Treatment Trials

35 Clinical Trials for Various Conditions

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Alleviation of Common Cold Symptoms
Description

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.

Conditions

Common Cold, Pharyngitis, Fever, Congestion, Rhinorrhea, Cough, Sore-throat, Sore Throats Viral, Malaise, Headache, Runny Nose, Sneezing

To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold
Description

This study will be conducted in adult participants with symptoms of common cold assessing if 1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo. The study will also evaluate the safety of 1146A compared to placebo.

Conditions

Common Cold

A Multicenter Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold
Description

This study is designed to confirm the effectiveness of single-ingredient pseudoephedrine in children for the temporary relief of nasal congestion due to the common cold, an indication described under 21 CFR 341.80(b)(1).

Conditions

Nasal Congestion Associated With the Common Cold

Safety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold
Description

The purpose of the study will be to assess the efficacy and safety of XIGO administered orally, three times a day, compared with placebo in patients with the common cold.

Conditions

Common Cold

Efficacy Study of A Lotion to Prevent Common Colds
Description

The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses. The study will also evaluate the safety of 3804-250A.

Conditions

Common Cold, Healthy

Pomegranate Products for Prevention of Common Cold
Description

Pomegranate has a long history of use in folk medicine. There is vast data on the health benefits of pomegranate fruit and juice. Multiple studies have established the strong antioxidative effects of pomegranate polyphenols (primarily the ellagitannin punicalagin) and their health effects. A vast number of animal and human clinical studies have provided evidence on effect of pomegranate products on improving blood lipid profile, reducing blood pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic activity. We studied the protective effect of a pomegranate concentrate (POM Flu and Cold Formula®) in decreasing the incidence and duration of influenza-like illnesses and common cold among healthy adults.

Conditions

Influenza, Common Cold, Cough, Headache, Fever

Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo)
Description

The design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects; 1. The effect of receiving blinded placebo, compared to no treatment; and 2. The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.

Conditions

Common Cold

Evaluation of Echinacea for the Common Cold
Description

The purpose of this study is to determine whether three Echinacea preparations with different chemical compositions are effective for prevention or treatment of the common cold.

Conditions

Common Cold

The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
Description

The purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local IgE elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic rhinitis with local IgE elevation in this study's cohort of patients with non-allergic rhinitis identified by rhinitis history and negative skin testing for allergic rhinitis, and to determine the change, if any, in intranasal IgE levels after capsaicin treatment.

Conditions

Non-allergic Rhinitis

Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial
Description

The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis

Conditions

Vasomotor Rhinitis

Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion
Description

Nasal glucocorticosteroids (GCS) are considered first-line therapy for both allergic and non-allergic rhinitis.1-3 Nasal congestion can persist despite maximum treatment with intranasal GCS. No other drugs are superior to intranasal GCS in relieving nasal congestion. For example, antihistamines are not effective in relieving congestion.1 Oral decongestants are somewhat beneficial in relieving nasal congestion but can elevate blood pressure, cause restlessness, and cause urinary retention. Oxymetazoline, however, is a potent decongestant and the addition of it to a nasal GCS should add a considerable decongestant benefit. It may also be beneficial in patients with persistent nighttime congestion despite maximum dosages of nasal GCS. Oxymetazoline is currently recommended for three days use because of the proposed risk of rhinitis medicamentosa,4 which is increased nasal congestion caused by prolonged use of nasal decongestant sprays.5-8 The term RM was coined early in the twentieth century after several case reports described patients developing rebound congestion after using first generation intranasal decongestants such as privine hydrochloride and ephedrine for prolonged periods6,7. The histopathology and mechanism of RM has been based on animal models which may not be pertinent to humans.9-13 Studies using oxymetazoline, a newer intranasal decongestant, in individuals without rhinitis have shown conflicting evidence for the development of RM.14-16 For example, normal individuals without rhinitis using oxymetazoline three times daily for four weeks did not develop RM.17 Also, it is unknown the frequency of administration and dosage of oxymetazoline it takes to induce RM or whether RM is just a return to a patient's baseline nasal congestion as present before beginning oxymetazoline. It is also unknown whether RM is more likely or only occurs with older vasoconstrictors such as privine hydrochloride and ephedrine rather than oxymetazoline. Nasal GCS reduce the amount of rebound congestion in patients with perennial allergic rhinitis who have reportedly developed RM.18 Nasal GCS decrease nasal mucosa edema, recruitment of neutrophils and mononuclear cells, cytokine production, and late-phase nasal mediators.19-21 They may offer a protective benefit from the risk of developing RM. Oxymetazoline may also decrease inferior turbinate hypertrophy thereby permitting better adsorption of the nasal GCS. Hypothesis The addition of oxymetazoline to a nasal GCS for fourteen days will decrease the amount of congestion in subjects with allergic or non-allergic rhinitis with persistent congestion despite maximum recommended dosages of a nasal GCS. It is also hypothesized that nasal GCS protect against the development of RM secondary to oxymetazoline.

