AsthmaMIANCT02671773
Characterising the Microbiota in Asthma
An observational study of Asthma, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Previous work has determined that there are significant differences in the communities of bacteria found in the airways of asthmatic patients compared to those found in the airways of healthy people. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Inhaled corticosteroid dose/type
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult asthmatic patients on Step 2 or Step 4 of the British Thoracic Society Asthma stepwise management protocol for asthma whose details are stored on the Nottingham Respiratory Research Patient Database or who attend respiratory clinics at the Nottingham City Hospital
Who may be able to join
- Age 18 or above
- Male or female
- Diagnosis of asthma
- Non-smokers for 10 years and <10 pack year equivalents in total
- BTS Step 2 patients must have been using inhaled steroids at a dose of BDP ≤ 400 mcg/day FP ≤ 200 mcg/day or BUD ≤ 400 mcg/day for at least 1 year
- BTS Step 4 patients must have been using inhaled steroids at a dose of FP ≥ 500 mcg/day or BUD ≥800 mcg/day for at least 1 year as a separate steroid or inhaled steroid/long acting beta agonist combination.
Who cannot join
- Respiratory infection or antibiotics within last month
- Pregnancy or intent to become pregnant during course of study
- Other respiratory diagnosis
- Post bronchodilator FEV1 of < 60%
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Respiratory Research Unit
Nottingham, Nottinghamshire, NG5 1PB
About this study
Previous work has determined that there are significant differences in the communities of bacteria found in the airways of asthmatic patients compared to those found in the airways of healthy people.
It is not yet clear if these bacterial communities are similar in all patients with asthma or if they are different in people with more severe asthma, with different types of asthma or between asthma patients taking different treatment. This is important to know as any differences in the bacteria present between groups may help to explain why people with asthma do not have the same features of disease.
Read more
This research aims to determine if there are any differences in the number and type of bacteria found in the airways of asthmatic patients (1) with different severities of asthma and (2) who use different types of inhaled steroid treatment for asthma.
We will do this by detecting the DNA of bacteria present in phlegm samples from these patients. We will also take measurements of the different components of asthma to see if the bacteria are different in people with different types of disease.
As it is not yet clear if the bacteria detected in phlegm samples from one person may differ on different occasions, we will be taking more than one sample from some patients to see how similar this is over time.
Read the detailed description
The main aim of this project is to determine if microbiota composition is correlated with disease severity (as determined by BTS step). Although initial studies suggest that asthmatics of different severities may have similar microbiota composition, there is no direct evidence to support this assertion. Also, the three main studies in this area so far have all used different sequencing methods, making comparisons difficult.
The relationship between the microbiota composition of different subjects and clinical measures including bronchial hyperreactivity (as measured by methacholine challenge) and pattern of airway inflammation (as measured by sputum differential cell count and exhaled nitric oxide levels) will be investigated further. Comparisons will also be made between samples from asthmatic patients using the inhaled steroid fluticasone and those using budesonide, as there is evidence suggesting that fluticasone leads to an increased risk of pneumonia and non tuberculous mycobacterial disease in certain patient groups. Unpublished data (Astra Zeneca) suggests the excess risk of pneumonia with fluticasone compared to budesonide may be more pronounced after at least 12 months of treatment with inhaled corticosteroid. Microbiota composition of the sputum samples will be evaluated in conjunction with standard microbiological culture of these samples to allow a comparison between these two methods.
In order to assess the reproducibility of the induced sputum method for assessing the lung microbiota, a repeat sputum sample will be taken from a subgroup of 20 patients within 24 hours of the collection of the first sample and compared. A further sample will be taken from this subgroup of patients 2 weeks later to assess the longitudinal stability of the bacterial population.
