Cystic FibrosisPhase 2ALPINENCT01375049
Aztreonam Lysine for Pseudomonas Infection Eradication Study
A Phase 2 study testing Aztreonam for Inhalation Solution (AZLI) in people with Cystic Fibrosis, run by Gilead Sciences at 58 sites in 9 countries.
Trial summary
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Aztreonam for Inhalation Solution (AZLI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 58 sitesin 9 countries
- Study dates
- Aug 2011to May 2013
- Phase
- Phase 2
- 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females age 3 months to less than 18 years
- Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria:
- Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
- Abnormal nasal transepithelial potential difference test OR
- Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene AND
- One or more clinical features consistent with CF
Show all 12Show fewer
- Documented new onset of positive lower respiratory tract culture (e.g., throat swab, sputum, or BAL) for PA within 30 days of study entry (prior to screening visit) defined as either first lifetime documented PA-positive culture OR PA recovered after at least a 2 year history of PA-negative respiratory cultures (at least 2 cultures per year)
- Forced expiratory volume in 1 second (FEV1) ≥ 80% predicted at screening visit (subjects ≥ 6 years of age)
- Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would have required administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.
- All sexually active females who were of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study. Females utilizing hormonal contraceptives as a birth control method must have used the same method for at least 3 months prior to study drug dosing.
- Males must agree to use barrier contraception (condom with spermicide) during heterosexual intercourse from screening through to study completion and for 90 days from the last dose of study investigational medicinal product
- Participants and/or parent/guardian must be able to give written informed consent prior to any study related procedure
Who cannot join
- Use of IV or inhaled antipseudomonal antibiotics within 2 years of study entry (screening visit)
- Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit)
- History of sputum or throat swab culture yielding Burkholderia spp. within 2 years prior to screening visit
- History of local or systemic hypersensitivity to monobactam antibiotics
- History of intolerance to inhaled short acting beta 2 agonists
- History of lung transplantation
Show all 20Show fewer
- History of AZLI (or Cayston®) administration
- Administration of any investigational drug or device within 28 days prior to screening visit or within 6 half-lives of the investigational drug (whichever is longer)
- Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone per day or 20 mg prednisone every other day
- Current requirement for daily continuous oxygen supplementation or requirement of more than 2 L/minute at night
- Hospitalization for pulmonary-related illness within 28 days prior to screening visit
- Changes in or initiation of chronic azithromycin treatment within 28 days prior to screening visit
- Changes in antimicrobial, bronchodilator (BD), corticosteroid, dornase alfa, or hypertonic saline medications within 7 days prior to screening visit; for participants on a stable regimen of hypertonic saline (28 days on/28 days off), beginning or ending a cycle of hypertonic saline is allowed
- Changes in physiotherapy technique or schedule within 7 days prior to screening visit
- Abnormal renal or hepatic function results at most recent test within the previous 12 months, defined as:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (ULN), or
- Serum creatinine > 2 times ULN for age
- Pregnant or lactating females; a negative urine pregnancy test is required for all females of childbearing potential (unless surgically sterile), and confirmatory serum pregnancy test in the event of an initial positive urine test result
- Any serious or active medical or psychiatric illness (including drug or alcohol abuse), which in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol
- Presence of a condition or abnormality that would compromise the patient's safety or the quality of study data, in the opinion of the investigator
Trial locations and contacts
58 sites in 9 countries.
