Cystic Fibrosis Clinical Trial
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
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences | Salus Pharma, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in FEV1 from Baseline to Day 14 | 14 Days | No |
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