Effect of FDC syrup of Bilastine/Dextromethorphan/ Phenylephrine in patients with cough with common cold or allergy.

Phase 3

Completed

• Conditions: Respiratory disorder, unspecified,

• Registration Number: CTRI/2023/09/057263
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

Thisis a Multi-center, randomized, parallel group, active-controlled, open labelclinical trial to evaluate efficacy and safety of fixed dose combination syrupof Bilastine 3.3 mg, Dextromethorphan 10 mg and Phenylephrine 5 mg per 5 mL, inpatients with cough associated with common cold or allergy

Themaximum total duration of study is of 8 days which consisted of 7 treatmentdays.

The primary outcomemeasures consist of change from baseline in cough severity on 100mm VAS atDay 4.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-04-10
• Study Start: 2023-09-15
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• 1.Age at least 12 years (completed) and less than 65 years (subjects who completed 65th birthday will be excluded) at the time of signing consent/assent.
• 2.Provided written informed consent (pediatric assent and parental consent in case of children < 18 years of age).
• 3.Male or female subjects with acute cough of less than 7 days duration at the time of consent, associated with common cold or allergy.
• 4.Cough severity at least 60 mm on visual analogue scale (VAS) at screening.
• 5.Willing and able to comply with all aspects of the protocol.
• 6.For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pre-treatment urine pregnancy test 7.Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.

Exclusion Criteria

• 1.A productive cough with excessive secretions, regardless of colour.
• 2.Subjects with chronic cough (i.e. history of chronic bronchitis in smokers, gastroâ€esophageal reflux, asthma, hyperâ€responsive airways after resolution of respiratory tract infection, COPD, pertussis, aspiration, tumor, tuberculosis or fungal infections).
• 3.Subjects receiving oral or intranasal anti-histamine or cough suppressant or decongestant within 7 days prior to screening.
• 4.Subjects taking angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) within 14 days of consent 5.Pregnant or breastfeeding.
• 6.Positive urine pregnancy test at screening.
• 7.Known hypersensitivity to the study drugs (investigational product or comparator) or any of the excipients.
• 8.Subjects with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the subject’s participation in the study.
• 9.Previous participation in another interventional clinical study within 30 days of first dose in this study.
• 10.Concurrent enrolment in another interventional clinical study.
• 11.Employee of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
• 12.Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
• 13.Subjects with history of significant cardiovascular disease, uncontrolled hypertension, uncontrolled diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement or phaeochromocytoma at screening.
• Subjects receiving monoamine oxidase inhibitor, a selective serotonin reuptake inhibitor, or other medications for depression, psychiatric, or emotional conditions, or Parkinson s disease with within 14 days prior to consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to Day 4 in cough severity on a 100 mm Visual Analogue Scale (VAS)	From baseline to Day 4

Secondary Outcome Measures

Name	Time	Method
Drowsiness score on Profile of Mood State (POMS) questionnaire	From Baseline to end of study
Change from baseline to Day 8 in cough severity on a 100 mm VAS	From baseline to Day 8
Proportion of subjects with resolution of cough symptoms on Day 4 and 8	On Day 4 and Day 8
Proportion of subjects with complete clinical cure on Day 4 and 8	On Day 4 and Day 8
Patient Global Impression of Change (PGIC) on Day 4 and 8	On Day 4 and Day 8
Investigator Global Impression of Change (IGIC) on Day 4 and 8	On Day 4 and Day 8
Change from baseline to Day 4 and 8 in cough frequency on a 100 mm VAS	From Baseline to Day 4 and Day 8
Change from baseline to Day 4and 8 in sleep deprivation on a 100 mm VAS	From Baseline to Day 4 and Day 8
Adverse events	From the start to end of study

Trial Locations

Locations (10)

All India Institute of Medical Sciences; 🇮🇳 Nagpur, MAHARASHTRA, India

Assured Care Plus Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Lata Mangeshkar Multispeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Lifepoint Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

M. V. Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Pulse Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Renova Neelima Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Sri Siddhivinayak Maternity and Nursing Home; 🇮🇳 Nashik, MAHARASHTRA, India

Suyash Hospital; 🇮🇳 Raipur, CHHATTISGARH, India

Victoria Hospital, Bangalore Medical College and Research Institute; 🇮🇳 Bangalore, KARNATAKA, India

All India Institute of Medical Sciences

🇮🇳Nagpur, MAHARASHTRA, India

Dr Ganesh Natthuji Dakhale

Principal investigator

9850539353

gndakhle@rediffmail.com