Conditions

Chronic Rhinitis

Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Description

The purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.

Conditions

Rhinitis

A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin
Description

The purpose of this Real-World Evidence study is to generate real world data from participants with cough associated with the common cold, evaluating the effects in two arms with commercially available cough syrups on health-related quality of life (QoL). Arm 1 includes one cough syrup (which can be used day or night) and Arm 2 includes the daytime cough syrup and a nighttime cough syrup.

Conditions

Common Cold, Cough

Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)
Description

A randomized-controlled interventional clinical trial to evaluate the effectiveness of EZC Pak \& EZC Pak+D for the treatment of the common cold and/or a URI.

Conditions

Common Cold

To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers
Description

This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.

Conditions

Common Cold

Nasal Swab Study to Explore the Nasal Microbia
Description

The objective of this study is to evaluate the microbial consortia and the host inflammatory factors present in the nasal passages of patients during upper respiratory symptomology and when healthy using culture and molecular analysis techniques.

Conditions

Common Cold

Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
Description

The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.

Conditions

Common Cold

Acute Cough Study In Children
Description

15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.

Conditions

Common Cold, Infections, Upper Respiratory Tract

Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
Description

The purpose of this study is compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.

Conditions

Common Cold, Pharyngitis

Mucinex Exploratory Cold Study
Description

This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.

Conditions

Common Cold

Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
Description

The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds.

Conditions

Common Cold

Trial to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection
Description

Pomegranate has a long history of use in folk medicine. There is vast data on the health benefits of pomegranate fruit and juice. Multiple studies have established the strong antioxidative effects of pomegranate polyphenols (primarily the ellagitannin punicalagin) and their health effects. A vast number of animal and human clinical studies have provided evidence on effect of pomegranate products on reducing symptoms of common cold, reducing blood pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic activity. This study will evaluate the protective effect of a pomegranate concentrate (POMx) in decreasing the incidence and duration of the common cold among healthy adults.

Conditions

Common Cold

Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers
Description

We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group.

Conditions

Common Cold, Gastroenteritis

A Trial of Echinacea in Children
Description

This is a randomized trial to determine if echinacea is effective in shortening the length and/or lessening the severity of colds in children 2 through 11 years old.

Conditions

Common Cold

Commercially Available Cannabis Products for Immune Support
Description

This study will be a prospective observation of the use of commercially available hemp and cannabis products marketed for immune support.

Conditions

Influenza, COVID-19, Common Cold

Audio Data Collection for Identification and Classification of Coughing
Description

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

Conditions

COVID-19, Coronavirus Infections, Hay Fever, Asthma, Chronic Obstructive Pulmonary Disease, Influenza, Common Cold, Respiratory Tract Infections, Healthy

Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department
Description

This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI).

Conditions

Respiratory Tract Infections, Influenza, Human, Common Cold

Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial
Description

Colds and flu cause much loss of work and school. The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: some educational material, educational material and use of alcohol hand sanitizers, and educational material and use of alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu. We will recruit 450 households in Northern Manhattan and each household will be randomly assigned to one of these three groups. We will then follow these households for 15 months to see how often they get cold and flu symptoms. We will also look at antibiotic use practices for symptoms of colds and influenza ; household member knowledge of prevention and treatment strategies for pandemic influenza and viral URIs; and rates of influenza vaccination among household members. When someone in the study has serious flu symptoms such as a high fever and cough or sore throat, we will also obtain a nasal culture (by swabbing the nose) to see if there is flu virus present.

Conditions

Respiratory Tract Infections, Common Cold

The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
Description

This study examines the cold processes of children aged 6 to less than 14. Children will be seen by the study staff 6 days in a row during the course of their naturally-acquired colds. Nasal secretions will be examined for chemicals that the body creates during a cold. Skin cells will be collected by brushing the inside of the child's cheek with a small brush. The cells will be examined for genes that may hold control the creation of these chemicals.

Conditions

Upper Respiratory Infection, Common Cold

Omalizumab Before Onset of Exacerbations
Description

OBOE is a prospective, pilot, parallel group RCT with the overall aim of examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitment for each of the yearly cohorts of OBOE will begin in February. Each cohort will be followed for a 2-6-month run-in period with the objective to gain control of each participant's asthma and to stabilize the required controller medication step level. Participants will receive routine asthma care every 1-2 months (a total of 2-4 times) during run-in using a previously described algorithm developed by the Inner-city Asthma Consortium and successfully employed in the PROSE study. The primary outcome is the change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, within 72 hours of onset of a URI as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) and 3-6 days after study drug injection.

Conditions

Asthma in Children, Atopy, Viral Upper Respiratory Infection