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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01055847
Other study ID # CP-AI-003
Secondary ID
Status Completed
Phase Phase 2
First received January 23, 2010
Last updated January 25, 2010
Start date June 2003
Est. completion date September 2004

Study information

Verified date January 2010
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date September 2004
Est. primary completion date August 2004
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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 ?F508 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Aztreonam for Inhalation (AI)
Aztreonam for Inhalation
Placebo
Saline Placebo

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Gilead Sciences Salus Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in FEV1 from Baseline to Day 14 14 Days No
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