Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults (NCT03265288) | Clinical Trial Compass
CompletedPhase 2
Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults
United States166 participantsStarted 2018-11-05
Plain-language summary
An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Screening FEV1 between 40% and 100% predicted value for age, gender and height, in patients capable of properly performing the test;
* History of pulmonary exacerbation, defined as at least one (1) pulmonary exacerbation in the year prior to Screening which resulted in documented intravenous or Oral antibiotics;
* Patients are eligible independently of their history of pulmonary Pseudomonas aeruginosa (PsA) infection and their PsA status at screening;
* If taking Kalydeco® (ivacaftor), Orkambi® (ivacaftor/lumacaftor), Symdeko® (ivacaftor/tezacaftor) or other commercially available CFTR modulator products, patients must be taking it for a minimum of 3 months prior to screening if naïve to CFTR modulators and 1 month if switched from another CFTR modulator product and deemed to tolerate it;
* No change in CF and allowed systemic chronic therapy for a minimum of 5 weeks prior to randomization, of which 2 weeks minimum are prior to screening;
* Female patients of child bearing potential should be on highly effective contraceptive methods during the study;
* Male patients with spouse or partner of child bearing potential, or pregnant, are eligible if they use an appropriate method of contraception.
Exclusion Criteria:
* Pregnancy: due to the potential teratogenic effects of retinoids, pregnant women are NOT eligible;
* Breast milk feeding by study patient is NOT allowed;
* Clinically abnormal renal function: serum creatinine \> 132 μM (1.5 mg/dL);
* Clinic…
What they're measuring
1
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1%)
Timeframe: From baseline to 24 weeks
2
Summary of Treatment Emergent Adverse Events With ≥ 10% Incidence