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
- Conditions
- Health Condition 1: null- 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
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
2. 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
1. 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.
3. 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.
15. 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, 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.
20. Patients with positive serology laboratory values.
21. 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
- Secondary Outcome Measures
Name Time Method