Summary:
A Clinical Research Study for Adults with Persistent Asthma
Why is the asthma research study being done?
The research study is being done to test the safety, tolerability, and effectiveness of a new investigational study drug. The study will explore whether the investigational study drug improves asthma symptoms and control in adults with persistent asthma.
What are the study drugs?
The investigational study drug is being evaluated to see if it will improve the symptoms and control of asthma.
Montelukast is a medication that is approved worldwide for the treatment of asthma.
Study participants may receive placebo during the study. A placebo looks like the study drug but contains no active ingredients.
The investigational study medication, montelukast, and placebo are given as tablets that will be taken by mouth with water.
Albuterol is an inhaled short-acting beta2-agonist that acts quickly to relax tight muscles around the airways, allowing air to flow through them. All study participants will be provided with this medication to use, if needed, during the study.
What will I be asked to do?
The study will last up to 17 weeks plus a follow-up visit.
If you take part in the study, you will need to:
- Attend clinic visits and have procedures to check on your health, including physical exams, lab tests, electrocardiograms (ECG/EKGs), and lung function (breathing) tests
- Take the study drugs as directed
- Test your breathing using a peak flow meter twice a day
- Record any medications you are using, your sleep schedule, results of breathing tests, and any signs and symptoms of asthma in an electronic diary device (e-diary) twice a day
Each study participant will be provided with an e-diary and a peak flow meter to take and use at home while participating in the study. The study staff will train you on how to complete the e-diary and how to use the peak flow meter.
There are other requirements and responsibilities that the study doctor or staff will review with you.
What are the potential risks and benefits?
Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.
The information learned from the study and your participation may help improve future treatment options for people with asthma.
All study participants will receive the study-related drugs and tests, and procedures, at no charge. Study participants may also be compensated for travel to and from clinic visits.
Who can participate?
You may be eligible to participate in this study if you:
- Are 18 to 65 years old
- Have had symptoms of persistent asthma for at least 1 year
- Have never smoked or have been a non-smoker for 1 year or longer
There are other eligibility criteria that the study doctor or staff will review with you.
Study participation is voluntary. You do not have to participate in the asthma research study to receive treatment for your asthma. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have. Your health is very important to them.
Where are the studies taking place?
Click here for a list of study locations.
For more information or to find out if you qualify, visit The Asthma Questionnaire.