Chronic Obstructive Pulmonary DiseasePhase 2NCT01153321

Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing AZD2423 in people with Chronic Obstructive Pulmonary Disease and Lung Disease, run by AstraZeneca at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease, Lung Disease
What is being tested?: AZD2423
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 71 participants
Where: 1 siteGermany
Study dates: Oct 2010to Jul 2011
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
≥ 40 years of age at Visit 1
Clinical diagnosis of COPD (GOLD stage 1)
FEV1 ≥ 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)
FEV1/FVC <70% post-bronchodilator at Visit 1 (GOLD stage 1)

Who cannot join

Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
Any clinically relevant abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability or take part or influence the results of the study
A past history or current indication of renal (kidney) failure
Subjects at risk of active tuberculosis or of disease reactivation
Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Hanover, Hannover

Other trials in Germany

About this study

Official title: A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase IIa Study to Investigate the Effects of 100mg AZD2423 as an Oral Tablet in Subjects With Mild COPD Following Segmental Endobronchial LPS Instillation

The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.

Conditions: Chronic Obstructive Pulmonary Disease, Lung Disease
Being tested: AZD2423, AZD2423 Placebo
Keywords: Respiratory disease, chronic obstructive pulmonary disease
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD2423Drug
100mg Oral dose od
AZD2423 PlaceboDrug
Oral dose od

Study groups in NCT01153321
Study group	Role	What they receive
1	Experimental	Oral treatment Receives: Drug: AZD2423
2	Placebo comparator	Oral treatment Receives: Drug: AZD2423 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute Monocyte Count in BAL Post-LPS Challenge
Monocyte count in BAL post-LPS challenge (Day 11)
Measured: Day 11

Secondary outcomes (53)

