with heightened sensory and motor responses of the larynx, leading to symptoms such as throat irritation, dysphonia, frequent throat clearing, and cough triggered by talking, laughing, cold air, or exposure to strong odors.
Pharmacological therapies often provide limited or inconsistent benefit in those patients,prompting growing interest in non-pharmacological approaches, particularly behavioral cough suppression therapy delivered by speech-language pathologists.
Behavioral therapy is a multimodal intervention incorporating patient education, cough suppression techniques, breathing retraining, vocal hygiene counseling, and strategies aimed at reducing laryngeal irritation and maladaptive cough behaviors and improve voluntary control of the urge to cough.
Randomized controlled trials and observational studies have demonstrated that behavioral therapy can significantly reduce cough frequency, cough reflex sensitivity, and cough-related quality-of-life impairment, with particular benefit observed in patients with prominent laryngeal symptoms and heightened urge-to-cough.
A recent meta-analysis of 12 randomized and self-controlled trials provides robust evidence for Behavioral Cough Suppression Therapy (BCST), showing it significantly improves Leicester Cough Questionnaire scores and reduces objective cough frequency in patients with refractory or unexplained chronic cough.
Furthermore, a specific protocol known as Physiotherapy and Speech and Language Therapy Intervention (PSALTI) has demonstrated a 41% reduction in cough frequency in clinical trials.
Despite the Advantages of speech pathology intervention, there is limited guidance in the literature on when patients should be referred for treatment. Also, heterogeneity in patient selection, diagnostic criteria, and outcome measures highlights the Need for further evaluation of the Efficacy of behavioral therapy in well-defined population with laryngeal hyperresponsivness.
- Conditions
- Chronic Cough
- Being tested
- Behavioral Therapy
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TherapyBehavioural
Also called Laryngeal hyperresponsiveness
to evaluate the efficacy of behavioral therapy for chronic cough in patients with laryngeal hyperresponsiveness in order to assess its role as a non-pharmacological management strategy. This will provide an efficient plan of therapy for such challenging condition.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Therapy for chronic cough | Experimental | About 30 patients suffering from chronic cough persisting for more than eight weeks that is refractory to standard medical treatment for common causes of chronic cough, including asthma, gastroesophageal reflux disease Receives: Behavioral: Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Chronic Cough
The patient's subjective response to treatment, categorized as: resolved, improved, no change, or worse. it will be assisted by Cough-Specific Quality of Life: Leicester Cough Questionnaire (LCQ): The primary measure of cough-specific health-related quality of life (QoL). and also assesses physical, psychological, and social domains
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start10 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shaaban Mohamed, Assiut University
- Investigators
- Eman Sayed Hassan, Professor, Study chair, Head of Phoniatric unit,ENT Department,Faculty of Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488598
- Sponsor's protocol ID
- Chronic Refractory Cough
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Behavioral Therapy for Chronic Refractory Cough in Patients With Laryngeal Hyperresponsiveness
- ClinicalTrials.gov ID
- NCT07488598
- Acronym / sponsor ID
- Chronic Refractory Cough
- Conditions
- Chronic Cough
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- 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.
Chronic cough is defined as cough persisting for more than eight weeks. It is a common clinical problem that significantly impairs patients' physical, psychological, and social quality of life. Chronic cough remains a diagnostic and therapeutic challenge despite systematic evaluation and treatment of common etiologies such as asthma, gastroesophageal reflux disease
Detailed description
Chronic cough is defined as cough persisting for more than eight weeks. It is a common clinical problem that significantly impairs patients' physical, psychological, and social quality of life. Chronic cough remains a diagnostic and therapeutic challenge despite systematic evaluation and treatment of common etiologies such as asthma, gastroesophageal reflux disease .
A substantial proportion of patients continue to experience persistent symptoms and are increasingly classified under the umbrella of cough hypersensitivity syndrome, characterized by an exaggerated cough response to low-level mechanical, chemical, or thermal stimuli .
Laryngeal hyperresponsiveness represents a central pathophysiological feature of upper air way cough syndrome and is associated with heightened sensory and motor responses of the larynx, leading to symptoms such as throat irritation, dysphonia, frequent throat clearing, and cough triggered by talking, laughing, cold air, or exposure to strong odors.
