Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection

Phase 2

Completed

• Conditions: Cystic Fibrosis; CF; Lung Infection; Pseudomonas Aeruginosa
• Interventions: Drug: Aztreonam for Inhalation (AI); Drug: Placebo

• Registration Number: NCT01055847
• Lead Sponsor: Gilead Sciences

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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-08
• Study Completion: 2004-09
• Status Verified: 2010-01
• Study First Submitted: 2010-01-23
• Study First Submitted QC: 2010-01-25
• Last Update Submitted: 2010-01-25
• Study First Posted: 2010-01-26
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI 75 mg	Aztreonam for Inhalation (AI)	Aztreonam for Inhalation 75 mg twice daily
AI 225 mg	Aztreonam for Inhalation (AI)	Aztreonam for Inhalation 225 mg twice daily
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change in FEV1 from Baseline to Day 14	14 Days