BronchiectasisPhase 2NCT00775138
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
A Phase 2 study testing 280 mg Arikayce™ and 560 mg Arikayce™ in people with Bronchiectasis, run by Insmed Incorporated at 18 sites in 9 countries.
Trial summary
This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- 280 mg Arikayce™ and 560 mg Arikayce™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 18 sitesin 9 countries
- Study dates
- 24 Jun 2008to 11 May 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female study subjects≥ 18 years of age
- Confirmed diagnosis of multi-focal bronchiectasis in two or more lung segments by HRCT of the chest
- History of chronic infection with P. aeruginosa
- Confirmation of infection with P. aeruginosa at screening
- SaO2 ≥ 90% at Screening while breathing room air
- Ability to comply with study medication use, study visits, and study procedures as judged by the investigator
- Ability to produce at least 0.5 grams sputum or be willing to undergo an induction to produce sputum for clinical evaluation
Who cannot join
- Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted at Screening
- Patients with hemoptysis of ≥60 mL within 4 weeks prior to screening
- Bronchiectasis due to cystic fibrosis (CF), bronchopulmonary Aspergillus, aspiration of foreign body, or secondary to lung compression from tumors
- History of non-tuberculous mycobacterial and/or Aspergillus infection requiring treatment or treated within 2 years prior to screening
- Pulmonary tuberculosis requiring treatment or treated within two years prior to screening
- History of Lung transplantation
Show all 10Show fewer
- Use of any inhalation or systemic antibiotics (IV antibiotics, or oral antibiotics) within 4 weeks prior to Study Day 1
- Evidence of biliary cirrhosis with portal hypertension
- Smoking tobacco or any substance within 6 months prior to screening, and throughout the study
- History of alcohol, medication, or illicit drug abuse within the 1 year prior to screening
Trial locations and contacts
18 sites in 9 countries.
18 sites in 9 countries
India6 sites
Study site
Bangalore
Study site
Hyderabad
Study site
Manipal
Study site
Mumbai
Study site
Nagpur
Study site
New Delhi
United States2 sites
Study site
Philadelphia, Pennsylvania
Study site
Washington D.C., District of Columbia
About this study
Official title: A Placebo Controlled, Randomized, Parallel Cohort, Safety And Tolerability Study Of 2 Dose Levels Of Liposomal Amikacin For Inhalation (Arikayce™) In Patients With Bronchiectasis Complicated By Chronic Infection Due To Pseudomonas Aeruginosa.
This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.
Read the detailed description
Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients.
This is a multi-national Phase 2 study of safety and tolerability of 28 days of daily dosing with two dose levels (280 mg and 560 mg) of Arikayce™ versus placebo in subjects with bronchiectasis and chronic Pseudomonas infection. Study subjects will be randomized to receive either study drug or placebo by inhalation via a PARI eFlow® nebulizer. Each subject will complete 28 days of daily dosing. All study subjects will be followed for microbiologic activity for 14 days after completion of treatment and for safety for 28 days post completion of study treatment.
The total study duration will be 56 days, with the screening visit occurring within the preceding 14 days prior to study day 1. At Day 1 (baseline), subjects will be evaluated at pre-dose and during the first 4-5 hours post-dose. Subjects will return at Week 2 (day 14) after start of treatment and at the end of Week 4 (Day 28) treatment period to determine safety and efficacy of Arikayce™. Subjects will be followed up on study Days 42 and 56 (about 2 and 4 weeks after end of treatment) for safety determination. After completion of this study, subjects will be followed up for an additional 6 months via phone contacts and records review, if hospitalized or treated for pulmonary exacerbation (under the extension protocol).
Clinical laboratory parameters, audiology testing, clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and tolerability of Arikayce™ compared to placebo. Serum, urine and sputum specimens will be collected at periodic intervals to assess pharmacokinetics (PK) in subjects who consent for the PK portion of the study. Additionally, sputum samples will be collected to determine changes in bacterial density. Total Pulmonary Symptom Severity Score (PSSS) will be assessed, and respiratory quality of life will be evaluated by using the St. George's Respiratory Questionnaire (SGRQ). Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and the other studies evaluating amikacin liposome inhalation suspension.