Pharmacological therapies often provide limited or inconsistent benefit in those patients,prompting growing interest in non-pharmacological approaches, particularly behavioral cough suppression therapy delivered by speech-language pathologists.
Behavioral therapy is a multimodal intervention incorporating patient education, cough suppression techniques, breathing retraining, vocal hygiene counseling, and strategies aimed at reducing laryngeal irritation and maladaptive cough behaviors and improve voluntary control of the urge to cough.
Randomized controlled trials and observational studies have demonstrated that behavioral therapy can significantly reduce cough frequency, cough reflex sensitivity, and cough-related quality-of-life impairment, with particular benefit observed in patients with prominent laryngeal symptoms and heightened urge-to-cough.
A recent meta-analysis of 12 randomized and self-controlled trials provides robust evidence for Behavioral Cough Suppression Therapy (BCST), showing it significantly improves Leicester Cough Questionnaire scores and reduces objective cough frequency in patients with refractory or unexplained chronic cough.
Furthermore, a specific protocol known as Physiotherapy and Speech and Language Therapy Intervention (PSALTI) has demonstrated a 41% reduction in cough frequency in clinical trials.
Despite the Advantages of speech pathology intervention, there is limited guidance in the literature on when patients should be referred for treatment. Also, heterogeneity in patient selection, diagnostic criteria, and outcome measures highlights the Need for further evaluation of the Efficacy of behavioral therapy in well-defined population with laryngeal hyperresponsivness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Therapy for chronic cough | Experimental | Behavioral: Behavioral TherapyAbout 30 patients suffering from chronic cough persisting for more than eight weeks that is refractory to standard medical treatment for common causes of chronic cough, including asthma, gastroesophageal reflux disease |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Eligible participants are adults aged ≥18 years i.e. normal chest radiograph.
- participants with chronic cough persisting for more than eight weeks that is refractory to standard medical treatment for common causes of chronic cough, including asthma, gastroesophageal reflux disease .
- Participants are required to exhibit clinical features suggestive of laryngeal hyperresponsiveness, such as cough triggered by phonation, laughter, cold air, or irritant exposure, with associated laryngeal symptoms including throat irritation, dysphonia, or frequent throat clearing.
Key exclusion criteria (4 listed)
- Patients are excluded if they are current smokers or had ceased smoking within six months
- patients have evidence of active pulmonary or cardiac disease, recent respiratory tract infection, recent angiotensin-converting enzyme inhibitor use.
- significant structural laryngeal pathology, neurological disorders affecting cough reflex control, or inability to comply with study procedures.
- Head \&neck pathology e.g sinusitis, glottal insufficiency or primary muscle tension dysphonia
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 |
|---|---|---|
| Behavioral TherapyAlso: Laryngeal hyperresponsivenessto evaluate the efficacy of behavioral therapy for chronic cough in patients with laryngeal hyperresponsiveness in order to assess its role as a non-pharmacological management strategy. This will provide an efficient plan of therapy for such challenging condition. | Behavioural | Behavioral Therapy for chronic cough |
Primary outcome
Treatment of Chronic Cough
Time frame: 6 months
The patient's subjective response to treatment, categorized as: resolved, improved, no change, or worse. it will be assisted by Cough-Specific Quality of Life: Leicester Cough Questionnaire (LCQ): The primary measure of cough-specific health-related quality of life (QoL). and also assesses physical, psychological, and social domains
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Cough
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Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
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Feasibility, Acceptability, and Safety Trial of Brief, Breath Control-Focused Acceptance and Commitment Therapy in Adults With Chronic Cough
Chronic Cough
Not yet recruitingPhase 4
A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
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RecruitingPhase 2
A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough
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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.
Eman Sayed Hassan, Professor study chair
Head of Phoniatric unit,ENT Department,Faculty of Medicine, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Therapy in people with Chronic Cough, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Shaaban Mohamed Mahfouz, Resident (+201094817965, mhamedshaaban6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of Chronic Cough (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.