Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study

Amit Garg; Bharath Venkata Ramisetty; Nirmal Choraria; Kirti Sisodiya; Monidipa Banerjee; Shyam Akku

doi:doi:10.11648/j.ajim.20170506.14

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Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study

Amit Garg, Bharath Venkata Ramisetty, Nirmal Choraria, Kirti Sisodiya, Monidipa Banerjee, Shyam Akku

Published in American Journal of Internal Medicine (Volume 5, Issue 6)

Received: 28 January 2017 Accepted: 14 February 2017 Published: 28 November 2017

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Abstract

Productive cough is a common problem in children and is accompanied by disruption of sleep and routine daily activities leading to a deterioration in quality of life. We evaluated the efficacy, safety and tolerability of cetirizine and ambroxol fixed dose combination (FDC) as compared with ambroxol in these patients. We conducted open-label, prospective, multicenter study attending outpatient department with cough ≥12 hours; were screened to receive either cetirizine and ambroxol FDC (AC group) or ambroxol alone (AX group). Primary efficacy variables were evaluation of total symptom score (TSS) for cough and secondary efficacy variables included evaluation of total nasal symptom score (TNSS); assessment of cough frequency; number of awakenings due to cough; and time to complete relief. Out of 250 children included, 246 completed the study with a statistically significant improvement in TSS from baseline to day 3 (p=0.029) and day 7 (p=0.048) in the AC group as compared with AX group. Improvement in TNSS was better in the AC group from baseline to day 3 (p<0.0001) and day 7 (p=0.016) as compared with the AX group. Greater proportion of children in the AC group recovered completely from cough by day 7 (97.67%) as compared with the AX group (78.63%). As side effects, only two children of the AC group experienced mild AEs (drowsiness). We thus conclude that FDC demonstrated improved efficacy and safety and was well tolerated as compared with ambroxol alone in children with productive cough.

Published in	American Journal of Internal Medicine (Volume 5, Issue 6)
DOI	10.11648/j.ajim.20170506.14
Page(s)	129-135
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2017. Published by Science Publishing Group

Keywords

Cetirizine, Ambroxol, Productive Cough, Children, Total Symptom Score

References

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APA Style

Amit Garg, Bharath Venkata Ramisetty, Nirmal Choraria, Kirti Sisodiya, Monidipa Banerjee, et al. (2017). Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study. American Journal of Internal Medicine, 5(6), 129-135. https://doi.org/10.11648/j.ajim.20170506.14

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ACS Style

Amit Garg; Bharath Venkata Ramisetty; Nirmal Choraria; Kirti Sisodiya; Monidipa Banerjee, et al. Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study. Am. J. Intern. Med. 2017, 5(6), 129-135. doi: 10.11648/j.ajim.20170506.14

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AMA Style

Amit Garg, Bharath Venkata Ramisetty, Nirmal Choraria, Kirti Sisodiya, Monidipa Banerjee, et al. Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study. Am J Intern Med. 2017;5(6):129-135. doi: 10.11648/j.ajim.20170506.14

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@article{10.11648/j.ajim.20170506.14,
  author = {Amit Garg and Bharath Venkata Ramisetty and Nirmal Choraria and Kirti Sisodiya and Monidipa Banerjee and Shyam Akku},
  title = {Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study},
  journal = {American Journal of Internal Medicine},
  volume = {5},
  number = {6},
  pages = {129-135},
  doi = {10.11648/j.ajim.20170506.14},
  url = {https://doi.org/10.11648/j.ajim.20170506.14},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajim.20170506.14},
  abstract = {Productive cough is a common problem in children and is accompanied by disruption of sleep and routine daily activities leading to a deterioration in quality of life. We evaluated the efficacy, safety and tolerability of cetirizine and ambroxol fixed dose combination (FDC) as compared with ambroxol in these patients. We conducted open-label, prospective, multicenter study attending outpatient department with cough ≥12 hours; were screened to receive either cetirizine and ambroxol FDC (AC group) or ambroxol alone (AX group). Primary efficacy variables were evaluation of total symptom score (TSS) for cough and secondary efficacy variables included evaluation of total nasal symptom score (TNSS); assessment of cough frequency; number of awakenings due to cough; and time to complete relief. Out of 250 children included, 246 completed the study with a statistically significant improvement in TSS from baseline to day 3 (p=0.029) and day 7 (p=0.048) in the AC group as compared with AX group. Improvement in TNSS was better in the AC group from baseline to day 3 (pp=0.016) as compared with the AX group. Greater proportion of children in the AC group recovered completely from cough by day 7 (97.67%) as compared with the AX group (78.63%). As side effects, only two children of the AC group experienced mild AEs (drowsiness). We thus conclude that FDC demonstrated improved efficacy and safety and was well tolerated as compared with ambroxol alone in children with productive cough.},
 year = {2017}
}