- Conditions
- Bronchiectasis
- Being tested
- 280 mg Arikayce™, Matching Placebo for Cohort 1, 560 mg Arikayce™, Matching Placebo for Cohort 2
- Keywords
- Bronchiectasis, Respiratory Infections, Amikacin, Respiratory Tract Diseases, Respiratory Tract Infections, Lung Diseases, Pseudomonas aeruginosa, Amikacin liposome inhalation suspension (ALIS)
- Medical subject headings
- Bronchiectasis, Respiratory Tract Infections, Respiratory Tract Diseases, Lung Diseases, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
280 mg Arikayce™Drug
Also called liposomal amikacin for inhalation
Study subjects will receive Arikace™ 280 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
Matching Placebo for Cohort 1Drug
Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
560 mg Arikayce™Drug
Also called liposomal amikacin for inhalation
Study subjects will receive Arikace™ 560 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
Matching Placebo for Cohort 2Drug
Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - 280 mg Arikayce™ | Experimental | Subjects in this arm of the cohort 1 will receive 280 mg of Arikayce™ Receives: Drug: 280 mg Arikayce™ |
| Cohort 1 - Placebo | Placebo comparator | Subjects in this arm of the cohort 1 will receive matching placebo. Receives: Drug: Matching Placebo for Cohort 1 |
| Cohort 2 - 560 mg Arikayce™ | Experimental | Subjects in this arm of the cohort 2 will receive 560 mg of Arikayce™ Receives: Drug: 560 mg Arikayce™ |
| Cohort 2 - Placebo | Placebo comparator | Subjects in this arm of the cohort 2 will receive matching placebo Receives: Drug: Matching Placebo for Cohort 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Number of Subjects reporting TEAE in the Arikayce™ groups and the placebo groups during the study. The table shows the events incidents, not the number of participants.
Measured: Day 1 through 56.
Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Number of subjects reporting Incidence of clinically significant abnormalities in clinical values (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 3) in Arikayce™ and placebo groups.
Measured: Day 1 through 56.
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Changes in PFT from pre-dose during the study were measured on Days 1, 14, and 28. Acute tolerability of the study treatment was assessed by examining the relative (rel.) changes in FEV1 from pre-dose assessments to 0-1 hour post-dose and 2-4 hours post-dose for each time point at which post-dose spirometry was conducted.
Measured: Pre-dose, 0-1 hour post-dose and 2-4 hours post-dose on day 1, 0-1 hour post-dose and 2-4 hours post-dose on day 14, and 0-1 hour post-dose and 2-4 hours post-dose on day 28
Treatment-emergent PFT Abnormalities up to the End of Study
Number of Subjects with Decrease of >= 15% in FEV1 (L) from Pre- to Post-dose by Study Day
Measured: Day 1, Day 14 and Day 28
Number of Subjects With an Adverse Event Leading to Permanent Discontinuation of Study Medication
Measured: Screening to Day 56
Serious Adverse Events up to 28 Days After Study Medication Discontinuation
Number of subjects with a SAE in the Arikace™ groups and the placebo group up to 28 days after study medication discontinuation. See SAE table in the safety section for details.
Measured: Screening to Day 56
Secondary outcomes (4)
Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.
The change in Pseudomonas aeruginosa density from from baseline to Day 14, 28, and 42 were evaluated.Treatment differences with respect to the changes from baseline to each measured study day, defined as the log10 of the sum of all morphotypes (colony-forming units [CFU]) per gram of sputum in (log10CFU/gram [g]), was estimated for each treatment group; standard deviations accompanied the treatment differences.
Measured: Baseline to Day 14, Day 28 and Day 42.
Total Pulmonary Symptom Severity Score (PSSS)
Changes in the severity and intensity (frequency x severity) of individual symptoms and change in composite PSSS from baseline to Days 14, 28, 42 and 56.
