Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

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Brief Title

Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

Official Title

A Placebo Controlled, Randomized, Parallel Cohort, Safety And Tolerability Study Of 2 Dose Levels Of Liposomal Amikacin For Inhalation (Arikayce™) In Patients With Bronchiectasis Complicated By Chronic Infection Due To Pseudomonas Aeruginosa.

Brief Summary

      This is a study to determine the safety and tolerability of 28 days of daily dosing of two
      doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and
      chronic infection due to Pseudomonas infection.
    

Detailed Description

      Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by
      permanent dilation, microbial infection, a persistent inflammatory response with the release
      of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis
      varies, but the presence of microbial infection and a persistent inflammatory response is
      typical of the disease. The chronic nature of the infection and the associated considerable
      morbidity provides the rationale for using aerosolized antibiotics for the treatment of
      bronchiectasis patients.

      This is a multi-national Phase 2 study of safety and tolerability of 28 days of daily dosing
      with two dose levels (280 mg and 560 mg) of Arikayce™ versus placebo in subjects with
      bronchiectasis and chronic Pseudomonas infection. Study subjects will be randomized to
      receive either study drug or placebo by inhalation via a PARI eFlow® nebulizer. Each subject
      will complete 28 days of daily dosing. All study subjects will be followed for microbiologic
      activity for 14 days after completion of treatment and for safety for 28 days post completion
      of study treatment.

      The total study duration will be 56 days, with the screening visit occurring within the
      preceding 14 days prior to study day 1. At Day 1 (baseline), subjects will be evaluated at
      pre-dose and during the first 4-5 hours post-dose. Subjects will return at Week 2 (day 14)
      after start of treatment and at the end of Week 4 (Day 28) treatment period to determine
      safety and efficacy of Arikayce™. Subjects will be followed up on study Days 42 and 56 (about
      2 and 4 weeks after end of treatment) for safety determination. After completion of this
      study, subjects will be followed up for an additional 6 months via phone contacts and records
      review, if hospitalized or treated for pulmonary exacerbation (under the extension protocol).

      Clinical laboratory parameters, audiology testing, clinical adverse events and pulmonary
      function will be evaluated for all study subjects in order to determine the qualitative and
      quantitative safety and tolerability of Arikayce™ compared to placebo. Serum, urine and
      sputum specimens will be collected at periodic intervals to assess pharmacokinetics (PK) in
      subjects who consent for the PK portion of the study. Additionally, sputum samples will be
      collected to determine changes in bacterial density. Total Pulmonary Symptom Severity Score
      (PSSS) will be assessed, and respiratory quality of life will be evaluated by using the St.
      George's Respiratory Questionnaire (SGRQ). Arikace™,Arikayce™, Liposomal Amikacin for
      Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used
      interchangeably throughout this study and the other studies evaluating amikacin liposome
      inhalation suspension.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment

Secondary Outcome

 Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.

Condition

Bronchiectasis

Intervention

280 mg Arikayce™

Study Arms / Comparison Groups

 Cohort 1 - 280 mg Arikayce™
Description:  Subjects in this arm of the cohort 1 will receive 280 mg of Arikayce™

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

64

Start Date

June 24, 2008

Completion Date

May 11, 2009

Primary Completion Date

May 11, 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female study subjects≥ 18 years of age

          -  Confirmed diagnosis of multi-focal bronchiectasis in two or more lung segments by HRCT
             of the chest

          -  History of chronic infection with P. aeruginosa

          -  Confirmation of infection with P. aeruginosa at screening

          -  SaO2 ≥ 90% at Screening while breathing room air

          -  Ability to comply with study medication use, study visits, and study procedures as
             judged by the investigator

          -  Ability to produce at least 0.5 grams sputum or be willing to undergo an induction to
             produce sputum for clinical evaluation

        Key Exclusion Criteria:

          -  Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted at Screening

          -  Patients with hemoptysis of ≥60 mL within 4 weeks prior to screening

          -  Bronchiectasis due to cystic fibrosis (CF), bronchopulmonary Aspergillus, aspiration
             of foreign body, or secondary to lung compression from tumors

          -  History of non-tuberculous mycobacterial and/or Aspergillus infection requiring
             treatment or treated within 2 years prior to screening

          -  Pulmonary tuberculosis requiring treatment or treated within two years prior to
             screening

          -  History of Lung transplantation

          -  Use of any inhalation or systemic antibiotics (IV antibiotics, or oral antibiotics)
             within 4 weeks prior to Study Day 1

          -  Evidence of biliary cirrhosis with portal hypertension

          -  Smoking tobacco or any substance within 6 months prior to screening, and throughout
             the study

          -  History of alcohol, medication, or illicit drug abuse within the 1 year prior to
             screening
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gina Eagle, MD, , 

Location Countries

Bulgaria

Location Countries

Bulgaria

Administrative Informations


NCT ID

NCT00775138

Organization ID

TR02-107


Responsible Party

Sponsor

Study Sponsor

Insmed Incorporated


Study Sponsor

Gina Eagle, MD, Study Director, Insmed Incorporated


Verification Date

June 2019