Health Condition 1: J309- Allergic rhinitis, unspecified
Conditions
Interventions
Intervention1: Allegra-D: 1 tablet, twice daily for 1 week (7 days)
Control Intervention1: NA: NA
Sponsors
Sanofi India Limited
Cliantha Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant (male or female) must be 12 years or more 2. The participants who suffering from allergic rhinitis and are: a) Outpatients with diagnosis of AR confirmed with skin prick test on the day of screening (Evexia SPT kit) to out or indoor allergens [wheal greater than or equal to 3mm compared to control (diluent) b) Patient should have Nasal congestion score of 2 or more 3. The participant should be negative on COVID Rapid Antigen Test which is tested during the screening
Exclusion criteria
Exclusion criteria: 1. Any clinically significant abnormality identified either in medical history or during screening evaluation (e.g., physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period, which in judgment of the investigator would preclude safe completion of the study or constrains efficacy assessment. 2. History of narrow-angle glaucoma or urinary retention or seizures 3. Patients who have severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. 4. Patients having renal/hepatic insufficiency 5. Patients with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, acute rhinitis, deviation of the nasal septum, etc.), upper respiratory tract infection or acute otitis media that could interfere with judgment of the efficacy of the investigational product (IP)and patients developing cold-like symptoms 30 days before the screening visit . 6. Patients with severe asthma, bronchiectasis 7. Patients using following drugs A. within 5 days prior to the day of screening: a) Intranasal or oral: antiallergic drugs, decongestants, antihistamines, anticholinergic agents, vasoconstrictor, antihistamine-containing cold remedies, agents that can be expected to have an antiallergic/antihistaminic effect , and other agents that are indicated for allergic symptoms (sneezing, rhinorrhea, nasal congestion, etc.) b) agents that may affect the blood concentration of fexofenadine (macrolide antibiotics, azole fungicides, and preparations containing aluminum hydroxide / magnesium hydroxide) B. within 2 weeks prior to screening visit a)patients using steroids, sodium cromoglycate/nedocromil or leukotriene modifiers b)patients receiving monoamine oxidase (MAO) inhibitor therapy c)patients receiving immunotherapy or immunosuppressants or nonspecific alternative therapy (histamine containing gamma globulin preparations etc) 8. Patients who are participating in another study or who have previously participated in another study within the previous 3 months prior to the day of screening 9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized 10. Participant not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures 11. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6) 12. Any specific situation during study implementation/course that may raise ethics considerations 13. Patients were excluded from the study if they had a known or suspected history of alcoholism or drug abuse; 14. Patients were excluded from the study if they had hypersensitivity to, fexofenadine HCl, or pseudoephedrine HCl; 15. Participants who withdraw consent during the screening (starting from signed ICF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety of Allegra D (Fexofenadine HCL 60 + pseudoephedrine HCL 120 fixed dose combination)Timepoint: 2 week (Approx 16 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of Allegra D (Fexofenadine 60 + pseudoephedrine 120 combination) measured as per change in Total symptom score (TSS) and Nasal congestion score (NCS) as assessed by doctorTimepoint: 2 week (Approx 16 days) | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Ltd
Outcome results
None listed