Subject: Participation in surveillance “Assessment of drug utilization pattern of antihistamines in Indian patients with chronic spontaneous urticaria (CSU)”
Urticaria is one of the most prevalent dermatology diseases in India and has a profound effect on quality of life and causes immense distress to the patients, necessitating effective treatment. More than 50 years after the first introduction of an antihistamine into allergy therapy, antihistamines still represent modern and exciting agents contributing to the continuous improvement of antiallergic therapy. Non-sedating second generation antihistamines are the first line treatment options in management of urticaria. Various clinical studies and research have been done in last few years on the treatment regimens, usage of anti-histamines in urticaria, in which Updosing is one of the latest & revolutionary advancement observed across the globe.
Guidelines recommend (EAACI/GA²LEN/EuroGuiDerm/APAAACI and Skin Allergy Research Society's Guideline-2022) second generation H1 antihistamines as the first line treatment and the dose can be increased to meet the expected results.
This retrospective, cross-sectional multicenter surveillance is planned to evaluate the drug utilization pattern of antihistamines in patients with CSU in India.
We invite you to participate in this surveillance. On acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided, from the patient’s medical records (case papers and investigational reports – hereafter referred as source documents).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol.
We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the DCF.
In alignment with good clinical research practices, an independent CRO may monitor this surveillance and do the source data verification of the data captured in the DCF with copies of the patients’ source medical records (case papers and investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients’ medical records.
If you agree to participate in the said surveillance, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records.
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