Cystic FibrosisPhase 3NCT00757237
Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa
A Phase 3 study testing Aztreonam for Inhalation Solution (AZLI) and Tobramycin Inhalation Solution (TIS) in people with Cystic Fibrosis, run by Gilead Sciences at 92 sites in 13 countries.
Trial summary
The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary 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
- What is being tested?
- Aztreonam for Inhalation Solution (AZLI) and Tobramycin Inhalation Solution (TIS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 92 sitesin 13 countries
- Study dates
- Aug 2008to Nov 2010
- 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
- Males or females aged 6 years and older
- Subjects with CF as diagnosed by one of the following: documented sweat chloride >= 60 mEq/L by quantitative pilocarpine iontophoresis test, or documented sweat sodium >= 60 mmol/L, or 2 well characterized genetic mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, or abnormal nasal potential difference with accompanying symptoms characteristic of CF
- Documented PA in an expectorated sputum or throat swab culture within 3 months prior to Visit 1 or at Visit 1
- Subjects must be able to provide written informed consent/assent prior to any study related procedures; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure
- Subjects must have received previous treatment with aerosolized antibiotics without demonstration of drug intolerance
- FEV1 <= 75% predicted at Visit 1
- Ability to perform reproducible pulmonary function tests
- Chest radiograph at Visit 1 without significant acute findings (eg, infiltrates [lobar or diffuse interstitial], pleural effusion, pneumothorax); or chest radiograph or magnetic resonance image (MRI) obtained within the 180 days prior to Visit 1 without acute findings and no significant intercurrent illness; chronic, stable findings (eg, chronic scarring or atelectasis) are allowed
Who cannot join
- Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day
- History of sputum or throat swab culture yielding B. cepacia in the previous 2 years
- Current requirement for daily continuous oxygen supplementation or requirement for more than 2 L/minute at night
- Administration of any investigational drug or device within 28 days of Visit 1 or within 6 half-lives of the investigational drug (whichever is longer)
- Known local or systemic hypersensitivity to monobactam antibiotics
- Known allergies/intolerance to tobramycin
Show all 16Show fewer
- Inability to tolerate inhalation of a short acting beta agonist
- Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1
- Administration of antipseudomonal antibiotics by inhalation, intravenous or oral routes within the 14 days prior to Randomization/Visit 2
- Changes in antimicrobial, bronchodilator (BD), dornase alfa, 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
- Abnormal renal or hepatic function or serum chemistry at Visit 1, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 5 times upper limit of normal range (ULN) or creatinine > 2 times ULN
- Positive pregnancy test at Visit 1; all women of childbearing potential will be tested
- Female of childbearing potential who is lactating or is not (in the opinion of the investigator) practicing an acceptable method of birth control; female subjects who utilize hormonal contraceptives as one of their birth control methods must have used the same method for at least 3 months before study dosing
- Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol
Trial locations and contacts
92 sites in 13 countries.
92 sites in 13 countries
United States29 sites
Study site
Albany, New York, 12208
Study site
Anchorage, Alaska, 99508
Study site
Aurora, Colorado, 80045
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Boston, Massachusetts, 02115
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Charleston, South Carolina, 29425
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45229
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Columbia, Missouri, 65212
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Dayton, Ohio, 45404
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Denver, Colorado, 80206
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Glenview, Illinois, 60025
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Hershey, Pennsylvania, 17033
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Houston, Texas, 77030
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Las Vegas, Nevada, 89107
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New Hyde Park, New York, 11040
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Niles, Illinois, 60714
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Oklahoma City, Oklahoma, 73112
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Orange, California, 92868
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Orlando, Florida, 32801
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Philadelphia, Pennsylvania, 19102
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Philadelphia, Pennsylvania, 19104
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Phoenix, Arizona, 85006
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Richmond, Virginia, 23298
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Salt Lake City, Utah, 84132
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San Antonio, Texas, 78212
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Tampa, Florida, 33606
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Toledo, Ohio, 43606
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Tuscon, Arizona, 85724
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Wilmington, Delaware, 19803
France11 sites
Study site
Amiens, 80054
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Bordeaux, 33076
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Caen, 14000
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Créteil, 94000
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Lille, 59037
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Lisieux, 14100
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Montpellier, 34295
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Nice, 06202
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Paris, 75743
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Pessac, 33604
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Rennes, 35033
Germany11 sites
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Berlin, 123353
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Berlin, 13125
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Bochum, 44791
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Essen, 45122
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Essen, 45239
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Giessen, 35392
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Hamburg, 22763
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Leipzig, 04103
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Magdeburg, 39120
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Mainz, 55101
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München, 80336
Italy9 sites
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Ancona, 60123
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Catania, 95123
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Milan, 20122
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Naples, 80131
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Palermo, 90134
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Parma, 43100
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Rome, 00161
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Rome, 00165
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Verona, 37126
United Kingdom8 sites
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Belfast, BT9 7AB
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Cambridge, CB23 3RE
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Cardiff, CF64-2XX
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Leeds, LS9 7TF
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Liverpool, L14 3PE
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London, SW3 6NP
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Sheffield, West Yorkshire, S10 2TH
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Southampton, SO16 6YD
Belgium5 sites
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Antwerp, 2650
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Brussels, 1070
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Brussels, 1090
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Ghent, 9000
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Leuven, 3000
Ireland5 sites
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Dublin, 24
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Dublin, 4
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Dublin, 9
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Dublin
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Galway
Spain5 sites
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Madrid, 28009
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Madrid, 28034
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Madrid, 28041
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Madrid, 28046
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Málaga, 29011
Netherlands2 sites
Study site
Maastricht, 6229
Study site
The Hague, 2504 LN
Switzerland2 sites
Study site
Zurich, CH - 8032
Study site
Zurich, CH - 8091
About this study
Official title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)
The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.
