Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the drug combination of Ibuprofen/Loratadine versus Ibuprofen versus Loratadine as monotherapy for the symptomatic treatment of the common cold.
Researchers will compare the fixed-dose combination of Ibuprofen + Loratadine versus Ibuprofen versus Loratadine for the symptomatic treatment of the common cold. The adverse events related to the interventions will be registered during follow up.
In the event that the symptoms worsen or the patient's clinical condition warrants the use of any additional medication, the principal investigator or designated physician will be in charge of prescribing it according to the individual clinical condition and the physical examination, this will be recorded as "Concomitant medication".
Participants will:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen + Loratadine | Experimental | Administered orally (suspension), 5 mL twice a day, for 7 days. |
|
| Ibuprofen | Active Comparator | Administered orally (suspension), 20 mL, twice a day for 7 days. |
|
| Loratadine | Active Comparator | Administered orally (suspension), 5 mL, twice a day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen + Loratadine fixed dose | Drug | Suspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the improvement in symptoms, comparing the percentage change through the Jackson score | The Jackson score is calculated by summing 8 symptom scores (sneezing, headache, malaise, chilliness, nasal discharge, nasal obstruction, sore throat and cough), rated as 0=absent, 1=mild, 2=moderate, and 3=severe. | 7 days |
| Number of participants with treatment-related adverse events through the patient's diary record, by treatment group | To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the subjective change in patients in relation to quality of life through the modified Likert score | To compare quality of life measured as a difference in the modified Likert score by treatment group during the 7 days after starting treatment with respect to the baseline measurement. The patient will answer the scale daily. The Likert Scale is a seven point scale that is used to allow an individual to express how much they agree or disagree with a particular statement. The scale consists of 1 question associated to quality of life. The possible answers go from No interference to Severe interference. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the percentage of patients with febrile episodes (≥38°C) during the intervention | The patient will report the presence of fever during the intervention, quantified with a thermometer. | 7 days |
| To report the percentage of therapeutic adherence at day 7 of intervention by group of treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge A Gonzalez, PhD | Contact | 5254883785 | 3761 | jogonzalez@silanes.com.mx |
| Yulia Romero-Antonio, B.S. | Contact | 5254883785 | 3777 | yromero@silanes.com.mx |
| Name | Affiliation | Role |
|---|---|---|
| Ana Luara Flores-Barranco, MD | Oaxaca Site Management Organization | Principal Investigator |
| Juan A Becerra-Hernández, MD | Centro de Investigación y Avances Médicos Especializados | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio Silanes, S.A. de C.V. | Recruiting | Mexico City | 11000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12517470 | Background | Heikkinen T, Jarvinen A. The common cold. Lancet. 2003 Jan 4;361(9351):51-9. doi: 10.1016/S0140-6736(03)12162-9. | |
