Extrait

Background and study aims We are carrying out a study of 40 volunteers to see if face masks reduce the amount of air pollutants in urine. These chemicals measure how much air pollution a person has breathed over the past one or two days. According to the United Nations, Hanoi is one of the top six cities with the highest amount of pollution in the world. Air pollution is believed to cause different kinds of diseases in people, especially in developing countries. The long-term goal of this study is to see if the R95 face mask can reduce the amount of respiratory diseases (diseases that make it hard to breathe) caused by air pollution. The immediate goal of the study is to investigate whether the face mask reduces the amount of air pollution breathed by 40 healthy volunteers. Who can participate? This study aims to recruit 40 healthy adult volunteers (20 males and 20 females) who work outside on the street for at least 4 hours every 24 hours. Examples of people that work on the street include motorbike drivers, street vendors, gas station workers and construction workers. What does the study involve? The study will last two weeks. All volunteers will begin the study at the same time. There will be two different schedules describing when and for how long volunteers should wear their masks. Volunteers will be randomly assigned to one of these two schedules. Certain chemicals in urine measure how much air pollution a person has inhaled during the past one or two days. Urine samples will be collected on Tuesday and Friday afternoons, and these chemicals will be measured to determine how much air pollution the volunteer has breathed. Two study employees will visit volunteers at their workplace to check whether or not volunteers are actually wearing their face masks. Study employees will visit volunteers without telling them in advance and at random times. Study employees will remind volunteers to wear their masks by sending them text messages each day. What are the possible benefits and risks of participating? The study will pay participants 3 USD in Vietnamese dollars for each urine specimen and 1 USD for each day participants write in their diary. If participants follow all instructions correctly for the 15 days of the study, they will receive 30 USD in Vietnamese dollars. Where is the study run from? The study is run by researchers at the Oxford University Clinical Research Unit (OUCRU) – Viet Nam, in association with the London School of Hygiene and Tropical Medicine (LSHTM) and the Hospital for Tropical Diseases in Ho Chi Minh City. When is study starting and how long is it expected to run for? The study ran from July to October 2009 for a total of 3 months. The study has been completed. Who is funding the study? The Wellcome Trust (UK). Who is the main contact? The Clinical Trials Unit at the Oxford University Clinical Research Unit – Viet Nam. +84839241983

Critère d'inclusion

• Air pollution & respiratory problems

Liens

• ictrp
• isrctn