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The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test.
The Study Drugs:
Zileuton is designed to decrease swelling, tightening, and mucus in the airways.
Celecoxib is designed to decrease inflammation.
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- You will be asked about your smoking history and any drugs you may be taking.
- Blood (about 4 teaspoons) will be drawn to check your liver function. This blood draw will include a pregnancy test for women who are able to become pregnant. To take part in this study, the pregnancy test must be negative.
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other options will be discussed with you.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 2 groups:
- Group 1 will take zileuton alone.
- Group 2 will take zileuton and celecoxib.
You will have a 3 out of 4 chance of being placed in Group 1, and a 1 out of 4 chance of being placed in Group 2.
Study Drug Administration:
You will take zileuton by mouth, 2 tablets each time, twice a day for up to 7 days. Zileuton should be taken within 1 hour after your morning and evening meals. Swallow the tablets whole, without crushing or breaking them.
If you are in Group 2, you will also take 1 capsule of celecoxib by mouth, twice a day for up to 7 days. You will take celecoxib at the same time as zileuton.
If you forget to take the morning dose and you remember before the evening dose that same day, take the missed dose as soon as you remember it. However, if you do not remember until the next day, skip the missed dose and continue your regular dosing schedule. Do not take more than 2 doses of each drug in 1 day, and do not take double doses to make up for a missed dose.
You will fill out a pill diary to help you keep track of the doses. Every day, you will write down the times you take the study drug(s). If you miss a dose, you should also write that down in the pill diary.
On Day 1 (the baseline visit), the following tests and procedures will be performed:
- Your medical and surgical history will be recorded.
- You will have a physical exam.
- You will be asked about any drugs you may be taking.
- Urine will be collected to test for certain chemicals in the body that may be linked with a risk for smoking-related lung disease.
On the day before your last dose of the study drug(s), the study staff will call and remind you that you will have an end-of-study visit the next day. You will be reminded to keep taking the study drugs on schedule, including the next morning.
On the day of your end-of-study visit, you should bring the pill diary to the clinic so the research staff can review it. You should also bring the empty study drug bottle(s). The following tests and procedures will be performed:
- You will be asked about any drugs you may be taking.
- Urine will be collected to repeat the test for certain chemicals.
- Blood (about 2 teaspoons) will be drawn to check the level of zileuton in your blood.
Length of Study Participation:
You may continue taking the study drug(s) for up to 7 days. You will be taken off the study drug(s) early if intolerable side effects occur or if the study doctor thinks it is in your best interest.
You can decide to stop your study participation at any time. Tell the study staff or doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely. You may be asked if researchers can still use your medical information. You can also decide that you do not want researchers to use your information.
You should talk to your study doctor about any side effects you may have during the study.
Be sure to tell the study doctor or staff about any drugs you may be taking, including prescription drugs, over-the-counter drugs, vitamins, and herbal supplements. Other drugs may not mix well with the study drugs.
You may be asked to avoid donating blood while taking a study drug and for 1 month after you stop taking a study drug. The study staff will discuss this with you if it applies.
This is an investigational study. Giving zileuton and celecoxib to smokers is investigational. Both drugs are commercially available and FDA approved for other uses. Zileuton is FDA approved to treat asthma. Celecoxib is FDA approved to treat arthritis and a rare condition that can cause colon cancer.
Up to 80 people will take part in this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Weill Cornell Medical College (WCMC)
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:17:43-0400
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