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TY  - JOUR
T1  - Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study
AU  - Amit Garg
AU  - Bharath Venkata Ramisetty
AU  - Nirmal Choraria
AU  - Kirti Sisodiya
AU  - Monidipa Banerjee
AU  - Shyam Akku
Y1  - 2017/11/28
PY  - 2017
N1  - https://doi.org/10.11648/j.ajim.20170506.14
DO  - 10.11648/j.ajim.20170506.14
T2  - American Journal of Internal Medicine
JF  - American Journal of Internal Medicine
JO  - American Journal of Internal Medicine
SP  - 129
EP  - 135
PB  - Science Publishing Group
SN  - 2330-4324
UR  - https://doi.org/10.11648/j.ajim.20170506.14
AB  - Productive cough is a common problem in children and is accompanied by disruption of sleep and routine daily activities leading to a deterioration in quality of life. We evaluated the efficacy, safety and tolerability of cetirizine and ambroxol fixed dose combination (FDC) as compared with ambroxol in these patients. We conducted open-label, prospective, multicenter study attending outpatient department with cough ≥12 hours; were screened to receive either cetirizine and ambroxol FDC (AC group) or ambroxol alone (AX group). Primary efficacy variables were evaluation of total symptom score (TSS) for cough and secondary efficacy variables included evaluation of total nasal symptom score (TNSS); assessment of cough frequency; number of awakenings due to cough; and time to complete relief. Out of 250 children included, 246 completed the study with a statistically significant improvement in TSS from baseline to day 3 (p=0.029) and day 7 (p=0.048) in the AC group as compared with AX group. Improvement in TNSS was better in the AC group from baseline to day 3 (pp=0.016) as compared with the AX group. Greater proportion of children in the AC group recovered completely from cough by day 7 (97.67%) as compared with the AX group (78.63%). As side effects, only two children of the AC group experienced mild AEs (drowsiness). We thus conclude that FDC demonstrated improved efficacy and safety and was well tolerated as compared with ambroxol alone in children with productive cough.
VL  - 5
IS  - 6
ER  -

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Author Information

Amit Garg

Global Medical Affairs, Dr. Reddy’s Laboratories, Banjara Hills, Hyderabad, India
Bharath Venkata Ramisetty

Narayana Medical College and Hospital, Opposite Narayana Engineering College, Chinthareddypalem, Nellore, India
Nirmal Choraria

Nirmal Hospital, Centre Point, Near Kadiwala School, Surat, India
Kirti Sisodiya

BAPS Hospital, Shri Pramukh Swami Maharaj Marg, Adajan Char Rasta, Adajan, Surat, India
Monidipa Banerjee

Peerless Hospital &`B.K. Roy Research Center360 Panchasayar, Kolkata, India
Shyam Akku

Global Medical Affairs, Dr. Reddy’s Laboratories, Banjara Hills, Hyderabad, India

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APA Style

Amit Garg, Bharath Venkata Ramisetty, Nirmal Choraria, Kirti Sisodiya, Monidipa Banerjee, et al. (2017). Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study. American Journal of Internal Medicine, 5(6), 129-135. https://doi.org/10.11648/j.ajim.20170506.14

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ACS Style

Amit Garg; Bharath Venkata Ramisetty; Nirmal Choraria; Kirti Sisodiya; Monidipa Banerjee, et al. Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study. Am. J. Intern. Med. 2017, 5(6), 129-135. doi: 10.11648/j.ajim.20170506.14

