Evaluation of the safety and efficacy of codeine phosphate and chlorpheniramine maleate in a fixed dose composition for the management of dry cough in adults: an open label phase IV clinical trial
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20222982Keywords:
Codeine phosphate, Chlorpheniramine maleate, Dry cough, Fixed-dose compositionAbstract
Background: Dry cough is one of the most common symptoms for which patients seek medical attention. It not only causes discomfort in patients, but also hampers their daily work and routine. Since there is no specific underlying cause for dry cough, a definitive treatment is still not available. Several cough suppressants have been used for the treatment of dry cough including codeine which reduces discomfort. However, some reports suggest that use of codeine at high doses leads to sedation and drowsiness. To evaluate the safety and efficacy of codeine, a clinical trial for fixed dose composition of codeine phosphate and chlorpheniramine maleate was conducted.
Methods: The trial was conducted on 219 adults with prior symptoms of dry cough. Safety was evaluated on the basis of the change in patient’s vital parameters, any adverse event or severe adverse event that occurred during the course of study. Efficacy was assessed on the basis of cough severity scores, number of night awakenings due to cough, and overall decline in cough.
Results: According to the investigator's evaluation the product was safe to use as no significant changes in the patient’s vital parameters were observed during the course of study. Also, no severe adverse events were reported. Administration of the investigation product significantly decreased cough severity and frequency at the 7th day of the study.
Conclusions: This study suggests, FDC of codeine phosphate 10 mg and chlorpheniramine maleate 4 mg per 5 ml oral syrup is safe and efficacious for the treatment of dry cough.
Metrics
References
Fuller R, Jackson D. Physiology and treatment of cough. Thorax. 1990;45(6):425.
Irwin RS, Madison JM. The diagnosis and treatment of cough. N Engl J Med. 2000;343(23):1715-21.
Bramley TJ, Lerner D, Sarnes M. Productivity losses related to the common cold. J Occup Env Med. 2002;822-9.
Jain N, Lodha R, Kabra S. Upper respiratory tract infections. Indian J Pediatrics. 2001;68(12):1135-8.
Mäkelä MJ, Puhakka T, Ruuskanen O, Leinonen M, Saikku P, Kimpimäki M, et al. Viruses and bacteria in the etiology of the common cold. J Clin Microbiol. 1998;36(2):539-42.
Heikkinen T, Järvinen A. The common cold. The Lancet. 2003;361(9351):51-9.
Boujaoude ZC, Pratter MR. Clinical approach to acute cough. Lung. 2010;188(1):41-6.
Smith PK. Rhinitis and cough, Rhinitis and Related Upper Respiratory Conditions. Springer. 2018;93-105.
Irwin RS, Curley FJ. The treatment of cough: a comprehensive review. Chest. 1991;99(6):1477-84.
Chung K. Drugs to suppress cough. Exp Opinion Investig Drugs. 2005;14(1):19-27.
Eccles R. Codeine, cough and upper respiratory infection. Pulmonary Pharmacol. 199;9(5-6):293-7.
Bhandari M, Bhandari A, Bhandari A. Recent updates on codeine. Pharmaceutical Methods. 2011;2(1):3-8.
Bolser DC, Davenport PW. Codeine and cough: an ineffective gold standard. Curr Opinion Allergy Clin Immunol. 2007;7(1):32.
Dickinson RS, Morjaria JB, Wright CE, Morice AH. Is opiate action in cough due to sedation? Therapeutic advances in chronic disease. 2014;5(5):200-5.
Padma L. Current drugs for the treatment of dry cough. J Assoc Physicians India. 2013;61(5):9-13.
Blasio FD, Virchow JC, Polverino M, Zanasi A, Behrakis PK, Kilinç G, et al. Lanata, Cough management: a practical approach. Cough. 2011;7(1):1-12.
Eddy NB. Codeine and its alternates for pain and cough relief. Am Coll Physicians. 1969;1209-12.