58 sites in 9 countries
United States23 sites
Akron Children's Hospital
Akron, Ohio, 44308
University of Michigan
Ann Arbor, Michigan, 48109
Children's Hospital Boston
Boston, Massachusetts, 02115
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Cohen Children's Medical Center of NY
Great Neck, New York, 11021
PennState Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Nemours Children's Clinic- Jacksonville
Jacksonville, Florida, 32207
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Nemours Childrens Clinic Orlando
Orlando, Florida, 32801
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
University of Utah
Salt Lake City, Utah, 84108
Saint Louis University
St Louis, Missouri, 63104
SUNY Upstate Medical University
Syracuse, New York, 13210
Toledo Children's Hospital CF Research Center
Toledo, Ohio, 43606
France7 sites
CHU de Boredaux Hôpital des Enfants - Pellegrin CEDRE
Bordeaux, 33076
CRCM mixte / CHU ESTAING
Clermont-Ferrand, 63003
CHI de Créteil Departement pediatrie
Créteil, 94000
Centre hospitalier Robert Bissons CRCM - service pédiatrie
Lisieux, 14100
Service pédiatrie II Hôpital Necker Enfants Malades
Paris, 75743
Hopital Robert Debre
Paris
Centre de Ressources et de Compétences sur la Mucoviscidose ( CRCM), Roscoff, France
Roscoff, 29684
Germany7 sites
Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunolgie Prof. Wahn
Berlin, 13353
Klinik fur Kinder- und Jugendmedizinim St Josef-Hopsital
Bochum
Universitätsklinikum Essen, Zentrum für Kinderheilkunde - Abteilung Allg. Kinderheilkunde/Neuropaediatrie
Erlangen, 91054
Universitaetsklinikum Bonn-Zentrum fuer Kinderheikunde
Essen
Christiane Herzog CF-Center, Goethe University Hospital
Frankfurt, 60590
Universitätsklinikum Gießen und Marburg GmbH
Giessen, 35392
University Children's Hospital
Tübingen, 72076
Italy5 sites
Azienda Ospedaliero-Universitaria di Catania, Dipartimento di Pediatria, UO Broncopneumologia Pediatrica
Catania, 95123
Cystic Fibrosis Centre Paediatric Department, A. Meyer Children Hospital Florence
Florence, 50139
Universita' Federico II di Napoli
Naples, 80131
Fondazione IRCCS, Ospedale Pediatrico, Bambino Gesu' di Roma
Rome, 00165
Centro Fibrosi Cistica di Verona, Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126
Spain5 sites
Hospital Vall D' Hebron Pediatric Pneunmonology and Cystic Fibrosis Clinic
Barcelona, 08035
Hospital infantil Universitario Niño Jesus, Servicio de Neumología Pediatrica
Madrid, 28009
Hospital Ramon y Cajal
Madrid, 28049
Hospital Infantil La Paz
Madrid
Hospital Materno-Infantil Carlos Haya, Servicio de Neumología Pediatrica
Málaga, 29011
Belgium4 sites
Hôpital Universitaire des Enfants Reine Fabiola Brussels
Brussels, 1020
Paediatrics, University Hospital Brussels (UZB)
Brussels, 1090
Pediatric Respiratory Department, Ghent University Hospital
Ghent, 9000
Pediatric Pulmonology, Dept Pediatrics University Hospital Gasthuisberg
Leuven, 3000
Poland4 sites
ISPL Centrum Medyczne
Bialystok, 15-003
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem, Poradnia Leczenia Mukowiscydozy
Gdansk, 80-308
Instytut Gruźlicy i Chorób Płuc, Klinki Pneumologii i Mukowiscydozy
Rabka-Zdrój, 34-700
Instytut Matki i Dziecka Klinika Pediatrii
Warsaw, 01-211
Netherlands2 sites
Division of Respiratory Medicine and Allergology, Department of Pediatrics, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands
Rotterdam, 3015 GJ
Longziekten Universitair Medisch (PEDIATRIC), Ultrecht
Utrecht, 3584 EA
Austria1 site
Medizinische Universität Innsbruck Abt. für Kinder- und Jugendheilkunde, Pädiatrie III (Zystische Fibrose)
Innsbruck, 6020
About this study
Official title: Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA)
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA.
The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).
- Conditions
- Cystic Fibrosis
- Being tested
- Aztreonam for Inhalation Solution (AZLI)
- Keywords
- Cystic fibrosis, CF, PA, Pseudomonas aeruginosa, AZLI, aztreonam
- 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 Cayston®
AZLI 75 mg administered 3 times daily via the investigational eFlow® nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Aztreonam for Inhalation Solution (AZLI) | Experimental | Participants will receive one 28-day course of AZLI, then will be followed for a 24-week period (through Day 196). Receives: Drug: Aztreonam for Inhalation Solution (AZLI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)
The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set.
Measured: Day 28 to Day 196
Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)
The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Sensitivity Analysis Set.
Measured: Day 28 to Day 196
Secondary outcomes (8)
Change From Baseline in FEV1% Predicted
Spirometry assessments were performed only in participants ≥ 6 years of age. Forced expiratory volume in 1 second (FEV1) % predicted was defined as FEV1 of the participant divided by the average FEV1 in the population for any person of similar age, sex and body composition.
Measured: Baseline to Days 28, 56, 112, and 196
Change From Baseline in CFQ-R RSS Score
Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) only in participants ≥ 6 years of age. The range of scores (units) is 0 to 100 with higher scores indicating fewer symptoms.
Measured: Baseline to Days 28, 56, 112, and 196
Percentage of Participants With PA-negative Cultures
The percentage of participants with a PA-negative culture was summarized at each visit.
