A Prospective, Randomized Double Blind, Active Controlled, parallel Comparative Clinical Study to Evaluate the Efficacy and Safety of DEXAMETHASONE-AGIO (Dexamethasone sodium phosphate 4mg/ml) Injection of Agio Pharmaceuticals Ltd. Mumbai, India with DEXAMETHASONE (Dexamethasone sodium phosphate 4mg/ml) Injection of the company KRKA Slovenia in the treatment of severe or incapacitating allergic conditions of skin and respiratory tract

Agio Pharmaceuticals Ltd1 site in 1 country60 target enrollmentStarted: October 25, 2017Last updated: February 18, 2021

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor
Enrollment: 60
Locations: 1
Primary Endpoint: Patients with skin allergies

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

A prospective randomised Double blind active controlled parallel comparative clinical study to Evaluate the efficacy and safety of Dexamethasone Agio injection of AGIO Pharmaceuticals Ltd. Mumbai with Dexamethason Injection of KRKA Slovenia in the treatment of severe or incapcitating allergic conditions of skin and respiratory tract Duration Of the study for 17 days Total Number of Subjects 60

Study Design

Study Type: Interventional
Allocation: Computer generated randomization
Masking: Participant and Investigator Blinded

Eligibility Criteria

Ages: 18.00 Year(s) to 60.00 Year(s) (—)
Sex: All

Inclusion Criteria

•Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
•Patients with severe or incapacitating allergic conditions: Bronchial asthma Acute allergic bronchitis Contact dermatitis Atopic dermatitis Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Urticarial transfusion reactions Acute noninfectious laryngeal edema.

Exclusion Criteria

•Patients who are not willing to give written informed consent
•A medical history of significant hypersensitivity or allergic reaction to dexamethasone or any corticosteroids.
•Current chronic use of steroids
•patients with smoking habit
•Patients being treated with antibiotics
•Participation in any clinical trials prior to 12 months
•Current treatment with immune-suppressants (eg, cyclosporine or methotrexate)
•Current treatment with phototherapy (UVA, UVB, PUVA and lasers)
•Use of systemic corticosteroids in the visit to include Topical treatments at the site of lesions in the 15 days preceding the survey
•Presence of secondary infections at the site of treatment, diagnosed clinically; 11.Presence of other eczematous diseases, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckleys syndrome
•Pregnant or lactating women
•Chronic alcoholism
•Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patients participation in the study.
•History of diabetic mellitus, thyroid dysfunction
•Current or suspected diagnosis of viral, fungal, non infectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis,
•History of muscle weakness
•Severely immunocompromised patients
•Bacteremia and systemic fungal infections, glaucoma, hypersensitivity to any of the products components, Cushingâ€™s syndrome, gastric and duodenal ulcers, certain viral infections, i.e. varicella, herpes genita previous or current exposure to chicken pox, varicella virus and measles or have taken vaccination for the same.
•Patients with positive serology laboratory values.
•History of intubations for asthma or co morbidities (Chronic Lung Disease (CLD), Congenital Heart Defects (CHD), or neurologic disorders).