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AMA Style

Amit Garg, Bharath Venkata Ramisetty, Nirmal Choraria, Kirti Sisodiya, Monidipa Banerjee, et al. Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study. Am J Intern Med. 2017;5(6):129-135. doi: 10.11648/j.ajim.20170506.14

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@article{10.11648/j.ajim.20170506.14,
  author = {Amit Garg and Bharath Venkata Ramisetty and Nirmal Choraria and Kirti Sisodiya and Monidipa Banerjee and Shyam Akku},
  title = {Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study},
  journal = {American Journal of Internal Medicine},
  volume = {5},
  number = {6},
  pages = {129-135},
  doi = {10.11648/j.ajim.20170506.14},
  url = {https://doi.org/10.11648/j.ajim.20170506.14},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajim.20170506.14},
  abstract = {Productive cough is a common problem in children and is accompanied by disruption of sleep and routine daily activities leading to a deterioration in quality of life. We evaluated the efficacy, safety and tolerability of cetirizine and ambroxol fixed dose combination (FDC) as compared with ambroxol in these patients. We conducted open-label, prospective, multicenter study attending outpatient department with cough ≥12 hours; were screened to receive either cetirizine and ambroxol FDC (AC group) or ambroxol alone (AX group). Primary efficacy variables were evaluation of total symptom score (TSS) for cough and secondary efficacy variables included evaluation of total nasal symptom score (TNSS); assessment of cough frequency; number of awakenings due to cough; and time to complete relief. Out of 250 children included, 246 completed the study with a statistically significant improvement in TSS from baseline to day 3 (p=0.029) and day 7 (p=0.048) in the AC group as compared with AX group. Improvement in TNSS was better in the AC group from baseline to day 3 (pp=0.016) as compared with the AX group. Greater proportion of children in the AC group recovered completely from cough by day 7 (97.67%) as compared with the AX group (78.63%). As side effects, only two children of the AC group experienced mild AEs (drowsiness). We thus conclude that FDC demonstrated improved efficacy and safety and was well tolerated as compared with ambroxol alone in children with productive cough.},
 year = {2017}
}

Copy | Download

TY  - JOUR
T1  - Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study
AU  - Amit Garg
AU  - Bharath Venkata Ramisetty
AU  - Nirmal Choraria
AU  - Kirti Sisodiya
AU  - Monidipa Banerjee
AU  - Shyam Akku
Y1  - 2017/11/28
PY  - 2017
N1  - https://doi.org/10.11648/j.ajim.20170506.14
DO  - 10.11648/j.ajim.20170506.14
T2  - American Journal of Internal Medicine
JF  - American Journal of Internal Medicine
JO  - American Journal of Internal Medicine
SP  - 129
EP  - 135
PB  - Science Publishing Group
SN  - 2330-4324
UR  - https://doi.org/10.11648/j.ajim.20170506.14
AB  - Productive cough is a common problem in children and is accompanied by disruption of sleep and routine daily activities leading to a deterioration in quality of life. We evaluated the efficacy, safety and tolerability of cetirizine and ambroxol fixed dose combination (FDC) as compared with ambroxol in these patients. We conducted open-label, prospective, multicenter study attending outpatient department with cough ≥12 hours; were screened to receive either cetirizine and ambroxol FDC (AC group) or ambroxol alone (AX group). Primary efficacy variables were evaluation of total symptom score (TSS) for cough and secondary efficacy variables included evaluation of total nasal symptom score (TNSS); assessment of cough frequency; number of awakenings due to cough; and time to complete relief. Out of 250 children included, 246 completed the study with a statistically significant improvement in TSS from baseline to day 3 (p=0.029) and day 7 (p=0.048) in the AC group as compared with AX group. Improvement in TNSS was better in the AC group from baseline to day 3 (pp=0.016) as compared with the AX group. Greater proportion of children in the AC group recovered completely from cough by day 7 (97.67%) as compared with the AX group (78.63%). As side effects, only two children of the AC group experienced mild AEs (drowsiness). We thus conclude that FDC demonstrated improved efficacy and safety and was well tolerated as compared with ambroxol alone in children with productive cough.
VL  - 5
IS  - 6
ER  -

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