- Conditions
- Asthma
- Being tested
- Inhaled corticosteroid dose/type
- Keywords
- Microbiota
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled corticosteroid dose/typeDrug
| Study group | Role | What they receive |
|---|---|---|
| BTS Step 2 Asthmatic patients | Group of 20 asthmatic patients on British Thoracic Society (BTS) treatment step 2 - regular low dose inhaled corticosteroids (dose of <400 micrograms/day BDP equivalent) Receives: Drug: Inhaled corticosteroid dose/type | |
| BTS Step 4 Asthmatic patients on treatment with fluticasone | Group of 15 asthmatic patients on British Thoracic Society (BTS) treatment step 4 - high dose inhaled fluticasone (dose of >500 micrograms/day) Receives: Drug: Inhaled corticosteroid dose/type | |
| BTS Step 4 Asthmatic patients on treatment with budesonide | Group of 15 asthmatic patients on British Thoracic Society (BTS) treatment step 4 - high dose inhaled budesonide (dose of >800 micrograms/day) Receives: Drug: Inhaled corticosteroid dose/type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs subject BTS treatment step
Measured: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs subject BTS treatment step
Measured: 1 day
Secondary outcomes (30)
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs FEV1
Measured: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs FEV1
Measured: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs sputum differential cell count (%eosinophils/%neutrophils)
Measured: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs sputum differential cell count (%eosinophils/%neutrophils)
Measured: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs exhaled nitric oxide level (ppb)
Measured: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs exhaled nitric oxide level (ppb)
Measured: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v PC20 (mg/ml)
Measured: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v PC20 (mg/ml)
Measured: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v Leicester Cough Questionnaire (LCQ) score
Measured: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v Leicester Cough Questionnaire (LCQ) score
Measured: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v Asthma Control Questionnaire Score
Measured: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v Asthma Control Questionnaire Score
Measured: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide
Measured: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide
Measured: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%))
Measured: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%))
Measured: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) stability over 24 hour period
Measured: 2 days
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) stability over 24 hour period
Measured: 2 days
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) over 2 week period
Measured: 2 weeks
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) over 2 week period
Measured: 2 weeks
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs subject BTS treatment step
Measured: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs subject BTS treatment step vs FEV1
Measured: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs sputum differential cell count (%eosinophils/%neutrophils)
Measured: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs exhaled nitric oxide level (ppb)
Measured: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs PC20 (mg/ml)
Measured: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs Leicester Cough Questionnaire (LCQ) score
Measured: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs Asthma Control Questionnaire Score
Measured: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide
Measured: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) stability over 24 hour period
Measured: 2 days
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%))
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671773
- Sponsor's protocol ID
- 14016
- Acronym
- MIA
- Status last verified
- Jan 2016
- First submitted
- 25 Sep 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin MJ, Zain NMM, Hearson G, Rivett DW, Koller G, Wooldridge DJ, Rose G, Gharbia SE, Forbes B, Bruce KD, Harrison TW. The airways microbiome of individuals with asthma treated with high and low doses of inhaled corticosteroids. PLoS One. 2020 Dec 30;15(12):e0244681. doi: 10.1371/journal.pone.0244681. eCollection 2020.
PubMed 33378384
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising the Microbiota in Asthma
- ClinicalTrials.gov ID
- NCT02671773
- Acronym / sponsor ID
- MIA / 14016
- Conditions
- Asthma
- Keywords
- Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous work has determined that there are significant differences in the communities of bacteria found in the airways of asthmatic patients compared to those found in the airways of healthy people.
It is not yet clear if these bacterial communities are similar in all patients with asthma or if they are different in people with more severe asthma, with different types of asthma or between asthma patients taking different treatment. This is important to know as any differences in the bacteria present between groups may help to explain why people with asthma do not have the same features of disease.
This research aims to determine if there are any differences in the number and type of bacteria found in the airways of asthmatic patients (1) with different severities of asthma and (2) who use different types of inhaled steroid treatment for asthma.
We will do this by detecting the DNA of bacteria present in phlegm samples from these patients. We will also take measurements of the different components of asthma to see if the bacteria are different in people with different types of disease.
As it is not yet clear if the bacteria detected in phlegm samples from one person may differ on different occasions, we will be taking more than one sample from some patients to see how similar this is over time.
Detailed description
The main aim of this project is to determine if microbiota composition is correlated with disease severity (as determined by BTS step). Although initial studies suggest that asthmatics of different severities may have similar microbiota composition, there is no direct evidence to support this assertion. Also, the three main studies in this area so far have all used different sequencing methods, making comparisons difficult.
The relationship between the microbiota composition of different subjects and clinical measures including bronchial hyperreactivity (as measured by methacholine challenge) and pattern of airway inflammation (as measured by sputum differential cell count and exhaled nitric oxide levels) will be investigated further. Comparisons will also be made between samples from asthmatic patients using the inhaled steroid fluticasone and those using budesonide, as there is evidence suggesting that fluticasone leads to an increased risk of pneumonia and non tuberculous mycobacterial disease in certain patient groups. Unpublished data (Astra Zeneca) suggests the excess risk of pneumonia with fluticasone compared to budesonide may be more pronounced after at least 12 months of treatment with inhaled corticosteroid. Microbiota composition of the sputum samples will be evaluated in conjunction with standard microbiological culture of these samples to allow a comparison between these two methods.