| 11512079 | Background | Gonzales R, Malone DC, Maselli JH, Sande MA. Excessive antibiotic use for acute respiratory infections in the United States. Clin Infect Dis. 2001 Sep 15;33(6):757-62. doi: 10.1086/322627. Epub 2001 Aug 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ibuprofen | Drug | Suspension 2,000 mg / 100 mL, 20 mL twice a day |
|
|
| Loratadine | Drug | Suspension 1 mg / 1 mL, 5 mL twice a day |
|
|
| 7 days |
| Assess the subjective change in patients in relation to improvement in symptoms through the Subjective Global Scale | Assess the improvement in symptoms measured as the proportion of patients who present a change in the Global Subjective Scale during the 7 days after starting treatment with respect to the baseline measurement. The subjective global scale for symptom improvement compares with the score of the previous day to determine health status daily. Is consists of 1 question related to the progress in the symptoms presentation, the answers go from much better to really worse. | 7 days |
| Assess the improvement in health status through the modified Likert Scale | To compare improvement in health status as a difference in the modified Likert scale by treatment group during the 7 days after starting treatment with respect to the baseline measurement.The patient will answer the scale daily. The Likert Scale is a seven point scale that is used to allow an individual to express how much they agree or disagree with a particular statement. The scale consists of 1 question associated to the health status of the patient. The possible answers go from Not feeling sick to feeling to Severely sick. | 7 days |
Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation |
| 7 days |
| Salvador Perez-Jaime, MD | CIMA | Principal Investigator |
| Victor C Bohorquez-Lopez, MD | Mérida Investigación ClÃnica | Principal Investigator |
| 8890137 | Background | Kirkpatrick GL. The common cold. Prim Care. 1996 Dec;23(4):657-75. doi: 10.1016/s0095-4543(05)70355-9. |
| 12588210 | Background | Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003 Feb 24;163(4):487-94. doi: 10.1001/archinte.163.4.487. |
| 24415465 | Background | Passioti M, Maggina P, Megremis S, Papadopoulos NG. The common cold: potential for future prevention or cure. Curr Allergy Asthma Rep. 2014 Feb;14(2):413. doi: 10.1007/s11882-013-0413-5. |
| 3039011 | Background | Dick EC, Jennings LC, Mink KA, Wartgow CD, Inhorn SL. Aerosol transmission of rhinovirus colds. J Infect Dis. 1987 Sep;156(3):442-8. doi: 10.1093/infdis/156.3.442. |
| 26608252 | Background | Shaw Stewart PD. Seasonality and selective trends in viral acute respiratory tract infections. Med Hypotheses. 2016 Jan;86:104-19. doi: 10.1016/j.mehy.2015.11.005. Epub 2015 Nov 6. |
| 7713184 | Background | Monto AS. Studies of the community and family: acute respiratory illness and infection. Epidemiol Rev. 1994;16(2):351-73. doi: 10.1093/oxfordjournals.epirev.a036158. |
| 33989481 | Background | Lopez Olmedo N, Stern D, Perez Ferrer C, Gonzalez Morales R, Canto Osorio F, Barrientos Gutierrez T. Revision rapida: probabilidad de contagio por infecciones respiratorias agudas en el transporte publico colectivo. Salud Publica Mex. 2021 Feb 26;63(2, Mar-Abr):225-231. doi: 10.21149/12027. Spanish. |
| 8164529 | Background | Nieman DC. Exercise, upper respiratory tract infection, and the immune system. Med Sci Sports Exerc. 1994 Feb;26(2):128-39. doi: 10.1249/00005768-199402000-00002. |
| 10614857 | Background | Pitkaranta A, Nokso-Koivisto J, Jantti V, Takala A, Kilpi T, Hovi T. Lowered yields of virus-induced interferon production in leukocyte cultures and risk of recurrent respiratory infections in children. J Clin Virol. 1999 Dec;14(3):199-205. doi: 10.1016/s1386-6532(99)00056-6. |
