Clinical trial NCT01055847: Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
Official title: A Blinded, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam for Inhalation (AI) in Cystic Fibrosis Patient With Lung Disease Due to P. Aeruginosa Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
CF
Lung Infection
Pseudomonas Aeruginosa
Keywords: cystic fibrosis
CF
aztreonam
lung infection
Pseudomonas aeruginosa
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Salus Pharma, Inc.
First posted: 2010-01-26
Enrollment: 105
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.

Detailed description: This is multicenter placebo-controlled study evaluating the safety and efficacy of a 14-day treatment of AI at two dosage levels as compared to placebo, given twice daily, in CF patients with P. aeruginosa lung infection, delivered by the eFlow investigational nebulizer.

Eligibility criteria: Inclusion Criteria:

* Written informed consent prior to the performance of any study related procedures.
* 13 years of age and above.
* Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for ΔF508 genetic mutation or heterozygosity for two well characterized mutations.
* Ability to perform pulmonary function tests.
* FEV1 ≥ 40% predicted at Visit 1 (Screening).
* SaO2 ≥ 90% at Visit 1 (Screening).
* P. aeruginosa present in sputum at Visit 1 (Screening).
* Ability to expectorate sputum on a daily basis.

Exclusion Criteria:

* Administration of any antibiotic with antipseudomonal activity by any route within 56 days prior to Visit 1 (Screening).
* Administration of any investigational drug or device within 28 days of Visit 1 (Screening) and within 6 half-lives of the investigational drug.
* Oral corticosteroids in doses exceeding 10 mg per day or 20 mg every other day.
* History of sputum culture or throat swab culture yielding B. cepacia in the previous two years.
* Current daily continuous oxygen supplementation or requirement for more than 2 L/min at night.
* Known local or systemic hypersensitivity to monobactam antibiotics.
* Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 7 days prior to Visit 1 (Screening).
* Changes in physiotherapy technique or schedule within 7 days prior to Visit 1 (Screening).
* History of lung transplantation.
* A chest radiograph at Visit 1 (Screening) or within the previous 90 days of Screening, with abnormalities indicating a significant acute finding (eg, lobar infiltrate and atelectasis, pneumothorax, or pleural effusion).
* Abnormal renal or hepatic function or serum chemistry at Visit 1 (Screening):

  * AST, ALT \> 2.5 times upper limit of normal range.
  * Creatinine \> 1.5 times upper limit of normal range.
* Positive pregnancy test. All women of childbearing potential will be tested.
* Female of childbearing potential who is lactating or is not practicing acceptable method of birth control (eg, hormonal or barrier methods, or IUD).
* Findings at Visit 1 (Screening) that, in the investigator's opinion, would compromise the safety of the patient or the quality of the study data.

Primary outcomes:
measure: Change in FEV1 from Baseline to Day 14
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Gainsville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Chapel Hill
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Children's Hospital and Regional Medica Center, Seattle, WA
name: Ronald L Gibson, Jr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina Hospitals, Chapel Hill, NC
name: George Retsch-Bogart, MD
role: PRINCIPAL_INVESTIGATOR
References: