Cystic FibrosisPhase 3AIR-CF4NCT00712166
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
A Phase 3 study testing AZLI 75 mg three times daily (TID) in people with Cystic Fibrosis and Lung Infection, run by Gilead Sciences at 40 sites in 3 countries.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second [FEV1] >75% predicted, and Pseudomonas aeruginosa (PA) infection. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
- What is being tested?
- AZLI 75 mg three times daily (TID)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 40 sitesin 3 countries
- Study dates
- May 2008to Aug 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants ≥ 6 years of age
- Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test
- Two well characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- Abnormal nasal potential difference
- PA present in expectorated sputum or throat swab culture at Visit 1 OR documented PA in 2 expectorated sputum or throat swab cultures within the 12 months prior to Visit 1 (one of the previous PA positive cultures must have been no more than 3 months prior to Visit 1)
Show all 18Show fewer
- FEV1 > 75% predicted at Visit 1
- Participants must have exhibited two or more of the following chronic and/or intermittent CF symptoms, for a minimum of 28 days prior to randomization and with no worsening of symptoms within 7 days prior to randomization:
- Chest congestion
- Daily cough
- Productive cough
- Wheezing
- Trouble breathing
- Nocturnal wakening due to coughing
- Participants (and parent/guardian as required) had to be able to provide written informed consent/assent prior to any study related procedures
- Females of childbearing potential had to have a negative urine pregnancy test at Visit 1
- Ability to perform reproducible pulmonary function tests
- In the opinion of the Investigator, the participant did not require immediate antipseudomonal antibiotic intervention to treat an impending exacerbation, and the participant's condition was stable enough to enroll in the study
Who cannot join
- Administration of any investigational drug or device within 28 days prior to Visit 1 or within 6 half-lives of the investigational drug (whichever was longer)
- Administration of any IV, oral, or inhaled antipseudomonal antibiotic within 28 days prior to Visit 1
- Known local or systemic hypersensitivity to monobactam antibiotics
- Inability to tolerate short-acting bronchodilator (BD) use at least TID
- Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1
- Changes in or initiation of chronic hypertonic saline treatment within 28 days prior to Visit 1
Show all 16Show fewer
- Changes in or initiation of dornase alfa within 28 days prior to Visit 1
- Changes in antimicrobial, BD, or corticosteroid medications within 7 days prior to Visit 1
- Changes in physiotherapy technique or schedule within 7 days prior to Visit 1
- History of lung transplantation
- History of participation (enrollment) in any prior clinical studies with AZLI
- A chest radiograph at Visit 1 (or within the previous 180 days of Visit 1), with abnormalities indicating a significant acute finding (e.g., lobar infiltrate and atelectasis, pneumothorax, or pleural effusion); a chest radiograph obtained and interpreted between Visits 1 and 2 was also acceptable for determining eligibility
- Positive urine pregnancy test at Visit 1; all women of childbearing potential were to be tested
- Females of childbearing potential who were lactating or were not (in the opinion of the investigator) practicing an acceptable method of birth control; female participants who utilized hormonal contraceptives as their birth control method must have used the same method for at least 3 months before study dosing
- Participant was being assessed at Visit 1 by the investigator for an acute change in respiratory symptoms
- Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would have interfered with participant treatment, assessment, or compliance with the protocol
Trial locations and contacts
40 sites in 3 countries.
