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| Name | Class |
|---|---|
| Econometrica, Inc. | INDUSTRY |
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Upper respiratory infections (URIs) have long posed a significant burden to the US healthcare system. Well before the coronavirus disease of 2019 (COVID-19) pandemic they have been among the most common acute outpatient illnesses, causing 75-100 million physician visits each year on average, and costing the health care system billions of dollars annually. This double-blind randomized placebo-controlled study tested the efficacy of two anti-inflammatory throat sprays against placebo and against a throat spray taken in conjunction with 325mg of aspirin, a well-known systemically administered cyclooxygenase (COX) inhibitor. Participants having common cold symptoms lasting less than two days were enrolled and given treatment to administer at home. Various common cold symptoms were assessed and measured via clinically validated self-assessment scales. Participants were screened for influenza and COVID-19 before enrollment and were excluded if found positive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Placebo Throat Spray and Placebo Tablet | Placebo Comparator | The placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener. Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. |
|
| Group B: Wintergreen Throat Spray and Aspirin Tablet | Active Comparator | The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Aspirin in a 325mg tablet |
|
| Group C: Aspirin Throat Spray and Placebo Tablet | Active Comparator | The liquid spray contained 6mg dissolved acetyl salicylic acid per dose, menthol, lactoferrin, lysozyme, aloe, and glycerin. Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. |
|
| Group D: Wintergreen Throat Spray and Placebo Tablet | Active Comparator | The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wintergreen Throat Spray and Aspirin Tablet | Drug | The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Aspirin in a 325mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief of Sore Throat Pain | A time-weighted summed difference in pain intensity on the sore throat pain intensity scale (STPIS) after the first dose of medication (STPIS 1st entry Day 1 compared to STPIS 4th entry Day 2). On the STPIS, 0mm, the leftmost point of the line, represents no throat pain, and 100mm, the rightmost point of the line, represents the most severe throat pain. | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Efficacy Against Common Cold Symptoms | Secondary endpoints will include changes to the Modified Jackson Score, measured from Absent=0, Mild=1, Moderate=2 to Severe=3, with a higher score representing worsening of various cold symptoms and a lower score signifying improvement of various cold symptoms. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nazlie Latefi, PhD | Applied Biological Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Telemedicine and Home Visit | Irvine | California | 92614-0120 | United States | ||
| Telemedicine and Home Visit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23091044 | Background | Shulman ST, Bisno AL, Clegg HW, Gerber MA, Kaplan EL, Lee G, Martin JM, Van Beneden C. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis. 2012 Nov 15;55(10):1279-82. doi: 10.1093/cid/cis847. | |
| 26387658 | Background |
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Will be determined as needed, if shared no identifiable personal information will be provided.
Will be determined as needed
Requesting researchers will only receive the participant's code number, age, sex, ethnicity, but no other identifying information.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2022 |
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|
| Aspirin Throat Spray and Placebo Tablet | Drug | The liquid spray contained 6mg dissolved acetyl salicylic acid per dose, menthol, lactoferrin, lysozyme, aloe, and glycerin. Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients. |
|
|
| Wintergreen Throat Spray and Placebo Tablet | Dietary Supplement | The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients. |
|
|
| Placebo Throat Spray and Placebo Tablet | Other | The placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener. The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients. |
|
|
| Washington D.C. |
| District of Columbia |
| 20016 |
| United States |
| Telemedicine and Home Visit | Atlanta | Georgia | 30002-0082 | United States |
| Telemedicine and Home Visit | Baltimore | Maryland | 21215 | United States |
| Telemedicine and Home Visit | New York | New York | 11385 | United States |
| Telemedicine and Home Visit | Houston | Texas | 77054-3036 | United States |
| 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. |
| 3018306 | Background | Winther B, Gwaltney JM Jr, Mygind N, Turner RB, Hendley JO. Sites of rhinovirus recovery after point inoculation of the upper airway. JAMA. 1986 Oct 3;256(13):1763-7. |
| 8073865 | Background | Rees GL, Eccles R. Sore throat following nasal and oropharyngeal bradykinin challenge. Acta Otolaryngol. 1994 May;114(3):311-4. doi: 10.3109/00016489409126062. |
| 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. |
| 2262647 | Background | Doyle WJ, Boehm S, Skoner DP. Physiologic responses to intranasal dose-response challenges with histamine, methacholine, bradykinin, and prostaglandin in adult volunteers with and without nasal allergy. J Allergy Clin Immunol. 1990 Dec;86(6 Pt 1):924-35. doi: 10.1016/s0091-6749(05)80156-3. |
| 23533982 | Background | Gupta U, Verma M. Placebo in clinical trials. Perspect Clin Res. 2013 Jan;4(1):49-52. doi: 10.4103/2229-3485.106383. No abstract available. |
| 24988909 | Background | Schachtel B, Aspley S, Shephard A, Shea T, Smith G, Schachtel E. Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study. Trials. 2014 Jul 3;15:263. doi: 10.1186/1745-6215-15-263. |
| 27542891 | Background | Glatthaar-Saalmuller B, Mair KH, Saalmuller A. Antiviral activity of aspirin against RNA viruses of the respiratory tract-an in vitro study. Influenza Other Respir Viruses. 2017 Jan;11(1):85-92. doi: 10.1111/irv.12421. Epub 2016 Sep 22. |
| 12873261 | Background | Eccles R, Loose I, Jawad M, Nyman L. Effects of acetylsalicylic acid on sore throat pain and other pain symptoms associated with acute upper respiratory tract infection. Pain Med. 2003 Jun;4(2):118-24. doi: 10.1046/j.1526-4637.2003.03019.x. |
| 34153179 | Background | Leyva-Grado V, Pugach P, Sadeghi-Latefi N. A novel anti-inflammatory treatment for bradykinin-induced sore throat or pharyngitis. Immun Inflamm Dis. 2021 Dec;9(4):1321-1335. doi: 10.1002/iid3.479. Epub 2021 Jun 21. |
| 39602479 | Derived | Pugach P, Sadeghi-Latefi N. Supporting respiratory epithelia and lowering inflammation to effectively treat common cold symptoms: A randomized controlled trial. PLoS One. 2024 Nov 27;19(11):e0301959. doi: 10.1371/journal.pone.0301959. eCollection 2024. |
| Jan 12, 2024 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D010612 | Pharyngitis |
| D005334 | Fever |
| D000086722 | Rhinorrhea |
| D003371 | Cough |
| D006261 | Headache |
| D012912 | Sneezing |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012120 | Respiration Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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