The Pulmonary Symptom Severity Score (PSSS) was assessed on patient's responses to the Patients Symptoms Questionnaire, which employs symptom frequency and severity scales described for the validated Memorial Symptoms Assessment Scale. Symptom severity was scored on a scale of 0 (not applicable or symptom not present) to 4 (very severe) for each of the 5 symptoms (cough, shortness of breath, sputum production [frequency and severity], fatigue, and wheezing), and a composite score (range, 0 to 20 [low score represents better outcome]) was obtained as the sum of the severity scores for each symptom.
Measured: Baseline to Day 14, Day 28, Day 42 and Day 56.
To Evaluate Change in St. George's Respiratory Questionnaire Measurements
A composite total score is derived as the sum of domain scores for symptoms, activity, and impact, with 0 as the best possible score and 100 as the worst possible score. A reduction in score of 4 points is generally recognized as a clinically meaningful improvement in quality of life. This analysis compared the changes from Day 1 (prior to first dosing) to Days 14, 28, 42, and 56.
Measured: Day 1 to Day 14, Day 28, Day 42 and Day 56.
To Evaluate the Use of Systemic Antipseudomonal Rescue Therapy
Measured: Screening to Day 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study start24 Jun 2008
- Primary completion11 May 2009
- Study completion11 May 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.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gina Eagle, MD, Study director, Insmed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775138
- Sponsor's protocol ID
- TR02-107
- Status last verified
- Jun 2019
- First submitted
- 15 Oct 2008
- Last updated
- 10 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Randomized, Parallel Cohort, Safety And Tolerability Study Of 2 Dose Levels Of Liposomal Amikacin For Inhalation (Arikayce™) In Patients With Bronchiectasis Complicated By Chronic Infection Due To Pseudomonas Aeruginosa.
- ClinicalTrials.gov ID
- NCT00775138
- Acronym / sponsor ID
- TR02-107
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Respiratory Infections, Amikacin, Respiratory Tract Diseases, Respiratory Tract Infections, Lung Diseases, Pseudomonas aeruginosa, Amikacin liposome inhalation suspension (ALIS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2008 (actual)
- Primary completion
- 11 May 2009 (actual)
- Study completion
- 11 May 2009 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.
Detailed description
Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients.
This is a multi-national Phase 2 study of safety and tolerability of 28 days of daily dosing with two dose levels (280 mg and 560 mg) of Arikayce™ versus placebo in subjects with bronchiectasis and chronic Pseudomonas infection. Study subjects will be randomized to receive either study drug or placebo by inhalation via a PARI eFlow® nebulizer. Each subject will complete 28 days of daily dosing. All study subjects will be followed for microbiologic activity for 14 days after completion of treatment and for safety for 28 days post completion of study treatment.
The total study duration will be 56 days, with the screening visit occurring within the preceding 14 days prior to study day 1. At Day 1 (baseline), subjects will be evaluated at pre-dose and during the first 4-5 hours post-dose. Subjects will return at Week 2 (day 14) after start of treatment and at the end of Week 4 (Day 28) treatment period to determine safety and efficacy of Arikayce™. Subjects will be followed up on study Days 42 and 56 (about 2 and 4 weeks after end of treatment) for safety determination. After completion of this study, subjects will be followed up for an additional 6 months via phone contacts and records review, if hospitalized or treated for pulmonary exacerbation (under the extension protocol).