In order to assess the reproducibility of the induced sputum method for assessing the lung microbiota, a repeat sputum sample will be taken from a subgroup of 20 patients within 24 hours of the collection of the first sample and compared. A further sample will be taken from this subgroup of patients 2 weeks later to assess the longitudinal stability of the bacterial population.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BTS Step 2 Asthmatic patients | – | Drug: Inhaled corticosteroid dose/typeGroup of 20 asthmatic patients on British Thoracic Society (BTS) treatment step 2 - regular low dose inhaled corticosteroids (dose of <400 micrograms/day BDP equivalent) |
| BTS Step 4 Asthmatic patients on treatment with fluticasone | – | Drug: Inhaled corticosteroid dose/typeGroup of 15 asthmatic patients on British Thoracic Society (BTS) treatment step 4 - high dose inhaled fluticasone (dose of >500 micrograms/day) |
| BTS Step 4 Asthmatic patients on treatment with budesonide | – | Drug: Inhaled corticosteroid dose/typeGroup of 15 asthmatic patients on British Thoracic Society (BTS) treatment step 4 - high dose inhaled budesonide (dose of >800 micrograms/day) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult asthmatic patients on Step 2 or Step 4 of the British Thoracic Society Asthma stepwise management protocol for asthma whose details are stored on the Nottingham Respiratory Research Patient Database or who attend respiratory clinics at the Nottingham City Hospital
Key inclusion criteria (6 listed)
- Age 18 or above
- Male or female
- Diagnosis of asthma
- Non-smokers for 10 years and <10 pack year equivalents in total
- BTS Step 2 patients must have been using inhaled steroids at a dose of BDP ≤ 400 mcg/day FP ≤ 200 mcg/day or BUD ≤ 400 mcg/day for at least 1 year
Key exclusion criteria (4 listed)
- Respiratory infection or antibiotics within last month
- Pregnancy or intent to become pregnant during course of study
- Other respiratory diagnosis
- Post bronchodilator FEV1 of < 60%
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 |
|---|---|---|
| Inhaled corticosteroid dose/type | Drug | BTS Step 2 Asthmatic patients, BTS Step 4 Asthmatic patients on treatment with budesonide, BTS Step 4 Asthmatic patients on treatment with fluticasone |
Primary outcome
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs subject BTS treatment step
Time frame: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs subject BTS treatment step
Time frame: 1 day
30 secondary outcomes
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs FEV1
Time frame: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs FEV1
Time frame: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs sputum differential cell count (%eosinophils/%neutrophils)
Time frame: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs sputum differential cell count (%eosinophils/%neutrophils)
Time frame: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs exhaled nitric oxide level (ppb)
Time frame: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs exhaled nitric oxide level (ppb)
Time frame: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v PC20 (mg/ml)
Time frame: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v PC20 (mg/ml)
Time frame: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v Leicester Cough Questionnaire (LCQ) score
Time frame: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v Leicester Cough Questionnaire (LCQ) score
Time frame: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v Asthma Control Questionnaire Score
Time frame: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v Asthma Control Questionnaire Score
Time frame: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide
Time frame: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide
Time frame: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%))
Time frame: 1 day
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%))
Time frame: 1 day
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) stability over 24 hour period
Time frame: 2 days
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) stability over 24 hour period
Time frame: 2 days
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) over 2 week period
Time frame: 2 weeks
Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) over 2 week period
Time frame: 2 weeks
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs subject BTS treatment step
Time frame: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs subject BTS treatment step vs FEV1
Time frame: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs sputum differential cell count (%eosinophils/%neutrophils)
Time frame: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs exhaled nitric oxide level (ppb)
Time frame: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs PC20 (mg/ml)
Time frame: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs Leicester Cough Questionnaire (LCQ) score
Time frame: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs Asthma Control Questionnaire Score
Time frame: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide
Time frame: 1 day
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) stability over 24 hour period
Time frame: 2 days
Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%))
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Derived from this study: PubMed 33378384Martin MJ, Zain NMM, Hearson G, Rivett DW, Koller G, Wooldridge DJ, Rose G, Gharbia SE, Forbes B, Bruce KD, Harrison TW. The airways microbiome of individuals with asthma treated with high and low doses of inhaled corticosteroids. PLoS One. 2020 Dec 30;15(12):e0244681. doi: 10.1371/journal.pone.0244681. eCollection 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of Nottingham at 1 site in United Kingdom.
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 6 inclusion and 4 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs subject BTS treatment step (time frame: 1 day). 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 NCT02671773, 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 2 Feb 2016.