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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Blinded, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam for Inhalation (AI) in Cystic Fibrosis Patient With Lung Disease Due to P. Aeruginosa Infection

Conditions
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Cystic Fibrosis, CF, Lung Infection, Pseudomonas Aeruginosa

Intervention / Treatment
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* Drug: Aztreonam for Inhalation (AI)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI 75 mg<br>Aztreonam for Inhalation 75 mg twice daily | Drug: Aztreonam for Inhalation (AI)<br>* Aztreonam for Inhalation<br>* Other names: AI;|
| Experimental: AI 225 mg<br>Aztreonam for Inhalation 225 mg twice daily | Drug: Aztreonam for Inhalation (AI)<br>* Aztreonam for Inhalation<br>* Other names: AI;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Saline Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 from Baseline to Day 14 |  | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, CF, aztreonam, lung infection, Pseudomonas aeruginosa