Cystic FibrosisPhase 2NCT01055847
Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
A Phase 2 study testing Aztreonam for Inhalation (AI) in people with Cystic Fibrosis and CF, run by Gilead Sciences at 20 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cystic Fibrosis, CF, Lung Infection
- What is being tested?
- Aztreonam for Inhalation (AI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 20 sitesUnited States
- Study dates
- Jun 2003to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Ann Arbor, Michigan, 48109-0212
Study site
Boston, Massachusetts, 02114
Study site
Chapel Hill, North Carolina, 27514
Study site
Charleston, South Carolina, 29425
Study site
Cleveland, Ohio, 44106
Study site
Columbus, Ohio, 43205-2696
Study site
Dayton, Ohio, 45404
Study site
Denver, Colorado, 80218
Study site
Gainsville, Florida, 32610
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90027
Study site
Madison, Wisconsin, 53792
Study site
Omaha, Nebraska, 68198-5190
Study site
Orange, California, 92868
Study site
Orlando, Florida, 32806
Study site
Philadelphia, Pennsylvania, 19129
Study site
Salt Lake City, Utah, 84132
Study site
San Diego, California, 92103-8376
Study site
Seattle, Washington, 98105
Study site
Stanford, California, 94305
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis, CF, Lung Infection, Pseudomonas Aeruginosa
- Being tested
- Aztreonam for Inhalation (AI), Placebo
- Keywords
- cystic fibrosis, CF, aztreonam, lung infection, Pseudomonas aeruginosa
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aztreonam for Inhalation (AI)Drug
Also called AI
Aztreonam for Inhalation
PlaceboDrug
Saline Placebo
| Study group | Role | What they receive |
|---|---|---|
| AI 75 mg | Experimental | Aztreonam for Inhalation 75 mg twice daily Receives: Drug: Aztreonam for Inhalation (AI) |
| AI 225 mg | Experimental | Aztreonam for Inhalation 225 mg twice daily Receives: Drug: Aztreonam for Inhalation (AI) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 from Baseline to Day 14
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJun 2003
- Primary completionAug 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Salus Pharma, Inc.
- Investigators
- Ronald L Gibson, Jr., MD, Principal investigator, Children's Hospital and Regional Medica Center, Seattle, WAGeorge Retsch-Bogart, MD, Principal investigator, University of North Carolina Hospitals, Chapel Hill, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055847
- Sponsor's protocol ID
- CP-AI-003
- Status last verified
- Jan 2010
- First submitted
- 23 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01055847
- Acronym / sponsor ID
- CP-AI-003
- Conditions
- Cystic Fibrosis, CF, Lung Infection, Pseudomonas Aeruginosa
- Keywords
- cystic fibrosis, CF, aztreonam, lung infection, Pseudomonas aeruginosa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Salus Pharma, Inc.
- Study start
- Jun 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI 75 mg | Experimental | Drug: Aztreonam for Inhalation (AI)Aztreonam for Inhalation 75 mg twice daily |
| AI 225 mg | Experimental | Drug: Aztreonam for Inhalation (AI)Aztreonam for Inhalation 225 mg twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aztreonam for Inhalation (AI)Also: AIAztreonam for Inhalation | Drug | AI 225 mg, AI 75 mg |
| PlaceboSaline Placebo | Drug | Placebo |
Primary outcome
Change in FEV1 from Baseline to Day 14
Time frame: 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald L Gibson, Jr., MD principal investigator
Children's Hospital and Regional Medica Center, Seattle, WA
George Retsch-Bogart, MD principal investigator
University of North Carolina Hospitals, Chapel Hill, NC
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aztreonam for Inhalation (AI) in people with Cystic Fibrosis and CF, run by Gilead Sciences at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 from Baseline to Day 14 (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2010.