| 9207716 | Background | Turner RB. Epidemiology, pathogenesis, and treatment of the common cold. Ann Allergy Asthma Immunol. 1997 Jun;78(6):531-9; quiz 539-40. doi: 10.1016/S1081-1206(10)63213-9. |
| 16253889 | Background | Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005 Nov;5(11):718-25. doi: 10.1016/S1473-3099(05)70270-X. |
| 4286006 | Background | Douglas RG Jr, Alford RH, Cate TR, Couch RB. The leukocyte response during viral respiratory illness in man. Ann Intern Med. 1966 Mar;64(3):521-30. doi: 10.7326/0003-4819-64-3-521. No abstract available. |
| 32288450 | Background | Hendley JO. Epidemiology, pathogenesis, and treatment of the common cold. Semin Pediatr Infect Dis. 1998 Jan;9(1):50-55. doi: 10.1016/S1045-1870(98)80051-4. Epub 2006 Jun 3. |
| 11068659 | Background | Eccles R. Pathophysiology of nasal symptoms. Am J Rhinol. 2000 Sep-Oct;14(5):335-8. doi: 10.2500/105065800781329528. |
| 3345041 | Background | Proud D, Reynolds CJ, Lacapra S, Kagey-Sobotka A, Lichtenstein LM, Naclerio RM. Nasal provocation with bradykinin induces symptoms of rhinitis and a sore throat. Am Rev Respir Dis. 1988 Mar;137(3):613-6. doi: 10.1164/ajrccm/137.3.613. |
| 14977558 | Background | Conti B, Tabarean I, Andrei C, Bartfai T. Cytokines and fever. Front Biosci. 2004 May 1;9:1433-49. doi: 10.2741/1341. |
| 8394240 | Background | Tyrrell DA, Cohen S, Schlarb JE. Signs and symptoms in common colds. Epidemiol Infect. 1993 Aug;111(1):143-56. doi: 10.1017/s0950268800056764. |
| 13654511 | Background | JACKSON GG, DOWLING HF. Transmission of the common cold to volunteers under controlled conditions. IV. Specific immunity to the common cold. J Clin Invest. 1959 May;38(5):762-9. doi: 10.1172/JCI103857. No abstract available. |
| 8424180 | Background | Macintyre S. Gender differences in the perceptions of common cold symptoms. Soc Sci Med. 1993 Jan;36(1):15-20. doi: 10.1016/0277-9536(93)90301-j. |
| 30689772 | Background | Vos LM, Bruning AHL, Reitsma JB, Schuurman R, Riezebos-Brilman A, Hoepelman AIM, Oosterheert JJ. Rapid Molecular Tests for Influenza, Respiratory Syncytial Virus, and Other Respiratory Viruses: A Systematic Review of Diagnostic Accuracy and Clinical Impact Studies. Clin Infect Dis. 2019 Sep 13;69(7):1243-1253. doi: 10.1093/cid/ciz056. |
| 24567027 | Background | Rhedin S, Lindstrand A, Rotzen-Ostlund M, Tolfvenstam T, Ohrmalm L, Rinder MR, Zweygberg-Wirgart B, Ortqvist A, Henriques-Normark B, Broliden K, Naucler P. Clinical utility of PCR for common viruses in acute respiratory illness. Pediatrics. 2014 Mar;133(3):e538-45. doi: 10.1542/peds.2013-3042. Epub 2014 Feb 24. |
| 11978238 | Background | Barrett B, Locken K, Maberry R, Schwamman J, Brown R, Bobula J, Stauffacher EA. The Wisconsin Upper Respiratory Symptom Survey (WURSS): a new research instrument for assessing the common cold. J Fam Pract. 2002 Mar;51(3):265. |
| 15878475 | Background | Barrett B, Brown R, Mundt M, Safdar N, Dye L, Maberry R, Alt J. The Wisconsin Upper Respiratory Symptom Survey is responsive, reliable, and valid. J Clin Epidemiol. 2005 Jun;58(6):609-17. doi: 10.1016/j.jclinepi.2004.11.019. |
| 19674476 | Background | Barrett B, Brown RL, Mundt MP, Thomas GR, Barlow SK, Highstrom AD, Bahrainian M. Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Health Qual Life Outcomes. 2009 Aug 12;7:76. doi: 10.1186/1477-7525-7-76. |