40 sites in 3 countries
United States34 sites
Albany Medical College
Albany, New York
University of Michigan Health System
Ann Arbor, Michigan
The Children's Hospital
Aurora, Colorado
Children's Hospital, Boston
Boston, Massachusetts
Tufts Medical Center, Pediatric Pulmonary Clinic
Boston, Massachusetts
The Lung & Cystic Fibrosis Center, University of Buffalo Pediatric Associates, Inc., Women & Children's Hospital of Buffalo
Buffalo, New York
Children's Memorial Hospital
Chicago, Illinois
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio
Nationwide Children's Hospital
Columbus, Ohio
The Children's Hospital of Michigan, Detroit Medical Center
Detroit, Michigan
Connecticut Children's Medical Center
Hartford, Connecticut
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania
Baylor College of Medicine
Houston, Texas
Indiana University, Outpatient Clinical Research Facility
Indianapolis, Indiana
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana
Nemours Children's Clinic
Jacksonville, Florida
Children's Lung Specialists
Las Vegas, Nevada
Arkansas Children's Hospital
Little Rock, Arkansas
University of Arkansas for Medical Sciences, Division of Pulmonary and Critical Care Medicine
Little Rock, Arkansas
The Minnesota CF Center, University of Minnesota Medical Center
Minneapolis, Minnesota
Long Island Jewish Medical Center
New Hyde Park, New York
Kaiser Permanente
Oakland, California
Santiago Reyes, MD
Oklahoma City, Oklahoma
Children's Hospital of Orange County
Orange, California
Nemours Children's Clinic
Orlando, Florida
Drexel University College of Medicine, Pulmonary Associates
Philadelphia, Pennsylvania
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania
Phoenix Children's Hospital
Phoenix, Arizona
Primary Children's Medical Center
Salt Lake City, Utah
Children's Hospital and Regional Medical Center
Seattle, Washington
SUNY Upstate Medical University
Syracuse, New York
Toledo Children's Hospital/Toledo Hospital, Cystic Fibrosis Research Center
Toledo, Ohio
University Medical Center
Tucson, Arizona
Australia5 sites
The Prince Charles Hospital, Adult Cystic Fibrosis Centre
Chermside, Queensland
Respiratory Medicine, Royal Children's Hospital
Herston, Queensland
Child and Adolescent Health Services, Princess Margaret Hospital
Perth, Western Australia
Department of Respiratory Medicine, The Children's Hospital at Westmead
Westmead, New South Wales
Department of Respiratory Medicine, Westmead Hospital
Westmead, New South Wales
About this study
Official title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second [FEV1] >75% predicted, and Pseudomonas aeruginosa (PA) infection.
Read the detailed description
CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic aztreonam and administered three times a day using the PARI eFlow® electronic nebulizer, in CF patients with PA and mild lung disease.
In this study, participant eligibility was assessed at a screening visit that occurred up to 14 days prior to the baseline visit (Day 0). Those participants who met eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI or placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow up visit 14 days after the last dose of the trial drug (Day 42).
- Conditions
- Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
- Being tested
- AZLI 75 mg three times daily (TID), Placebo three times daily (TID)
- Keywords
- cystic fibrosis, pseudomonas aeruginosa, lung infection, CFQ-R, inhaled antibiotic, aztreonam lysine
- 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.
AZLI 75 mg three times daily (TID)Drug
Placebo three times daily (TID)Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo three times daily (TID) | Placebo comparator | Not described Receives: Drug: Placebo three times daily (TID) |
| AZLI 75 mg three times daily (TID) | Experimental | Not described Receives: Drug: AZLI 75 mg three times daily (TID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Measured: Day 0 to Day 28
Secondary outcomes (7)
Change From Baseline in CFQ-R RSS Score at Day 14
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Measured: Day 0 to Day 14
Change From Baseline in CFQ-R RSS Score at Day 42
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Measured: Day 0 to Day 42
Change From Baseline in CFQ-R Physical Functioning Domain Score
The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0 (baseline), 14, 28, and 42 (the last study visit). The endpoint was change from baseline in the physical functioning domain (e.g., ability to walk and engage in physical activities) of the CFQ-R at Day 28 (range of scores: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R physical functioning domain score and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Measured: Day 0 to Day 28
Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study
The number of participants requiring additional antipseudomonal antibiotics (oral, intravenous [IV], or by inhalation), the time to use of these antibiotics, and the reasons for use was recorded. A binary variable was defined to indicate whether the participants needed any antipseudomonal antibiotics that were non-study drug via the oral, IV, or inhalation route between Day 0 (Baseline Visit) and Day 42 (Visit 5). Fisher's Exact Test was implemented on the intent-to-treat (ITT) and per protocol analysis sets to detect treatment effects on need for additional antipseudomonal antibiotics.
Measured: Day 0 to Day 42
Number of Participants Hospitalized During Study
Hospitalization was defined as any hospital admission lasting for more than 1 calendar day that had been recorded as a serious adverse event (SAE) on the electronic case report form (eCRF). Binary variables were defined to indicate whether participants experienced any hospitalization. Number of hospitalizations was summarized by treatment group.
