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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: CF; Lung Infection; Cystic Fibrosis; Pseudomonas Aeruginosa

Treatments: Drug: Aztreonam for Inhalation (AI); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01055847

CP-AI-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups, including a placebo group

AI 75 mg

Experimental group

Description:

Aztreonam for Inhalation 75 mg twice daily

Treatment:

Drug: Aztreonam for Inhalation (AI)

AI 225 mg

Experimental group

Description:

Aztreonam for Inhalation 225 mg twice daily

Treatment:

Drug: Aztreonam for Inhalation (AI)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo