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A Study to Determine the Safety and Tolerability of Arikace™ Versus Placebo... | Completed
A Study to Determine the Safety and... | Completed
A Study to Determine the Safety and Tolerability of Arikace™ Versus Placebo in Patients Who Have Bronchiectasis.

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Medical Conditions
  • Bronchiectasis
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT00775138
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280mg and 560mg) of Arikace™ versus placebo in patients who have Bronchiectasis.
Research Details
  • 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 Arikace™ versus placebo in subjects with bronchiectasis (BR) 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 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 2 weeks (day 14) after start of treatment and at the end of 4 weeks (Day 28) treatment period to determine safety and, efficacy of Arikace™. Subjects will be followed up at 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 Arikace™ compared to placebo. Serum, urine and sputum specimens will be collected at periodic intervals to assess PK in subjectswho 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 will be assessed, and Respiratory quality of life will be evaluated by using the St. George's Respiratory Questionnaire (SGRQ).
Phase
Phase 1/Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Arikace 280 mg, Drug : Arikace 560 mg, Drug : Matching Placebo

Study Arm Groups : Arikace at 280 mg, Arikace at 560 mg, Matching placebo (280mg or 560mg)

Intervention Type
See Interventions above
Primary Outcome Measures
    Treatment emergent adverse events up to end of treatment; 28 days; Treatment emergent marked laboratory abnormalities up to 28 days after study medication discontinuation; 56 days; Treatment emergent pulmonary function test (PFT) abnormalities post-dose for acute tolerability assessment; 28 days; Treatment emergent pulmonary function test (PFT) abnormalities up to end of treatment; 56 days; Adverse events leading to permanent discontinuation of study medication; 28 days; Serious adverse events up to 28 days after study medication discontinuation; 28 days
Secondary Outcome Measures
    To access pharmacokinetics (PK) of Arikace™ in serum and urine, and evaluate sputum amikacin levels; 28 days dosing; To evaluate change in Pulmonary function; 28 days dosing; To evaluate change in density of Pseudomonas aeruginosa in sputum; 28 days dosing; To evaluate time to and duration of systemic anti-Pseudomonal rescue therapy; 28 days dosing; To evaluate change in St. George's Respiratory Questionnaire measurements; 28 days dosing
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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

    Exclusion Criteria:

    - Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted at 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
Cambridge
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Bulgaria, Greece, Hungary, India, Poland, Serbia, Ukraine, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Placebo Controlled, Randomized, Parallel Cohort, Safety And Tolerability Study Of 2 Dose Levels Of Liposomal Amikacin For Inhalation (Arikace™) In Patients With Bronchiectasis Complicated By Chronic Infection Due To Pseudomonas Aeruginosa
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
TR02-107
Sponsor(s)
Insmed Incorporated
Key Dates

Recruitment Start Date

Jun 2008

Recruitment End Date

May 2009

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

15 Oct 2008

Date updated in source

29 Sep 2016