Measured: Day 0 to Day 42
Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28
Sputum samples were collected at all study visits for quantitative and qualitative culture for PA. Sputum PA density was quantified by logarithm transformation of the CFU value with base 10. Change from baseline in sputum PA density was calculated as the difference between the log10 CFU values at Day 28 (Visit 4) and the baseline value. Missing data was not imputed. Baseline log10 CFU and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Measured: Day 0 to Day 28
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted
Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested by the ANCOVA model using the ITT analysis set. Baseline FEV1 percent predicted and age group (<18 vs. >=18 years) were included as covariates in the analysis.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claire Wainwright, MD, Principal investigator, Royal Children's Hospital, Brisbane, QLD, AustraliaRon Gibson, MD, Principal investigator, Children's Hospital & Regional Medical Center, Seattle WA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712166
- Sponsor's protocol ID
- GS-US-205-0117
- Acronym
- AIR-CF4
- Status last verified
- Nov 2010
- First submitted
- 7 Jul 2008
- Last updated
- 20 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wainwright CE, Quittner AL, Geller DE, Nakamura C, Wooldridge JL, Gibson RL, Lewis S, Montgomery AB. Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. J Cyst Fibros. 2011 Jul;10(4):234-42. doi: 10.1016/j.jcf.2011.02.007. Epub 2011 Mar 26.
PubMed 21441078
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
- ClinicalTrials.gov ID
- NCT00712166
- Acronym / sponsor ID
- AIR-CF4 / GS-US-205-0117
- Conditions
- Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
- Keywords
- cystic fibrosis, pseudomonas aeruginosa, lung infection, CFQ-R, inhaled antibiotic, aztreonam lysine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Posted 20 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second [FEV1] >75% predicted, and Pseudomonas aeruginosa (PA) infection.
Detailed description
CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic aztreonam and administered three times a day using the PARI eFlow® electronic nebulizer, in CF patients with PA and mild lung disease.
In this study, participant eligibility was assessed at a screening visit that occurred up to 14 days prior to the baseline visit (Day 0). Those participants who met eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI or placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow up visit 14 days after the last dose of the trial drug (Day 42).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo three times daily (TID) | Placebo comparator | Drug: Placebo three times daily (TID) |
| AZLI 75 mg three times daily (TID) | Experimental | Drug: AZLI 75 mg three times daily (TID) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Participants ≥ 6 years of age
- Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- PA present in expectorated sputum or throat swab culture at Visit 1 OR documented PA in 2 expectorated sputum or throat swab cultures within the 12 months prior to Visit 1 (one of the previous PA positive cultures must have been no more than 3 months prior to Visit 1)
- FEV1 > 75% predicted at Visit 1
- Participants must have exhibited two or more of the following chronic and/or intermittent CF symptoms, for a minimum of 28 days prior to randomization and with no worsening of symptoms within 7 days prior to randomization:
Key exclusion criteria (16 listed)
- Administration of any investigational drug or device within 28 days prior to Visit 1 or within 6 half-lives of the investigational drug (whichever was longer)
- Administration of any IV, oral, or inhaled antipseudomonal antibiotic within 28 days prior to Visit 1
- Known local or systemic hypersensitivity to monobactam antibiotics
- Inability to tolerate short-acting bronchodilator (BD) use at least TID
- Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1
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 |
|---|---|---|
| AZLI 75 mg three times daily (TID) | Drug | AZLI 75 mg three times daily (TID) |
| Placebo three times daily (TID) | Drug | Placebo three times daily (TID) |
Primary outcome
Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28
Time frame: Day 0 to Day 28
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.
7 secondary outcomes
Change From Baseline in CFQ-R RSS Score at Day 14
Time frame: Day 0 to Day 14
Change From Baseline in CFQ-R RSS Score at Day 42
Time frame: Day 0 to Day 42
Change From Baseline in CFQ-R Physical Functioning Domain Score
Time frame: Day 0 to Day 28
Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study
Time frame: Day 0 to Day 42
Number of Participants Hospitalized During Study
Time frame: Day 0 to Day 42
Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28
Time frame: Day 0 to Day 28
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted
Time frame: Day 0 to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21441078Wainwright CE, Quittner AL, Geller DE, Nakamura C, Wooldridge JL, Gibson RL, Lewis S, Montgomery AB. Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. J Cyst Fibros. 2011 Jul;10(4):234-42. doi: 10.1016/j.jcf.2011.02.007. Epub 2011 Mar 26.
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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.
Claire Wainwright, MD principal investigator
Royal Children's Hospital, Brisbane, QLD, Australia
Ron Gibson, MD principal investigator
Children's Hospital & Regional Medical Center, Seattle WA, USA
40 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AZLI 75 mg three times daily (TID) in people with Cystic Fibrosis and Lung Infection, run by Gilead Sciences at 40 sites in 3 countries.
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 18 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 20 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Australia, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (time frame: Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712166, which also lists 1 linked publication.
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 20 Dec 2010; AzTrials last refreshed its copy on 26 Oct 2026.