| 35789217 | Background | Lindberg F, Nelson I, Ranstam J, Riker DK. Early intervention with a glycerol throat spray containing cold-adapted cod trypsin after self-diagnosis of common cold: A randomised trial. PLoS One. 2022 Jul 5;17(7):e0270699. doi: 10.1371/journal.pone.0270699. eCollection 2022. |
| 26438038 | Background | Eccles R, Winther B, Johnston SL, Robinson P, Trampisch M, Koelsch S. Efficacy and safety of iota-carrageenan nasal spray versus placebo in early treatment of the common cold in adults: the ICICC trial. Respir Res. 2015 Oct 5;16:121. doi: 10.1186/s12931-015-0281-8. |
| 16641127 | Background | Barrett B, Brown R, Voland R, Maberry R, Turner R. Relations among questionnaire and laboratory measures of rhinovirus infection. Eur Respir J. 2006 Aug;28(2):358-63. doi: 10.1183/09031936.06.00002606. Epub 2006 Apr 26. |
| 13497324 | Background | JACKSON GG, DOWLING HF, SPIESMAN IG, BOAND AV. Transmission of the common cold to volunteers under controlled conditions. I. The common cold as a clinical entity. AMA Arch Intern Med. 1958 Feb;101(2):267-78. doi: 10.1001/archinte.1958.00260140099015. No abstract available. |
| 14450587 | Background | JACKSON GG, DOWLING HF, MULDOON RL. Acute respiratory diseases of viral etiology. VII. Present concepts of the common cold. Am J Public Health Nations Health. 1962 Jun;52(6):940-5. doi: 10.2105/ajph.52.6.940. No abstract available. |
| 8974108 | Background | Hemila H. Vitamin C supplementation and common cold symptoms: problems with inaccurate reviews. Nutrition. 1996 Nov-Dec;12(11-12):804-9. doi: 10.1016/s0899-9007(96)00223-7. |
| 240145 | Background | West S, Brandon B, Stolley P, Rumrill R. A review of antihistamines and the common cold. Pediatrics. 1975 Jul;56(1):100-7. No abstract available. |
| 26615034 | Background | De Sutter AI, Saraswat A, van Driel ML. Antihistamines for the common cold. Cochrane Database Syst Rev. 2015 Nov 29;2015(11):CD009345. doi: 10.1002/14651858.CD009345.pub2. |
| 26387658 | Background | Kim SY, Chang YJ, Cho HM, Hwang YW, Moon YS. Non-steroidal anti-inflammatory drugs for the common cold. Cochrane Database Syst Rev. 2015 Sep 21;2015(9):CD006362. doi: 10.1002/14651858.CD006362.pub4. |
| 16882099 | Background | Eccles R. Efficacy and safety of over-the-counter analgesics in the treatment of common cold and flu. J Clin Pharm Ther. 2006 Aug;31(4):309-19. doi: 10.1111/j.1365-2710.2006.00754.x. |
| 15992014 | Background | Handley DA, Magnetti A, Higgins AJ. Therapeutic advantages of third generation antihistamines. Expert Opin Investig Drugs. 1998 Jul;7(7):1045-54. doi: 10.1517/13543784.7.7.1045. |
| 2523301 | Background | Clissold SP, Sorkin EM, Goa KL. Loratadine. A preliminary review of its pharmacodynamic properties and therapeutic efficacy. Drugs. 1989 Jan;37(1):42-57. doi: 10.2165/00003495-198937010-00003. |
| 10444229 | Background | Kay GG, Harris AG. Loratadine: a non-sedating antihistamine. Review of its effects on cognition, psychomotor performance, mood and sedation. Clin Exp Allergy. 1999 Jul;29 Suppl 3:147-50. doi: 10.1046/j.1365-2222.1999.0290s3147.x. |
| 2525847 | Background | Barenholtz HA, McLeod DC. Loratadine: a nonsedating antihistamine with once-daily dosing. DICP. 1989 Jun;23(6):445-50. doi: 10.1177/106002808902300601. |
| 7528133 | Background | Haria M, Fitton A, Peters DH. Loratadine. A reappraisal of its pharmacological properties and therapeutic use in allergic disorders. Drugs. 1994 Oct;48(4):617-37. doi: 10.2165/00003495-199448040-00009. |
