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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT01055847

Collaborator

Salus Pharma, Inc. (Industry)

105

Enrollment

Locations

Arms

Duration (Months)

5.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis CF Lung Infection Pseudomonas Aeruginosa	Drug: Aztreonam for Inhalation (AI) Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Sep 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AI 75 mg Aztreonam for Inhalation 75 mg twice daily	Drug: Aztreonam for Inhalation (AI) Aztreonam for Inhalation Other Names: AI
Experimental: AI 225 mg Aztreonam for Inhalation 225 mg twice daily	Drug: Aztreonam for Inhalation (AI) Aztreonam for Inhalation Other Names: AI
Placebo Comparator: Placebo Placebo	Drug: Placebo Saline Placebo

Arm

Intervention/Treatment

Experimental: AI 75 mg

Aztreonam for Inhalation 75 mg twice daily

Drug: Aztreonam for Inhalation (AI)

Aztreonam for Inhalation

Other Names:

Experimental: AI 225 mg

Aztreonam for Inhalation 225 mg twice daily

Drug: Aztreonam for Inhalation (AI)

Aztreonam for Inhalation

Other Names:

Placebo Comparator: Placebo

Placebo

Drug: Placebo

Saline Placebo

Outcome Measures

Primary Outcome Measures

Change in FEV1 from Baseline to Day 14 [14 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts 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).
1. 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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Los Angeles	California	United States	90027
2	Orange	California	United States	92868
3	San Diego	California	United States	92103-8376
4	Stanford	California	United States	94305
5	Denver	Colorado	United States	80218
6	Gainsville	Florida	United States	32610
7	Orlando	Florida	United States	32806
8	Boston	Massachusetts	United States	02114
9	Ann Arbor	Michigan	United States	48109-0212
10	Omaha	Nebraska	United States	68198-5190
11	Chapel Hill	North Carolina	United States	27514
12	Cleveland	Ohio	United States	44106
13	Columbus	Ohio	United States	43205-2696
14	Dayton	Ohio	United States	45404
15	Philadelphia	Pennsylvania	United States	19129
16	Charleston	South Carolina	United States	29425
17	Houston	Texas	United States	77030
18	Salt Lake City	Utah	United States	84132
19	Seattle	Washington	United States	98105
20	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

Gilead Sciences
Salus Pharma, Inc.

Investigators

Principal Investigator: Ronald L Gibson, Jr., MD, Children's Hospital and Regional Medica Center, Seattle, WA
Principal Investigator: George Retsch-Bogart, MD, University of North Carolina Hospitals, Chapel Hill, NC