--- title: Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection nct_id: NCT01055847 overall_status: COMPLETED phase: PHASE2 sponsor: Gilead Sciences study_type: INTERVENTIONAL primary_condition: Cystic Fibrosis countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01055847.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01055847" ct_last_update_post_date: 2010-01-26 last_seen_at: "2026-05-12T06:43:12.284Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT01055847](https://clinicaltrials.gov/study/NCT01055847) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 105 - **Lead Sponsor:** Gilead Sciences - **Collaborators:** Salus Pharma, Inc. - **Conditions:** Cystic Fibrosis, CF, Lung Infection, Pseudomonas Aeruginosa - **Start Date:** 2003-06 - **Completion Date:** 2004-09 - **CT.gov Last Update:** 2010-01-26 ## 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 - **Minimum age:** 13 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **AI 75 mg** (EXPERIMENTAL) — Aztreonam for Inhalation 75 mg twice daily - **AI 225 mg** (EXPERIMENTAL) — Aztreonam for Inhalation 225 mg twice daily - **Placebo** (PLACEBO_COMPARATOR) — Placebo ## Interventions - **Aztreonam for Inhalation (AI)** (DRUG) — Aztreonam for Inhalation - **Placebo** (DRUG) — Saline Placebo ## Primary Outcomes - **Change in FEV1 from Baseline to Day 14** _(time frame: 14 Days)_ ## Locations (20) - Los Angeles, California, United States - Orange, California, United States - San Diego, California, United States - Stanford, California, United States - Denver, Colorado, United States - Gainsville, Florida, United States - Orlando, Florida, United States - Boston, Massachusetts, United States - Ann Arbor, Michigan, United States - Omaha, Nebraska, United States - Chapel Hill, North Carolina, United States - Cleveland, Ohio, United States - Columbus, Ohio, United States - Dayton, Ohio, United States - Philadelphia, Pennsylvania, United States - Charleston, South Carolina, United States - Houston, Texas, United States - Salt Lake City, Utah, United States - Seattle, Washington, United States - Madison, Wisconsin, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|los angeles|california|united states` — added _(2026-05-12)_ - `locations.|orange|california|united states` — added _(2026-05-12)_ - `locations.|san diego|california|united states` — added _(2026-05-12)_ - `locations.|stanford|california|united states` — added _(2026-05-12)_ - `locations.|denver|colorado|united states` — added _(2026-05-12)_ - `locations.|gainsville|florida|united states` — added _(2026-05-12)_ - `locations.|orlando|florida|united states` — added _(2026-05-12)_ - `locations.|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.|chapel hill|north carolina|united states` — added _(2026-05-12)_ - `locations.|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.|dayton|ohio|united states` — added _(2026-05-12)_ - `locations.|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.|houston|texas|united states` — added _(2026-05-12)_ - `locations.|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.|seattle|washington|united states` — added _(2026-05-12)_ - `locations.|madison|wisconsin|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01055847.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01055847* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*