| 35512063 | Background | Zhang J, Kan D. Evaluation of efficiency and safety of combined loratadine and budesonide in patients with anaphylactic rhinitis: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2022 Apr 29;101(17):e28851. doi: 10.1097/MD.0000000000028851. |
| 18426147 | Background | Anolik R; Mometasone Furoate Nasal Spray With Loratadine Study Group. Clinical benefits of combination treatment with mometasone furoate nasal spray and loratadine vs monotherapy with mometasone furoate in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2008 Mar;100(3):264-71. doi: 10.1016/S1081-1206(10)60452-8. |
| 9722799 | Background | Ratner PH, van Bavel JH, Martin BG, Hampel FC Jr, Howland WC 3rd, Rogenes PR, Westlund RE, Bowers BW, Cook CK. A comparison of the efficacy of fluticasone propionate aqueous nasal spray and loratadine, alone and in combination, for the treatment of seasonal allergic rhinitis. J Fam Pract. 1998 Aug;47(2):118-25. |
| 12086367 | Background | Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600. doi: 10.1016/S1081-1206(10)61891-1. |
| 11994701 | Background | Dahlen B, Roquet A, Inman MD, Karlsson O, Naya I, Anstren G, O'Byrne PM, Dahlen SE. Influence of zafirlukast and loratadine on exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2002 May;109(5):789-93. doi: 10.1067/mai.2002.123306. |
| 11496238 | Background | Papi A, Papadopoulos NG, Stanciu LA, Degitz K, Holgate ST, Johnston SL. Effect of desloratadine and loratadine on rhinovirus-induced intercellular adhesion molecule 1 upregulation and promoter activation in respiratory epithelial cells. J Allergy Clin Immunol. 2001 Aug;108(2):221-8. doi: 10.1067/mai.2001.116861. |
| 2529799 | Background | Berkowitz RB, Connell JT, Dietz AJ, Greenstein SM, Tinkelman DG. The effectiveness of the nonsedating antihistamine loratadine plus pseudoephedrine in the symptomatic management of the common cold. Ann Allergy. 1989 Oct;63(4):336-9. |
| 28005035 | Background | Trukhan DI, Mazurov AL, Rechapova LA. [Acute respiratory viral infections: Topical issues of diagnosis, prevention and treatment in therapeutic practice]. Ter Arkh. 2016;88(11):76-82. doi: 10.17116/terarkh2016881176-82. Russian. |
| 12852704 | Background | Chavez ML, DeKorte CJ. Valdecoxib: a review. Clin Ther. 2003 Mar;25(3):817-51. doi: 10.1016/s0149-2918(03)80110-8. |
| 16380350 | Background | Wahbi AA, Hassan E, Hamdy D, Khamis E, Barary M. Spectrophotometric methods for the determination of Ibuprofen in tablets. Pak J Pharm Sci. 2005 Oct;18(4):1-6. |
| 16136567 | Background | Potthast H, Dressman JB, Junginger HE, Midha KK, Oeser H, Shah VP, Vogelpoel H, Barends DM. Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen. J Pharm Sci. 2005 Oct;94(10):2121-31. doi: 10.1002/jps.20444. |
| 31705437 | Background | Varrassi G, Pergolizzi JV, Dowling P, Paladini A. Ibuprofen Safety at the Golden Anniversary: Are all NSAIDs the Same? A Narrative Review. Adv Ther. 2020 Jan;37(1):61-82. doi: 10.1007/s12325-019-01144-9. Epub 2019 Nov 8. |
| 22043330 | Background | Bushra R, Aslam N. An overview of clinical pharmacology of Ibuprofen. Oman Med J. 2010 Jul;25(3):155-1661. doi: 10.5001/omj.2010.49. |
| 31984540 | Background | Zoubek ME, Lucena MI, Andrade RJ, Stephens C. Systematic review: ibuprofen-induced liver injury. Aliment Pharmacol Ther. 2020 Mar;51(6):603-611. doi: 10.1111/apt.15645. Epub 2020 Jan 27. |
| 11704782 | Background | Barkin RL. Acetaminophen, aspirin, or Ibuprofen in combination analgesic products. Am J Ther. 2001 Nov-Dec;8(6):433-42. doi: 10.1097/00045391-200111000-00008. |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D003533 |
| Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |