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Completed

NCT Number: NCT02819856

SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK), Physical Exam, Adverse Events (AEs) and Labs baseline to post-treatment.

The secondary objectives of this study are to determine Pharmacogenomics and Pharmacodynamics of SPI-1005.

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Key information

Conditions

Ototoxicity Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Ear Diseases Genetic Diseases, Inborn Hearing Disorders Hearing Loss Infant, Newborn, Diseases Labyrinth Diseases Lung Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Respiratory Tract Diseases Sensation Disorders Signs and Symptoms Tinnitus Vertigo Vestibular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

Randomized, double-blind, placebo-controlled study to evaluate the safety, and efficacy of SPI-1005 in Cystic Fibrosis patients with Acute Pulmonary Exacerbation receiving intravenous tobramycin at risk for ototoxicity. All patients will undergo baseline testing and have their severity of lung function, sensorineural hearing loss, tinnitus and vertigo determined before the start of SPI-1005 treatment. SPI-1005 treatment will start within first two days of IV tobramycin treatment and be administered concomitantly. At the end of the 21-day course of SPI-1005 and 28 days following the cessation of SPI-1005, patients will have their hearing loss, tinnitus and vertigo reassessed. Assessments may also include additional audiometric and pulmonary testing, and additional follow-up testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary exacerbation.
  • Voluntarily consent to participate in the study.
  • Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
  • Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or IUD in place for at least 3 months prior to study through study completion; or Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or Stable hormonal contraceptive for at least 3 months prior to study through study completion.
  • Ability to perform all behavioral tests as indicated.

Exclusion criteria

  • Current use or within 60 days prior to study enrollment the following IV ototoxic medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide).
  • History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma.
  • History of middle ear or inner ear surgery.
  • Current conductive hearing loss or middle ear effusion.
  • Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or psychiatric disease.
  • History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
  • Participation in another investigational drug or device study within 30 days prior to study enrollment.
  • Female patients who are pregnant or breastfeeding.

Treatment and study plan

Placebo

Drug

0 mg SPI-1005 bid po x 21d

Other names: SPI-1000

SPI-1005 Ebselen 200mg Capsule x1

Drug

200 mg SPI-1005 bid po x21d

Other names: SPI-1005 Low Dose

SPI-1005 Ebselen 200mg Capsule x2

Drug

400 mg SPI-1005 bid po x 21d

Other names: SPI-1005 Mid Dose

SPI-1005 Ebselen 200mg Capsule x3

Drug

600 mg SPI-1005 bid po x 21d

Other names: SPI-1005 High Dose

Primary outcomes

  1. Sensorineural Hearing Loss Using Pure-tone Audiometry

    Time frame: 4 weeks post-tobramycin

    Number of participants with ototoxicity: Sensorineural hearing loss using pure-tone audiometry according to the American Speech-Language-Hearing Association (ASHA) criteria for ototoxicity.

  2. Distortion Product Otoacoustic Emissions

    Time frame: 4 weeks post-tobramycin

    Number of participants with ototoxicity: Decreases in Distortion Product Otoacoustic Emissions (DPOAE), defined as a greater than or equal to 5 dB decrease in DPOAE amplitude in at least one test frequency.

  3. Speech Discrimination

    Time frame: 4 weeks post-tobramycin

    Number of participants with ototoxicity: Decreases in speech discrimination using the Words in Noise test (WIN) score (0-35, where higher scores are a better outcome), defined as a 10% or greater decrease in WIN score from participant's baseline score.

  4. Tinnitus Severity

    Time frame: 4 weeks post-tobramycin

    Number of participants with ototoxicity: Increases in Tinnitus Functional Index (TFI) score (0-100, where higher scores are a worse outcome), defined as an increase of 10 points or more from baseline.

  5. Vertigo Severity

    Time frame: 4 weeks post-tobramycin

    Number of participants with vestibulotoxicity: Increases in Vertigo Symptom Scale - Short Form score (0-60, where higher scores are a worse outcome), defined as an increase of 6 points or more from baseline.

  6. Changes in Lung Function

    Time frame: 4 weeks post-tobramycin

    Evaluation of lung function using spirometry, assessed using the change from baseline in Forced Expiratory Volume in 1 second (FEV1).

Sponsors and collaborators

Lead sponsor

Sound Pharmaceuticals, Incorporated

Industry

Collaborators

  • Cystic Fibrosis Foundation
  • Medical University of South Carolina

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for Ototoxicity

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jun 30, 2016
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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