Measured: Days 28, 56, 112, and 196
Use of Additional (Non-study) Antipseudomonal Antibiotics
The percentage of participants who used additional (non-study) antipseudomonal antibiotics (an indication of PA exacerbation) while on treatment and posttreatment was summarized.
Measured: Baseline to Day 196
Change From Baseline in Weight
Measured: Baseline to Days 28, 56, 112, and 196
Change From Baseline in Height
Measured: Baseline to Days 28, 56, 112, and 196
Change From Baseline in Body Mass Index (BMI)
Measured: Baseline to Days 28, 56, 112, and 196
Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam
The plasma concentration of aztreonam for participants < 6 years of age was obtained 1 hour after the first dose of AZLI on Day 1 and immediately prior to the last dose of AZLI on Day 28.
Measured: Day 1 (1 hour postdose) and Day 28 (immediately prior to dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Bresnik, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375049
- Sponsor's protocol ID
- GS-US-205-0162
- Acronym
- ALPINE
- Status last verified
- Jul 2014
- First submitted
- 15 Jun 2011
- Last updated
- 17 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tiddens HA, De Boeck K, Clancy JP, Fayon M, H G M A, Bresnik M, Derchak A, Lewis SA, Oermann CM; ALPINE study investigators. Open label study of inhaled aztreonam for Pseudomonas eradication in children with cystic fibrosis: The ALPINE study. J Cyst Fibros. 2015 Jan;14(1):111-9. doi: 10.1016/j.jcf.2014.06.003. Epub 2014 Aug 1.
PubMed 25091537
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA)
- ClinicalTrials.gov ID
- NCT01375049
- Acronym / sponsor ID
- ALPINE / GS-US-205-0162
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, CF, PA, Pseudomonas aeruginosa, AZLI, aztreonam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Posted 1 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA.
The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aztreonam for Inhalation Solution (AZLI) | Experimental | Drug: Aztreonam for Inhalation Solution (AZLI)Participants will receive one 28-day course of AZLI, then will be followed for a 24-week period (through Day 196). |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Males or females age 3 months to less than 18 years
- Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria:
- Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
- Abnormal nasal transepithelial potential difference test OR
- Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene AND
Key exclusion criteria (20 listed)
- Use of IV or inhaled antipseudomonal antibiotics within 2 years of study entry (screening visit)
- Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit)
- History of sputum or throat swab culture yielding Burkholderia spp. within 2 years prior to screening visit
- History of local or systemic hypersensitivity to monobactam antibiotics
- History of intolerance to inhaled short acting beta 2 agonists
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: Cayston®AZLI 75 mg administered 3 times daily via the investigational eFlow® nebulizer | Drug | Aztreonam for Inhalation Solution (AZLI) |
Primary outcome
Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)
Time frame: Day 28 to Day 196
The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set.
Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)
Time frame: Day 28 to Day 196
The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Sensitivity Analysis Set.
8 secondary outcomes
Change From Baseline in FEV1% Predicted
Time frame: Baseline to Days 28, 56, 112, and 196
Change From Baseline in CFQ-R RSS Score
Time frame: Baseline to Days 28, 56, 112, and 196
Percentage of Participants With PA-negative Cultures
Time frame: Days 28, 56, 112, and 196
Use of Additional (Non-study) Antipseudomonal Antibiotics
Time frame: Baseline to Day 196
Change From Baseline in Weight
Time frame: Baseline to Days 28, 56, 112, and 196
Change From Baseline in Height
Time frame: Baseline to Days 28, 56, 112, and 196
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline to Days 28, 56, 112, and 196
Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam
Time frame: Day 1 (1 hour postdose) and Day 28 (immediately prior to dosing)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25091537Tiddens HA, De Boeck K, Clancy JP, Fayon M, H G M A, Bresnik M, Derchak A, Lewis SA, Oermann CM; ALPINE study investigators. Open label study of inhaled aztreonam for Pseudomonas eradication in children with cystic fibrosis: The ALPINE study. J Cyst Fibros. 2015 Jan;14(1):111-9. doi: 10.1016/j.jcf.2014.06.003. Epub 2014 Aug 1.
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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
58 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aztreonam for Inhalation Solution (AZLI) in people with Cystic Fibrosis, run by Gilead Sciences at 58 sites in 9 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 12 inclusion and 20 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 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, France, Germany, Italy, Spain and 4 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 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?
Yes. Results are posted in the registry (first posted 1 Jul 2014). 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?
Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set) (time frame: Day 28 to Day 196). 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 NCT01375049, 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 17 Jul 2014.