A Comparative Clinical Study to Evaluate the effectiveness of DEXAMETHASONE-AGIO Injection in the treatment of severe or incapacitating allergic conditions of skin and respiratory tract

Phase 3

Completed

• Conditions: Treatment of severe or incapacitating allergic conditions of skin and respiratory tract

• Registration Number: CTRI/2017/10/010105
• Lead Sponsor: Agio Pharmaceuticals Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-25
• Study Completion: 2019-09-18
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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 2.
• A medical history of significant hypersensitivity or allergic reaction to dexamethasone or any corticosteroids.
• Current chronic use of steroids 4.
• patients with smoking habit 5.
• Patients being treated with antibiotics 6.
• Participation in any clinical trials prior to 12 months 7.
• Current treatment with immune-suppressants (eg, cyclosporine or methotrexate) 8.
• Current treatment with phototherapy (UVA, UVB, PUVA and lasers) 9.
• Use of systemic corticosteroids in the visit to include Topical treatments at the site of lesions in the 15 days preceding the survey 10.
• 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 12.
• Pregnant or lactating women 13.
• Chronic alcoholism 14.
• 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 16.
• Current or suspected diagnosis of viral, fungal, non infectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis, 17.
• History of muscle weakness 18.
• Severely immunocompromised patients 19.
• Bacteremia and systemic fungal infections, glaucoma, hypersensitivity to any of the products components, Cushing’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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients with skin allergies	Baseline to End of Treatment
1. Percentage change in the total score of signs and symptoms	Baseline to End of Treatment
Constitute secondary signals of efficacy including excoriation,oozing,crusting and lichenification.	Baseline to End of Treatment
Patients with respiratory allergies	Baseline to End of Treatment
1. The time from study entry to respiratory distress with 5 days of treatment	Baseline to End of Treatment
2.wheezing and Retraction of muscles along with Respiratory rate and oxygen saturation score of 0 to 3	Baseline to End of Treatment
3. The duration of oxygen therapy	Baseline to End of Treatment

Secondary Outcome Measures

Name	Time	Method
Arm 1 (Patients with skin allergies):Adverse events	Arm 2 (Patients with respiratory allergies):Adverse events

Trial Locations

Locations (1)

Rajarajeswari Medical College & Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Rajarajeswari Medical College & Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr KN Mohan Rao

Principal investigator

9845270973

kotnur.rao@gmail.com