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Last Updated: August 7, 2020

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CLINICAL TRIALS PROFILE FOR AMBROXOL

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Clinical Trials for Ambroxol

Trial ID Title Status Sponsor Phase Summary
NCT00144274 Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis Completed Boehringer Ingelheim Phase 3 The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suf fering from acute viral pharyngitis. The primary endpoint is the time-weighted average of the pain intensity difference from pre-dose bas eline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline ( SPIDnorm).
NCT00148499 Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis Completed Boehringer Ingelheim Phase 3 The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20 mg a mbroxol hydrochloride (Mucoangin?) relative to lozenges containing placebo and lozenges containing 3 mg benzocaine in relieving pain of sore throat in patients suffering from acute viral pharyngitis.
NCT00525044 Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat Completed Boehringer Ingelheim Phase 3 The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.
NCT01361802 Ambroxol Spray Sore Throat Study Completed Boehringer Ingelheim Phase 2 The development of a new Ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase II study to be conducted in order to select the most appropriate dose for pain relief.
NCT01463215 Clinical Trial of Ambroxol in Patients With Type I Gaucher Disease Suspended Exsar Corporation Phase 1/Phase 2 Ambroxol is expected to improve the signs and symptoms of patients with Type I Gaucher Disease.
NCT01573663 A Drug-Drug Interaction Study of Ambroxol and Levodropropizine Completed Hanmi Pharmaceutical Company Limited Phase 1 The purpose of this study is to evaluate the drug-durg interaction between ambroxol and levodropropizine.
NCT01713179 Effects of Oral Mucolytics on Tear Film and Ocular Surface Completed Hallym University Kangnam Sacred Heart Hospital Phase 1/Phase 2 Ambroxol is a metabolite of bromhexine and possesses mucokinetic and secretolytic properties that are also found in mucolytic agents.1 Ambroxol has been used for decades for the treatment of respiratory disorders associated with excessive mucus, including chronic inflammatory pulmonary conditions, bronchitis, and pneumonia.2,3 The drug changes the biophysical properties of secretions by degrading the mucin polymers, deoxyribonucleic acid, fibrin in airway secretions, and by generally decreasing viscosity.4 In addition, ambroxol increases cyclic nucleotide (cAMP or cGMP),5 which can theoretically increase tear secretion.6 Many systemic medications, such as antihistamines, antidepressants, diuretics, acne drugs, and certain blood pressure medicines can cause or exacerbate a dry eye.7,8 On the other hand, several topical medications, including mucolytics such as ambroxol and bromhexine, may be used to treat tear-deficient dry eyes by promoting lacrimal gland function.9 However, the effects of mucoactive agents on the tear film have not been investigated systemically, and mucoactive agents may have a disturbing effect on the tear film because they modify mucin.10,11 The tear film is composed of 3 unique layers, including the outermost lipid layer, the middle aqueous layer, and the innermost mucus layer; this structure enables it to perform many functions.12 The lipid layer acts as a barrier to prevent tear film evaporation, and the aqueous layer supplies oxygen and important nutrients to the cornea.13 The mucin layer, secreted mostly by conjunctival goblet cells, coats the corneal surface rendering it hydrophilic, and anchors the tear film to the corneal surface.14 Deficiencies in the amount of tear production or alteration in tear composition can lead to ocular surface disease.15 Although many studies have focused on aqueous-deficient dry eye syndrome,16-18 the effect of mucin layer defects on the tear film has not been thoroughly studied. Furthermore, very few reports have determined the effects of oral mucolytic agents on the tear film and ocular surfaces, although a study has reported that filamentary keratopathy was treated with debridement of filaments and application of topical mucolytic agents such as acetylcysteine eyedrops. In the present study, we investigated the effects of oral ambroxol on tear film and ocular surface. Reference 1. Malerba M, Ragnoli B. Ambroxol in the 21st century: pharmacological and clinical update. Expert Opin Drug Metab Toxicol 2008;4:1119-1129. 2. Rubin BK. Mucolytics, expectorants, and mucokinetic medications. Respir Care 2007;52:859-865. 3. Rogers DF. Mucoactive agents for airway mucus hypersecretory diseases. Respir Care 2007;52:1176-1193. 4. Gupta PR. Ambroxol - Resurgence of an old molecule as an anti-inflammatory agent in chronic obstructive airway diseases. Lung India 2010;27:46-48. 5. Anfossi G, Russo I, Massucco P, et al. Adenosine increase human platelet levels of cGMP through nitric oxide: possible role in its antiaggregating effect. Thromb Res 2002;105:71-78. 6. Gilbard JP, Rossi SR, Heyda KG, et al. Stimulation of tear secretion by topical agents that increase cyclic nucleotide levels. Invest Ophthalmol Vis Sci 1990;31:1381-1388. 7. Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol 2009;3:405-412. 8. Terry MA. Dry eye in the elderly. Drugs Aging 2001;18:101-107. 9. Calonge M. The treatment of dry eye. Surv Ophthalmol 2001;45:227-239. 10. Yamada T, Takemura Y, Niisato N, et al. Action of N-acylated ambroxol derivatives on secretion of chloride ions in human airway epithelia. Biochem Biophys Res Commun 2009;380:586-590. 11. Hasegawa I, Niisato N, Iwasaki Y, et al. Ambroxol-induced modification of ion transport in human airway Calu-3 epithelia. Biochem Biophys Res Commun 2006;343:475-482. 12. Antti H, Tuulikki S, Matej O. Human tear fluid lipidome: from composition to function. PLoS One 2011;6:e19553. 13. Ohashi Y, Dogru M, Tsubota K. Laboratory findings in tear fluid analysis. Clin Chim Acta 2006;396:17-28. 14. Davidson HJ, Kuonen VJ. The tear film and ocular mucins. Vet Ophthalmol 2004;7:71-77. 15. Bhavsar AS, Bhavsar SG, Jain SM. A review on recent advances in dry eye: pathogenesis and management. Oman J Ophthalmol 2011;4:50-56. 16. Patel S, Farrell J, Blades KJ, et al. The value of a phenol red impregnated thread for differentiating between the aqueous and non-aqueous deficient dry eye. Ophthalmic Physiol Opt 1998;18:471-476. 17. Lin H, Li W, Dong N, et al. Changes in corneal epithelial layer inflammatory cells in aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2010;51:122-128. 18. Yokoi N, Yamada H, Mizukusa Y, et al. Rheology of tear film lipid layer spread in normal and aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2008;49:5319-5324.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Ambroxol

Condition Name

Condition Name for
Intervention Trials
Healthy 7
Pharyngitis 5
Healthy Volunteers 1
Healthy Male 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Pharyngitis 5
Parkinson Disease 2
Dementia 2
Gaucher Disease 2
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Clinical Trial Locations for Ambroxol

Trials by Country

Trials by Country for
Location Trials
South Africa 3
United Kingdom 2
Korea, Republic of 2
Romania 1
United States 1
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Trials by US State

Trials by US State for
Location Trials
New Jersey 1
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Clinical Trial Progress for Ambroxol

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 6
Phase 2 5
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 15
Not yet recruiting 5
Recruiting 2
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Clinical Trial Sponsors for Ambroxol

Sponsor Name

Sponsor Name for
Sponsor Trials
Boehringer Ingelheim 10
Lawson Health Research Institute 2
Sanofi 2
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 17
Other 12
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