Clinical laboratory parameters, audiology testing, clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and tolerability of Arikayce™ compared to placebo. Serum, urine and sputum specimens will be collected at periodic intervals to assess pharmacokinetics (PK) in subjects who consent for the PK portion of the study. Additionally, sputum samples will be collected to determine changes in bacterial density. Total Pulmonary Symptom Severity Score (PSSS) will be assessed, and respiratory quality of life will be evaluated by using the St. George's Respiratory Questionnaire (SGRQ). Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and the other studies evaluating amikacin liposome inhalation suspension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - 280 mg Arikayce™ | Experimental | Drug: 280 mg Arikayce™Subjects in this arm of the cohort 1 will receive 280 mg of Arikayce™ |
| Cohort 1 - Placebo | Placebo comparator | Drug: Matching Placebo for Cohort 1Subjects in this arm of the cohort 1 will receive matching placebo. |
| Cohort 2 - 560 mg Arikayce™ | Experimental | Drug: 560 mg Arikayce™Subjects in this arm of the cohort 2 will receive 560 mg of Arikayce™ |
| Cohort 2 - Placebo | Placebo comparator | Drug: Matching Placebo for Cohort 2Subjects in this arm of the cohort 2 will receive matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female study subjects≥ 18 years of age
- Confirmed diagnosis of multi-focal bronchiectasis in two or more lung segments by HRCT of the chest
- History of chronic infection with P. aeruginosa
- Confirmation of infection with P. aeruginosa at screening
- SaO2 ≥ 90% at Screening while breathing room air
Key exclusion criteria (10 listed)
- Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted at Screening
- Patients with hemoptysis of ≥60 mL within 4 weeks prior to screening
- Bronchiectasis due to cystic fibrosis (CF), bronchopulmonary Aspergillus, aspiration of foreign body, or secondary to lung compression from tumors
- History of non-tuberculous mycobacterial and/or Aspergillus infection requiring treatment or treated within 2 years prior to screening
- Pulmonary tuberculosis requiring treatment or treated within two years prior to screening
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 |
|---|---|---|
| 280 mg Arikayce™Also: liposomal amikacin for inhalationStudy subjects will receive Arikace™ 280 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer. | Drug | Cohort 1 - 280 mg Arikayce™ |
| Matching Placebo for Cohort 1Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer. | Drug | Cohort 1 - Placebo |
| 560 mg Arikayce™Also: liposomal amikacin for inhalationStudy subjects will receive Arikace™ 560 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer. | Drug | Cohort 2 - 560 mg Arikayce™ |
| Matching Placebo for Cohort 2Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer. | Drug | Cohort 2 - Placebo |
Primary outcome
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Time frame: Day 1 through 56.
Number of Subjects reporting TEAE in the Arikayce™ groups and the placebo groups during the study. The table shows the events incidents, not the number of participants.
Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Time frame: Day 1 through 56.
Number of subjects reporting Incidence of clinically significant abnormalities in clinical values (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 3) in Arikayce™ and placebo groups.
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Time frame: Pre-dose, 0-1 hour post-dose and 2-4 hours post-dose on day 1, 0-1 hour post-dose and 2-4 hours post-dose on day 14, and 0-1 hour post-dose and 2-4 hours post-dose on day 28
Changes in PFT from pre-dose during the study were measured on Days 1, 14, and 28. Acute tolerability of the study treatment was assessed by examining the relative (rel.) changes in FEV1 from pre-dose assessments to 0-1 hour post-dose and 2-4 hours post-dose for each time point at which post-dose spirometry was conducted.
Treatment-emergent PFT Abnormalities up to the End of Study
Time frame: Day 1, Day 14 and Day 28
Number of Subjects with Decrease of >= 15% in FEV1 (L) from Pre- to Post-dose by Study Day
Number of Subjects With an Adverse Event Leading to Permanent Discontinuation of Study Medication
Time frame: Screening to Day 56
Serious Adverse Events up to 28 Days After Study Medication Discontinuation
Time frame: Screening to Day 56
Number of subjects with a SAE in the Arikace™ groups and the placebo group up to 28 days after study medication discontinuation. See SAE table in the safety section for details.
4 secondary outcomes
Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.
Time frame: Baseline to Day 14, Day 28 and Day 42.
Total Pulmonary Symptom Severity Score (PSSS)
Time frame: Baseline to Day 14, Day 28, Day 42 and Day 56.
To Evaluate Change in St. George's Respiratory Questionnaire Measurements
Time frame: Day 1 to Day 14, Day 28, Day 42 and Day 56.
To Evaluate the Use of Systemic Antipseudomonal Rescue Therapy
Time frame: Screening to Day 56.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Bronchiectasis
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.
Gina Eagle, MD study director
Insmed Incorporated
18 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 280 mg Arikayce™ and 560 mg Arikayce™ in people with Bronchiectasis, run by Insmed Incorporated at 18 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 7 inclusion and 10 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in India, Serbia, United States, United Kingdom, Bulgaria 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. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2019). 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?
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment (time frame: Day 1 through 56.). The study lists 6 primary outcomes in all. 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 10 Jul 2019.