Read the detailed description
Number of Subjects Planned: Approximately 240 randomized patients
Target Population: CF patients >= 6 years of age with stable pulmonary disease, who at study entry had a recent positive sputum culture for PA and had been previously treated with aerosolized antibiotics without demonstration of drug intolerance.
The randomized phase of this study, used for hypotheses testing, enrolled participants from both the United States (US) and EU. An open-label, single-arm extension was available for participants in the EU who completed at least one course of AZLI or TIS during the randomized portion of the study. These participants were eligible to receive 3 additional cycles of AZLI in a 28-day, intermittent, repeating treatment regimen. Results of the extension phase will be available the first quarter (Q1) of 2012.
Randomized Phase Study Design (US and EU): This was an open-label, multicenter, randomized, parallel group study. The study design consisted of 2 treatment arms of 28-day, intermittent, repeating treatment regimens: aztreonam for inhalation solution (AZLI) or tobramycin inhalation solution (TIS). The total study period was 26 weeks. The study schedule included 9 visits - Screening, Baseline, Day 14, Day 28, followed by visits every 28 days through the end of the study.
- Conditions
- Cystic Fibrosis
- Being tested
- Aztreonam for Inhalation Solution (AZLI), Tobramycin Inhalation Solution (TIS)
- Keywords
- aztreonam lysine, tobramycin inhalation solution, tobramycin nebuliser solution, cystic fibrosis, pseudomonas aeruginosa, lung infection, CFQ-R, inhaled antibiotic
- 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 Solution (AZLI)Drug
Also called aztreonam, AZLI, inhaled antibiotic
Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer.
Tobramycin Inhalation Solution (TIS)Drug
Also called tobramycin, TNS, inhaled antibiotic
Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling.
| Study group | Role | What they receive |
|---|---|---|
| AZLI 75 mg 3 times a day (TID) | Experimental | Not described Receives: Drug: Aztreonam for Inhalation Solution (AZLI) |
| TIS 300 mg 2 times a day (BID) | Active comparator | Not described Receives: Drug: Tobramycin Inhalation Solution (TIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28
Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.
Measured: Baseline and end of treatment Course 1 (Day 28)
Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses
Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.
Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set.
Measured: Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)
Secondary outcomes (4)
Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization
Spirometry was performed according to ATS guidelines. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an ANCOVA model-based method, using the population of participants with prior inhaled tobramycin use of >= 84 days in the previous 12 months.
Measured: Baseline and end of treatment Course 1 (Day 28)
Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization
Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.
Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by MMRM analysis using the population of participants with prior inhaled tobramycin use of >=84 days in the previous 12 months.
Measured: Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)
Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events
IV antipseudomonal antibiotic use for a respiratory event was determined through the adjudication of events by a sponsor-independent, blinded review committee.
Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.
Measured: Day 0 to Day 168 (end of study)
Time to First Respiratory Hospitalization
This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events.
Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF.
Time to first respiratory hospitalization was the number of days from baseline (Visit 2) to the date of first respiratory hospitalization or the date of study completion (last visit) /or early withdrawal if censored.
