A Study of an Experimental Nasal Spray in Subjects With Early Signs of

Status Completed

Clinical Trial Summary

This study will test 200 people to see if an experimental nasal spray has an effect on symptoms of the common cold if used when the symptoms start. At the first visit to the clinic, potential subjects will have tests to make sure they qualify to participate in the study.

If they qualify, they will have an equal chance of receiving the experimental nasal spray or a sham nasal spray (one that does not have the experimental formula). At the first visit, subjects will receive their assigned nasal spray and use it once at the clinic. They will also receive a booklet called a diary. Subjects will take the rest of their treatments for day 1 at home, and for the next six days, they will use the nasal spray four times per day and record their symptoms in the diary, as instructed. Then subjects will come back to the clinic for a final visit.

Clinical Trial Description

This is an investigation in healthy subjects with early signs of common cold. Subjects will be randomly assigned in a 1:1 ratio to receive either Polymeric Nasal Spray or a matching placebo nasal spray.

Subjects will be screened for eligibility and randomized to treatment at the Screening/ Randomization Visit (Day 1). Subjects will apply the first dose of the nasal spray at this visit under supervision. The other applications will take place at home on Day 1. On Days 2 through 7, subjects will use their assigned nasal spray as 2 sprays per nostril, 4 times per day.

One Follow up Visit will be conducted within 3 days of the last application of nasal spray.

Enrollment will continue until 200 subjects have completed the investigation (100 per treatment group). The subject and the investigative staff will be blinded to the assigned nasal spray.

Efficacy will be measured, and recorded in the subject's diary, and safety will be assessed by reported AEs and ADEs. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Common Cold

Clinical Trial Details

NCT number	NCT01488604
Study type	Interventional
Source	Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status	Completed
Phase	N/A
Start date	January 2012
Completion date	May 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05269290` - Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections	Phase 3
Completed	`NCT02451163` - DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly	Phase 2
Completed	`NCT01944631` - Iota-Carrageenan Nasal Spray in Common Cold	Phase 4
Completed	`NCT01651715` - Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections	Phase 1/Phase 2
Completed	`NCT00963443` - Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold	Phase 3
Completed	`NCT00778648` - Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms	N/A
Completed	`NCT00065715` - Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo)	Phase 3
Completed	`NCT00032500` - Evaluation of Echinacea for the Common Cold	Phase 2
Not yet recruiting	`NCT05070650` - Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold	Phase 3
Not yet recruiting	`NCT04073511` - Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold	N/A
Completed	`NCT04144491` - Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda	N/A
Completed	`NCT03189537` - Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections	Phase 3
Terminated	`NCT01964885` - Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections	Phase 3
Completed	`NCT01277081` - Effect of Paracetamol on the Common Cold	Phase 2
Completed	`NCT01728090` - Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections	Phase 4
Completed	`NCT00405509` - The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years	N/A
Completed	`NCT01033526` - Symptomatic Treatment of Common Cold Symptoms	Phase 4
Completed	`NCT05556148` - Otrivine: Quality of Life (QoL) Impact in a Real-World Setting	Phase 4
Terminated	`NCT03339726` - Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold	Phase 2
Completed	`NCT01361399` - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study of an Experimental Nasal Spray in Subjects With Early Signs of the Common Cold

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms