A clinical trial to study the effects of combination drug in patients suffering from Dry Cough associated with sneezing and running nose or throat irritation.

Phase 4

Recruiting

• Conditions: Acute upper respiratory infection,unspecified,

• Registration Number: CTRI/2022/11/047227
• Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary

This study is a single arm, open label, multicenter trial to evaluate safety and efficacy of fixed dose combination of dextromethorphan hydrobromide 30 mg and chlorpheniramine maleate sustained release 4mg/5ml suspension. Patients suffering from dry cough which is associated with sneezing and/ or running nose and/ or throat irritation will be given this combination of drug twice daily for7 days. Total number of patients in this trail are 230. This study will be conducted in 10 sites in India. The primary outcome will be of safety assessment including treatment emergent adverse events reported during the study, co- primary outcome will be change in severity of cough as per cough severity score from baseline. Secondary outcome will be evaluated as follows: change in frequency of cough, change in severity of sneezing, change in severity of running nose, change in severity of throat irritation.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-21
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Patient of either gender aged more than or equal to 6 years and ready to give written informed consent/assent to participate in the study at the time of screening An additional written informed consent will be taken from Parent or legally acceptable representative (as applicable) in case assent is taken from patient aged more than or equal to 6 years and less than 18 years Patient suffering from dry cough associated with sneezing and/or running nose and or throat irritation Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control example combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral injectable or implantable] hormonal contraception associated with inhibition of ovulation intrauterine devices intrauterine hormone releasing system OR bilateral tubal occlusion vasectomized partner or total sexual abstinence).

Exclusion Criteria

Patient with chronic cough that occurs due to smoking, asthma or COPD or any other reasons Patient with clinically significant conditions including but not limited to: pulmonary (e.g. bronchitis, bronchiectasis or asthma), central nervous system (e.g. epilepsy), severe hypertension (seated systolic ≥ 180 mmHg, or seated diastolic ≥ 110 mmHg), glaucoma, ocular hypertension (IOP > 21 mmHg), severe hepatic impairment (Child Pugh Class C) and severe renal impairment (eGFR < 15 ml/min) Patient with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose Malabsorption Patient with history of HIV, Hepatitis B and Hepatitis C Patient used any medication or herbal remedies to treat cold and cough prior to screening (antibiotics in the last 14 days, antitussive or antihistamines or decongestant or herbal remedies in the last 72 hours, medicated lozenge in the last 24 hours) Patient who have used monoamine oxidase inhibitors within 14 days prior to screening Patient with a history of allergic response to any of the investigational product and/or its components Patient with current diagnosis of substance abuse (as per DSM-5) or history of alcohol or drug abuse in the past 3 months prior to screening visit Patient who has participated in another investigational study within 30 days prior to screening of this study or planning to participate during the study Female patient who is pregnant and /or lactating Patient judged unfit for this study by investigator Investigator, study personnel, sponsor representatives and their first degree relatives Patient operating heavy complex machinery or who intend to drive.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessment includes Treatment Emergent Adverse Events (TEAEs) reported during the study	Baseline,Day 7
Change in severity of cough as per cough severity score	Baseline,Day 7

Secondary Outcome Measures

Name	Time	Method
Change in frequency of cough (recorded since last 24 hours) as per Likert scale	Change in severity of sneezing as per Likert scale

Trial Locations

Locations (9)

Apollo Specialty Hospital Pvt. Ltd; 🇮🇳 Nagar, UTTAR PRADESH, India

Citizen Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Grant Medical college; 🇮🇳 Mumbai, MAHARASHTRA, India

Hi tech Multispeciality Hospital; 🇮🇳 Gandhinagar, GUJARAT, India

Jawahar Lal Nehru Medical; 🇮🇳 Ajmer, RAJASTHAN, India

Lotus Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Maharaja Agrasen Superspeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Priyadarshani Nursing Home; 🇮🇳 Mumbai, MAHARASHTRA, India

Sparsh Hospital and Critical Care (P),Ltd; 🇮🇳 Bargarh, ORISSA, India

Apollo Specialty Hospital Pvt. Ltd

🇮🇳Nagar, UTTAR PRADESH, India

Dr Sandeep Katiyar

Principal investigator

9889888080

skkatiyarin@gmail.com