Evaluation of effectiveness of different inhalers in patients of chronic obstructive pulmonary disease

Chronic Obstructive Pulmonary Disease is characterised by persistent airflow limitation and respiratory symptoms that are due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. COPD is the fourth leading cause of death and it affects more than 10 million persons in the United States. The prevalance of COPD in India is reported to be 7.4%. Inhaled therapy is the mainstay of COPD treatment, and direct delivery of medication to the lung allows for optimal efficacy and safety. Deposition of inhaled drugs is sensitive to the brething pattern of patients which also depends on disease severity. These characteristics impact the patient’s ability to properly use specific inhaler devices and therefore affect adherence to therapy, therapeutic outcomes and quality of life. Worsening symptoms or increased frequency of exacerbations may not always indicate disease progression but may indicate the improper use of an inhaler device. Improper handling of the inhaler device may cause decreased pulmonary aerosol drug deposition and low therapeutic effects. The more efficient, user friendly delivery devices may increase clinical effectiveness and patient compliance. Therefore, formulation improvements and new device technologies have been developed through an improved understanding of the mechanisms of aerosolization and lung deposition. New emerging device technologies on minimising patient errors, expanding the range of inhaled drugs, improving delivery efficiency, increasing dose consistency and dosage levels, thus, simplifying device operation. pMDI, DPI, BA-MDI will be used for the comparison. In comparison with a pMDI, BAIs have demonstrated consistent lung deposition not only in patients with good hand-mouth coordination but also in patients with poor hand-mouth coordination while using a pMDI. However the studies conducted on novel BAI are limited particularly in our country India. The present study is designed to evaluate the clinical effectiveness of different inhaler devices in the delivery of inhaled corticosteroids and beta 2 agonists for patients with COPD. It will include the effectiveness of device handling, ease of use, errors, and participant perception regarding BA-MDI, pMDI and DPI in patients with COPD. The present study is prospective, open labelled and observational. It will be conducted on patients of chronic obstructive lung disease attending the IPD or OPD of Tuberculosis and Chest Diseases, J.N.Medical College & Hospital, A.M.U., Aligarh. The final diagnosis of COPD will be made based on the Global Initiative fro Lung Disease (GOLD) 2022 severity classification.  The patients of COPD of age more than 18 years will be included. Written Informed consent will be taken from all enrolled patients. Only those patients who are fulfilling the inclusion and exclusion criteria will be grouped and analysed at the end of study. Follow up of the patients will be done at two weeks interval till three months. The patients will be assessed on the paarmeters : PFT, SGRQs, Device handling and Ease of use questionnaire responses, etc.