A Study of Experimental INS1007 For Non-Cystic Fibrosis Bronchiectasis (damage to airways, making it difficult to clear mucus)

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Age: 18 to 85 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Non-Cystic Fibrosis Bronchiectasis, Bronchiectasis
Type: Drug study, Phase 2
Target:
2 Participants
Investigator:
Description
This is a clinical research study of an experimental drug called INS1007. “Experimental” means that the study drug is currently being tested in clinical research studies. We might not have all the information about it. INS1007 is not approved to treat non Cystic Fibrosis (CF) bronchiectasis by the Food and Drug Administration (FDA). It is undergoing clinical investigations to determine if INS1007 is safe and effective.

INS1007 is taken as tablets and has been studied in animals and humans. Patients like you, with non CF bronchiectasis, may have problems with managing sputum movemen. You may also have worsening respiratory symptoms. INS1007 may help manage these issues.

The purpose of this clinical research study is to evaluate the safety and effectiveness of INS1007 as a treatment for non-CF bronchiectasis. We also want to measure the concentration of INS1007 in the blood after treatment.
This study requires

The treatment you get will be chosen by chance, like flipping a coin. You will have an equal chance of being given each treatment. You will be randomly assigned to either the INS1007 10-mg, or 25-mg treatment groups, or the placebo treatment group. A placebo is a medication with no active ingredients. It looks the same as the active ingredient tablet but it is not. Neither you nor the study doctor will know which treatment you are getting.

The study will be explained to you before any study-related tests and procedures are done.

The following is an overview of the study visits required. The study team will discuss the specific study-related procedures for each visit with you.

Screening Period (Visit 1) Visit 2 (Baseline, Day 1) Randomization Visit 3 (Week 2, Day 15) Visit 4 (Week 4, Day 29) Visit 5 (Week 8, Day 57) Visit 6 (Week 12, Day 85) Visit 7 (Week 16, Day 113) Visit 8 (Week 20, Day 141) Visit 9 (Week 24, Day 169, End of Treatment) Visit 10 (Week 28, Day 197, End of Study)

Who can participate

Inclusion criteria:

  1. Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections)
  2. Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
  3. Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening

Exclusion criteria:

  1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
  2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
  3. Are current smokers
  4. Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
  5. Have any acute infections, (including respiratory infections)
Benefits and risks of participating
BENEFITS:

We cannot promise any benefit to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you for your time and effort per the chart below:

Screening (Visit 1): $120
Visit 2: $120
Visit 3: $90
Visit 4: $90
Visit 5: $120
Visit 6 : $90
Visit 7 : $90
Visit 8 : $90
Visit 9 : $120
Visit 10 : $60

In addition to these payments, you will be reimbursed for mileage driven to UC Davis Health at the standard IRS rate for any visits that exceed 20 miles. If you have an unscheduled visit, you will be paid $30 per hour on site.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for approximately 32 weeks.
Recruitment period
From April 19, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Non-Cystic Fibrosis Bronchiectasis