Measured: Day 0 to Day 168 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2010
- Study completionNov 2010
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
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc., ClinPhone, Inc., Covance
- Investigators
- Mark Bresnik, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757237
- Sponsor's protocol ID
- GS-US-205-0110
- Status last verified
- Jun 2011
- First submitted
- 22 Sep 2008
- Last updated
- 4 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group. Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.
PubMed 22985692
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)
- ClinicalTrials.gov ID
- NCT00757237
- Acronym / sponsor ID
- GS-US-205-0110
- Conditions
- Cystic Fibrosis
- Keywords
- aztreonam lysine, tobramycin inhalation solution, tobramycin nebuliser solution, cystic fibrosis, pseudomonas aeruginosa, lung infection, CFQ-R, inhaled antibiotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc., ClinPhone, Inc., Covance
- Study start
- Aug 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Posted 4 Jul 2011
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 assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.
Detailed description
Number of Subjects Planned: Approximately 240 randomized patients
Target Population: CF patients >= 6 years of age with stable pulmonary disease, who at study entry had a recent positive sputum culture for PA and had been previously treated with aerosolized antibiotics without demonstration of drug intolerance.
The randomized phase of this study, used for hypotheses testing, enrolled participants from both the United States (US) and EU. An open-label, single-arm extension was available for participants in the EU who completed at least one course of AZLI or TIS during the randomized portion of the study. These participants were eligible to receive 3 additional cycles of AZLI in a 28-day, intermittent, repeating treatment regimen. Results of the extension phase will be available the first quarter (Q1) of 2012.
Randomized Phase Study Design (US and EU): This was an open-label, multicenter, randomized, parallel group study. The study design consisted of 2 treatment arms of 28-day, intermittent, repeating treatment regimens: aztreonam for inhalation solution (AZLI) or tobramycin inhalation solution (TIS). The total study period was 26 weeks. The study schedule included 9 visits - Screening, Baseline, Day 14, Day 28, followed by visits every 28 days through the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZLI 75 mg 3 times a day (TID) | Experimental | Drug: Aztreonam for Inhalation Solution (AZLI) |
| TIS 300 mg 2 times a day (BID) | Active comparator | Drug: Tobramycin Inhalation Solution (TIS) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females aged 6 years and older
- Subjects with CF as diagnosed by one of the following: documented sweat chloride >= 60 mEq/L by quantitative pilocarpine iontophoresis test, or documented sweat sodium >= 60 mmol/L, or 2 well characterized genetic mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, or abnormal nasal potential difference with accompanying symptoms characteristic of CF
- Documented PA in an expectorated sputum or throat swab culture within 3 months prior to Visit 1 or at Visit 1
- Subjects must be able to provide written informed consent/assent prior to any study related procedures; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure
- Subjects must have received previous treatment with aerosolized antibiotics without demonstration of drug intolerance
Key exclusion criteria (16 listed)
- Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day
- History of sputum or throat swab culture yielding B. cepacia in the previous 2 years
- Current requirement for daily continuous oxygen supplementation or requirement for more than 2 L/minute at night
- Administration of any investigational drug or device within 28 days of Visit 1 or within 6 half-lives of the investigational drug (whichever is longer)
- Known local or systemic hypersensitivity to monobactam antibiotics
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 Solution (AZLI)Also: aztreonam, AZLI, inhaled antibioticAztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer. | Drug | AZLI 75 mg 3 times a day (TID) |
| Tobramycin Inhalation Solution (TIS)Also: tobramycin, TNS, inhaled antibioticTobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling. | Drug | TIS 300 mg 2 times a day (BID) |
Primary outcome
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28
Time frame: Baseline and end of treatment Course 1 (Day 28)
Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.
Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses
Time frame: Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)
Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set.
4 secondary outcomes
Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization
Time frame: Baseline and end of treatment Course 1 (Day 28)
Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization
Time frame: Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)
Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events
Time frame: Day 0 to Day 168 (end of study)
Time to First Respiratory Hospitalization
Time frame: Day 0 to Day 168 (end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22985692Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group. Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.
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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.
Mark Bresnik, MD study director
Gilead Sciences
92 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aztreonam for Inhalation Solution (AZLI) and Tobramycin Inhalation Solution (TIS) in people with Cystic Fibrosis, run by Gilead Sciences at 92 sites in 13 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 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 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, France, Germany, Italy, United Kingdom and 8 more countries. 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. 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 4 Jul 2011). 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?
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (time frame: Baseline and end of treatment Course 1 (Day 28)). The study lists 2 primary outcomes in all. 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 NCT00757237, 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 4 Jul 2011.