Efficacy of Behavioral Therapy for Chronic Refractory Cough

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: Recruiting
• Conditions: Chronic Cough
• Intervention / Treatment: Behavioral: Behavioral Therapy

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: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Shaaban Mohamed Mahfouz, Resident; Phone Number: +201094817965; Email: mhamedshaaban6@gmail.com

Study Locations

• Egypt
  • Asyut, Egypt
    • Recruiting
    • Assuit University hospitals
    • Contact: Eman Sayed Hassan, Professor; Phone Number: +201004082014; Email: eshh2003@aun.edu.eg
    • Contact: Mohamed Fawzy Hassan, Professor; Phone Number: +201003032335; Email: adam@aun.edu.eg

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Eman Sayed Hassan, Professor, Head of Phoniatric unit,ENT Department,Faculty of Medicine, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 10, 2027

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Cough; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID 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