Why is the Asthma Study being done?
This 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?
Participants in the asthma study may receive the following drugs:
- The investigational study drug is being evaluated to see if it will improve symptoms and control of asthma
- Montelukast is a medication that is approved worldwide for the treatment of asthma
- Placebo looks like the investigational study drug but contains no active ingredients
The investigational study drug, 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 qualified 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.