Efficacy of Behavioral Therapy for Chronic Refractory Cough

April 19, 2026 updated by: Mohamed Shaaban Mohamed, Assiut University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Asyut, Egypt
        • Recruiting
        • Assuit University hospitals
        • Contact:
        • Contact:
          • Mohamed Fawzy Hassan, Professor
          • Phone Number: +201003032335
          • Email: adam@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Behavioral Therapy for chronic cough
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
Behavioral: Behavioral Therapy
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.
Other Names:
  • Laryngeal hyperresponsiveness

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Eman Sayed Hassan, Professor, Head of Phoniatric unit,ENT Department,Faculty of Medicine, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Chronic Refractory Cough

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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