Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
Intervention1: RB-2410114
Fluticasone furoate
: 2 spray in each nostrils, once in morning, for 14 days
Control Intervention1: Avamys fluticasone furoate
: 2 spray in each nostrils, once in morning, f
Sponsors
PSK Pharma LLC
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed and dated Informed Consent of the patient to participate in the study. 2. Male and female patients aged 18-65 years old. 3. Diagnosis of Moderate to severe seasonal allergic rhinitis (SAR) at screening. 4. History of SAR for at least 2 years prior to screening. 5. Positive Allergy Test skin prick test and/or specific IgE) to relevant seasonal pollen within the last 12 months.
Exclusion criteria
Exclusion criteria: 1.Withdrawal of informed consent by the patient. 2.The Investigator decided that the patient should be excluded in the best interests of the patient himself. 3.The patient has experienced an undesirable phenomenon or a serious undesirable phenomenon, which, in the investigators opinion, makes it dangerous for the patient to continue participating in the study. 4.Patients failure to comply with the rules of participation in the study. 5.The patient was included in violation of the inclusion/non-inclusion criteria of the protocol. 6.Patient Suffer Perennial (year-round) rhinitis or rhinitis not related to the current pollen season. 7.Pregnancy of the study participant. 8.For administrative reasons (termination of the study by the Sponsor or regulatory authorities),as well as in case of gross violations of the protocol that may affect the results of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from the baseline in mean reflective total nasal symptom scoreTimepoint: At Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from the baseline in mean score for each rTNSS nasal symptom (rhinorrhea, nasal congestion, nasal itching, sneezing)Timepoint: At Day 7 and Day 14;Change from the baseline in mean instant total nasal symptom scoreTimepoint: At Day 7 and Day 14;4. Change from the baseline in mean score for each iTNSS nasal symptom (rhinorrhea, nasal congestion, nasal itching, sneezing)Timepoint: At Day 7 and Day 14;Change from the baseline in rTNNSS mean total ocular symptom scoreTimepoint: At Day 7 and Day 14;6. Change from the baseline in mean score for each rTNNSS ocular symptom (eye redness, eye itching/burning, tearing)Timepoint: At Day 7 and Day 14;Change from the baseline in iTNNSS mean total ocular symptom scoreTimepoint: At Day 7 and Day 14;8. Change from the baseline in mean score for each iTNNSS ocular symptom (eye redness, eye itching/burning, tearing)Timepoint: At Day 7 and Day 14;The patients adherence to treatmentTimepoint: At Day 7 and Day 14 | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Sayali Sadgune
Mudra Clincare
Outcome results
None listed