Clinical Response of Syrup Hydryllin® in Pakistani Subjects With Cough in Routine Practice (HYD-EFFECT)

A cough is one of the most common medical complaints accounting for as many as 30 million clinical visits per year. It is the single most prevalent symptom on presentation to a physician's office. Up to 40% of these complaints result in a referral to a pulmonologist. Although, the cough is an essential defense mechanism, still, chronic cough may cause significant morbidity and substantially affect the quality of life and psychosocial wellbeing.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Drug: Syrup Hydryllin

Detailed Description

Globally, the prevalence of acute cough is 9 to 64%, whereas chronic cough is >10% in most countries or regions, ranging from 7.2%-33%. In Pakistan, a few studies have examined chronic cough resulting from specific occupations, such as those involving brick kilns, textile work, or gem cutting. Additionally, 15.8% of subjects in a periurban area of Karachi City, Pakistan with cough lasting ≥ 2 weeks were found to have pulmonary TB. Overall, to estimate the prevalence and incidence of different coughs, there is no data available based on the local population, and the data assessing the quality of life of patients with different coughs is not available. Locally, few studies were conducted on cough syrups with a small sample size. However, no real data is available for the symptomatic management of cough about the patient's quality of life related to different coughs. The current study is designed to assess the response of different strengths of Syrup Hydryllin ( Syrup Hydryllin & Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan & Diphenhydramine) in the symptomatic management of cough in routine practice by physicians. The study's main objective is to assess the quality of life of the subjects suffering from the different types of cough.

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 72500
      • The Searle Company Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population including patients of either sex between ≥12 and ≤70 years, suffering from cough (acute, subacute, and chronic), will be enrolled in the study in the random order. The random number will be marked using a random number table.

Description

Inclusion Criteria:

• Patient with a clinical history of cough.
• Patients aged ≥12 and ≤70 years inclusive of either sex.
• The patient will be screened for COVID-19
• The patient will be prescribed the study drug following an approved package insert
• Written informed consent before participation in study-specific procedures

Exclusion Criteria:

• Known hypersensitivity to Hydryllin product, the metabolites, or formulation excipients.
• Covid Patients with moderate and severe condition requires hospitalization or/and associated with the complications.
• Patients who have a contra-indication (refer to the Syrup Hydryllin prescribing information).
• Pregnant (assessed on LMP)
• Breastfeeding women (assessed on interview).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

• Patient with a clinical history of cough; Syrup Hydryllin ( Syrup Hydryllin & Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan & Diphenhydramine) in the symptomatic management of cough in routine practice by physicians. Subjects will be observed for overall safety and effectiveness of study drug from visit 1 (baseline visit, screening, and start of treatment), to visit 2 (Week 1-2, end of treatment) in the routine practice.

Drug: Syrup Hydryllin; ( Syrup Hydryllin & Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan & Diphenhydramine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• To assess the effectiveness of Syrup Hydryllin from baseline to 2 weeks -	The effectiveness assesses by Leicester Cough Questionnaire (QoL questionnaire), The LCQ scale from 1-7, 1 is all the time and 7 is none of the time. The total score is 19 whereas 8 for Physical, 7 for Psychological and 4 for Social.	4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• To assess the overall safety of different strengths of Syrup Hydryllin in the cases presenting with different types of cough.	The safety will be monitored from the first dose of HYDRYLLIN. The participants with treatment-related adverse events will be reported on Searle AE designed form.	4 Months

Collaborators and Investigators

• Sponsor: The Searle Company Limited Pakistan
• Investigators: Study Director: Syed Sarwar, The Searle Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cough management, Cough syrup, Quality of Life
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: TSCL_HYD-EFFECT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No