Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients

Stopped early · Phase 2

Conditions studied: Cystic Fibrosis

In brief

Prospective, randomized, placebo controlled, phase II clinical study of subjects crossing over from an approved inhaled antibiotic to inhaled nitric oxide as compared to a placebo control arm.

Key facts

Study ID

NCT02498535

Run by

Novoteris, LLC

People needed

49

Starts

2017-02-22

Expected to finish

2020-06-01

Last updated by the study team

2021-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of Cystic Fibrosis based on the following criteria:
• positive sweat chloride 60 mEq/liter (by pilocarpine iontophoresis); and/or
• a genotype with two identifiable mutations consistent with CF
• Presence of Pseudomonas aeruginosa, Staphylococcus aureus or Stenotrophomonas maltophilia in the screening sputum culture.
• Chronic microbial lung colonization (≥6 months) with presence of Pseudomonas aeruginosa, Staphylococcus aureus or Stenotrophomonas maltophilia in at least two (2) sputum cultures in the past year (the screening culture can count as one of the two positive cultures).
• Ongoing chronic inhaled antibiotic therapy for at least 3 months prior to (screening or baseline).
• For subjects on cycled therapy, at least 2 cycles of drug need to have been completed prior to baseline.
• Willing to be off of inhaled antibiotic therapy from Day 1 to Day 15
• Male or female subjects ≥18 years
• FEV1 <85% and >35% at screening and baseline
• SaO2 >90% on room air at screening and baseline
• Clinically stable with no significant changes in health status within 14 days prior to Baseline
• Written Informed Consent and HIPAA authorization
• Non-smoker for at least 6 months prior to screening and agrees not to smoke during the study
• Chest x-ray within the last six (6) months. If none, a chest x-ray is required before randomization.
• Willing and able to comply with the treatment schedule and procedures.

You may not qualify if…

• Initiation of any new chronic therapy (e.g., ibuprofen, Pulmozyme®, hypertonic saline, azithromycin, TOBI®, Cayston®) within 4 weeks prior to screening.
• Use of antibiotics [oral, intravenous (iv), and/or inhaled] for acute respiratory symptoms within 2 weeks prior to baseline.
• Significant hemoptysis within 30 days prior to screening (≥5 mL of blood in one coughing episode or >30 mL of blood in a 24 hour period)
• History of colonization with nontuberculosis mycobacterium in sputum culture. The investigator can be guided by the following suggested criteria for a subject to be considered free of colonization:
• Two respiratory tract cultures negative for NTM in the last year, with no subsequent positive cultures; and
• these 2 respiratory cultures must be separated by at least 3 months; and
• one of these two cultures has to have been obtained within the last 6 months
• Cardiac (left heart) insufficiency (defined as LVEF <35%) at screening
• Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening
• Any of the following abnormal lab values at Screening:
• Hemoglobin < 10 g/dl
• Methemoglobn >3%
• Platelet count <100,000/mm3
• Prothrombin time international ratio (INR) > 1.5
• Abnormal liver function defined as any two of the following:
• ALT >3 x ULN
• AST >3 x ULN
• ALP > 3 x ULN
• GGT > 3 x ULN
• Abnormal liver function defined as:
• ALT >5 x ULN
• AST >5 x ULN
• Abnormal renal function defined as:
• Calculated Creatinine Clearance < 50 mL (as calculated by Cockcroft/Gault)
• For women of child bearing potential:

Where it is running

• * Entire USA* The sponsor will provide air transportation and housing to patients that are not located in the area of clinical trial sites. All trial sites can treat adults. — Garden Grove, California, United States
• Children's Hospital of Los Angeles (Adults can be treated here) (Site No. 500) — Los Angeles, California, United States
• Nationwide Children's Hospital (Adults can be treated here) (Site No. 600) — Columbus, Ohio, United States
• Medical University of South Carolina (Site No. 200) — Charleston, South Carolina, United States
• University of Washington Medical Center (Site No. 100) — Seattle, Washington, United States
• Medical College of Wisconsin (Site No. 400) — Milwaukee, Wisconsin, United States
• University of British Columbia, St. Paul's Hospital (Site No. 300) — Vancouver, B.C., Canada

Full record on ClinicalTrials.gov

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