Nasal Congestion Clinical Trial
Official title:
An Interventional, Non-comparative, Single-center Post Marketing Clinical Follow-up (PMCF) Study to Evaluate Performance and Safety of "NASAL SPRAYS " Used to Relieve Nasal Congestion and Dryness
Acute viral upper respiratory tract infection, also known as common cold, is the most frequently observed infectious disease in human beings. Although common cold is a self-limiting disease, symptoms such as runny nose, nasal congestion, sneezing, cough, sore throat, are troublesome. Dry nose is characterized by nasal mucosa dryness, itching, mild burning, crusting, and dehydrated mucus. Causes of dry nose sensation include climatic factors, dry room air, workplace conditions, allergic rhinitis, endonasal sinus surgery. Dry nose symptoms occur concurrently and may be the first signs of a common cold infection and rhinitis sicca (also known atrophic rhinitis). Saline nasal sprays are broadly used as first-line treatment to relieve nasal congestion or nasal dryness. Isotonic saline solutions preferentially aim at cleansing and moistening of the nasal mucosa and thus are suitable for treatment of dry nose symptoms. Hypertonic saline solutions are generally used for decongestion of the nasal mucosa. For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "NASAL SPRAYS" used to relieve nasal congestion and dryness. The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with the use of "NASAL SPRAYS" according to the instruction for use (IFU). Each pediatric subject whose parent(s)/legal guardian signed an Informed Consent Form (ICF), and each adult subject after signing the ICF, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed. At baseline visit (V0), one of the "NASAL SPRAYS" will be administered to the enrolled subject. The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake. The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according to the IFU, depend on various factors regarding the physiology of the patients (e.g. nasal congestion/ obstruction, sneezing), the age of the patient, and for pediatric subjects, their birth characteristics (e.g. age, prematurity, birthweight).
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00665977 -
Effect of Heated Humidity With Thermosmartâ„¢ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
|
Phase 3 | |
Completed |
NCT00957996 -
Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza
|
Phase 3 | |
Completed |
NCT00829634 -
Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
|
N/A | |
Completed |
NCT00662337 -
Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride
|
Phase 1 | |
Completed |
NCT05247333 -
Implementation of a Minor Ailment Service in Community Pharmacy Practice
|
N/A | |
Recruiting |
NCT05244148 -
Two Seawater-based Formulations for Relief of Nasal Congestion in Paediatric Subjects
|
N/A | |
Completed |
NCT05159271 -
Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults
|
N/A | |
Completed |
NCT02113449 -
Market Potential of Carbon Dioxide Nasal Spray
|
Phase 2 | |
Terminated |
NCT00958776 -
A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza
|
Phase 3 | |
Completed |
NCT00648973 -
To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
|
Phase 4 | |
Completed |
NCT03399721 -
Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
|
N/A | |
Completed |
NCT01354418 -
Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)
|
Phase 1 | |
Completed |
NCT04797936 -
BNO 1030 Extract (Imupret) in the Treatment of Mild Forms of COVID-19
|
Phase 4 | |
Completed |
NCT03906968 -
The Safety and Efficacy of a SinuSonic Intervention
|
N/A | |
Completed |
NCT02100605 -
Study on Hypertonic Saline Nasal Spray
|
N/A | |
Recruiting |
NCT06323304 -
Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis
|
N/A | |
Withdrawn |
NCT04790487 -
Chlorpheniramine Maleate Nasal Spray for Chronic Rhinitis
|
Phase 2/Phase 3 | |
Completed |
NCT01448057 -
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
|
Phase 3 | |
Completed |
NCT01129765 -
Home Usability of a Nasal Lavage System in Children
|
N/A | |
Completed |
NCT04910139 -
A User Study of the Soniflow System for Nasal Congestion Relief
|
N/A |