Welcome to the FLASH Study clinical trial website!
A clinical research opportunity for people with uncontrolled Asthma
Asthma is a chronic disease with no cure. For some people, current treatments may no longer result in control of their symptoms. As such, alternative treatment options are needed. The FLASH Study is looking for participants who have moderate-to-severe asthma that is uncontrolled with their current treatment alone to evaluate the safety and effectiveness of an investigational drug.
Individual may qualify for the study if they:
- Are 18 to 80 years of age
- Have been diagnosed with asthma for at least 1 year
- Meet additional study criteria.
Reimbursement for reasonable, out-of-pocket expenses for travel and accommodations will be available to qualified individuals.
About the FLASH Study
What is the FLASH study?
The FLASH study is a clinical research study for people with moderate-to-severe asthma that cannot control their asthma with their current treatment alone.
The investigational drug, AZD5718, is a tablet that can be taken once a day at home and is being developed as a potential treatment for heart disease, kidney disease, as well as asthma. Investigational drugs are not approved to be prescribed for treatment at this time as they are still being evaluated in clinical studies such as the FLASH study.
The FLASH Study is approximately 19 weeks long.
Study Participation includes:
- Screening period (up to 2 weeks) – check whether you can participate in the study
- Run-In period (4 weeks) – prior to randomization, participants will be educated on the study expectations including use of hand-help spirometer (a device used to measure the amount of are you breathe in and breathe out) and electronic diary (e-diary)
- Treatment period (12 weeks) – eligible participants will be randomly assigned (like pulling a number out of a hat) to receive the investigational drug, comparator (an asthma drug already on the market), or placebo. A Placebo looks like the investigational drug but contains no active ingredients
- Follow-Up (1 week) – at the end of the treatment period, you will have some final study assessments, including to check for any adverse reactions you may have experienced
About Asthma
Asthma is a long-term chronic lung disease that affects an estimated 339 million people worldwide. Asthma impacts a person’s airways and causes problems with their breathing. There is no cure for asthma, but symptoms can be managed with treatments. Symptoms and signs of asthma include, shortness of breath, chest tightness or pain, wheezing, and coughing.
These symptoms can be brought on by different triggers physical activity, allergies, respiratory infections (such as the common cold), cold air, air pollutants, medications, stress, and more. It is unknown why some individuals will develop asthma, but a few factors increase the likelihood of developing asthma:
- Genetics (having parents or siblings with asthma)
- Allergies
- Being overweight
- Being a smoker or exposure to secondhand smoke
- Exposure to pollutants
Information on Clinical Research Studies
What Is a Clinical Study?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies (studies that collect data only such as surveys). ClinicalTrials.gov includes both interventional and observational studies.
Clinical Trials
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.
Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).
Some people who are not eligible to participate in a clinical trial may be able to get experimental drugs or devices outside of a clinical trial through expanded access. See more information on expanded access from the FDA.
* National Library of Medicine (NLM) and ClinicalTrials.gov. (2019, March) Learn About Clinical Studies. Retrieved October 3, 2019, from http://www.clinicaltrials.gov/.