Total Neutrophils in Biopsy Sample (Post-LPS Challenge)
Pre-challenge = Day 11. Biopsies taken from left lingula. Cells counted in subepithelium.
Measured: Day 11
Total Macrophages in Biopsy Sample (Post-LPS Challenge)
Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.
Measured: Day 11
CD45+ in Biopsy Sample (Post-LPS Challenge)
Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.
Measured: Day 11
CD3+ in Biopsy Sample (Post-LPS Challenge)
Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.
Measured: Day 11
Biopsy PAS Reaction Grade (Post-LPS Challenge)
Biopsies stained using PAS method. Graded on subjective scale (1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells).
Measured: Day 11
Biopsy Epithelium Grade (Post-LPS Challenge)
Biopsies (from right middle lobe) were assessed for routine histopathology. Epithelial morphology was graded on subjective scale from 1 to 5. 1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells
Measured: Day 11
Eosinophils in BAL (Post-LPS Challenge)
Post-LPS challenge eosinophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.
Measured: Day 11
Lymphocytes in BAL (Post-LPS Challenge)
Post-LPS challenge lymphocyte differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.
Measured: Day 11
Neutrophils in BAL (Post-LPS Challenge)
Post-LPS challenge neutrophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.
Measured: Day 11
Macrophages in BAL (Post-LPS Challenge)
Post-LPS challenge macrophage differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.
Measured: Day 11
TNF α Concentration in BAL (Post-LPS Challenge)
Post-LPS challenge TNF α concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Measured: Day 11
CCL2 Concentration in BAL (Post-LPS Challenge)
Post-LPS challenge CCL2 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Measured: Day 11
IL-1β Concentration in BAL (Post-LPS Challenge)
Post-LPS challenge IL-1β concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Measured: Day 11
IL-6 Concentration in BAL (Post-LPS Challenge)
Post-LPS challenge IL-6 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Measured: Day 11
IL-8 Concentration in BAL (Post-LPS Challenge)
Post-LPS challenge IL 8 concentration in BAL. LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Measured: Day 11
RANTES Concentration in BAL (Post-LPS Challenge)
Post-LPS challenge RANTES concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Measured: Day 11
SP-D Concentration in BAL (Post-LPS Challenge)
Post-LPS challenge SP-D concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Measured: Day 11
SAA Concentration in Blood (Pre-LPS Challenge)
SAA concentration in blood pre-LPS challenge (Day 10).
Measured: Day 10
SAA Concentration in Blood (Post-LPS Challenge)
SAA concentration in blood post-LPS challenge (Day 11)
Measured: Day 11
CCL2 Concentration in Blood (Pre-LPS Challenge)
CCL2 concentration in blood pre-LPS challenge (Day 10)
Measured: Day 10
CCL2 Concentration in Blood (Post-LPS Challenge)
CCL2 concentration in blood post-LPS challenge (Day 11).
Measured: Day 11
IL-1β Concentration in Blood (Pre-LPS Challenge)
IL-1β concentration in blood pre-LPS challenge (Day 10)
Measured: Day 10
IL-1β Concentration in Blood (Post-LPS Challenge)
IL-1β concentration in blood post-LPS challenge (Day 11)
Measured: Day 11
IL-6 Concentration in Blood (Pre-LPS Challenge)
IL-6 concentration in blood pre-LPS challenge (Day 10)
Measured: Day 10
IL-6 Concentration in Blood (Post-LPS Challenge)
IL-6 concentration in blood post-LPS challenge (Day 11)
Measured: Day 11
IL-8 Concentration in Blood (Pre-LPS Challenge)
IL-8 concentration in blood pre-LPS challenge (Day 10)
Measured: Day 10
IL-8 Concentration in Blood (Post-LPS Challenge)
IL-8 concentration in blood post-LPS challenge (Day 11)
Measured: day 11
TNF-α Concentration in Blood (Pre-LPS Challenge)
TNF-α concentration in blood pre-LPS challenge (Day 10)
Measured: Day 10
TNF-α Concentration in Blood (Post-LPS Challenge)
TNF-α concentration in blood post-LPS challenge (Day 11)
Measured: Day 11
SP-D Concentration in Blood (Pre-LPS Challenge)
SP-D concentration in blood pre-LPS challenge (Day 10)
Measured: Day 10
SP-D Concentration in Blood (Post-LPS Challenge)
SP-D concentration in blood post-LPS challenge (Day 11)
Measured: Day 11
CC16 Concentration in Blood (Pre-LPS Challenge)
CC16 concentration in blood pre-LPS challenge (Day 10)
Measured: Day 10
CC16 Concentration in Blood (Post-LPS Challenge)
CC16 concentration in blood post-LPS challenge (Day 11)
Measured: Day 11
Basophils in Blood (Pre-LPS Challenge)
Basophils in blood pre-LPS challenge (Day 10)
Measured: day 10
Basophils in Blood (Post-LPS Challenge)
Basophils in blood post-LPS challenge (Day 11)
Measured: Day 11
Eosinophils in Blood (Pre-LPS Challenge)
Eosinophils in blood pre-LPS challenge (Day 10)
Measured: Day 10
Eosinophils in Blood (Post-LPS Challenge)
Eosinophils in blood post-LPS challenge (Day 11)
Measured: Day 11
Lymphocytes in Blood (Pre-LPS Challenge)
Lymphocytes in blood pre-LPS challenge (Day 10)
Measured: Day 10
Lymphocytes in Blood (Post-LPS Challenge)
Lymphocytes in blood post-LPS challenge (Day 11)
Measured: Day 11
Monocytes in Blood (Pre-LPS Challenge)
Monocytes in blood pre-LPS challenge (Day 10)
Measured: Day 10
Monocytes in Blood (Post-LPS Challenge)
Monocytes in blood post-LPS challenge (Day 11)
Measured: Day 11
Neutrophils in Blood (Pre-LPS Challenge)
Neutrophils in blood pre-LPS challenge (Day 10)
Measured: Day 10
Neutrophils in Blood (Post-LPS Challenge)
Neutrophils in blood post-LPS challenge (Day 11)
Measured: Day 11
Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State
Steady state pharmacokinetic (PK) profile measured on Day 10
Measured: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Time to Cmax (Tmax) of AZD2423 at Steady State
Steady state PK profile measured on Day 10
Measured: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State
Steady state PK profile measured on Day 10
Measured: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State
Steady state PK profile measured on Day 10
Measured: Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose
Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes
Measured: up to 47 days (visit 1 to visit 6)
Number of Participants With Clinically Relevant Changes in Vital Signs
Measured: up to 47 days (visit 1 to visit 6)
Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables
Measured: up to 47 days (visit 1 to visit 6)
Number of Participants With Clinically Relevant Changes in Physical Examination
Measured: up to 47 days (visit 1 to visit 6)
Number of Participants With Treatment-related or Clinically Relevant Changes in Spirometry (Forced Expiratory Volume in 1 Second [FEV1], Forced Vital Capacity [FVC] Pre-bronchodilator)
Measured: up to 47 days (visit 1 to visit 6)
CC16 Concentration in BAL (Post-LPS Challenge)
Post-LPS challenge CC16 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.
Measured: Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Jul 2011

First posted30 Jun 2010 (estimated)
Study startOct 2010
Primary completionJul 2011
Study completionJul 2011

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 Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01153321
Sponsor's protocol ID: D3320C00001
Other IDs: 2010-020141-26
Status last verified: Mar 2015
First submitted: 28 Jun 2010
Last updated: 10 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase IIa Study to Investigate the Effects of 100mg AZD2423 as an Oral Tablet in Subjects With Mild COPD Following Segmental Endobronchial LPS Instillation
ClinicalTrials.gov ID: NCT01153321
Acronym / sponsor ID: D3320C00001
Conditions: Chronic Obstructive Pulmonary Disease, Lung Disease
Keywords: Respiratory disease, chronic obstructive pulmonary disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 30 Jun 2010 (estimated)
Results: Posted 23 Oct 2014

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 the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: AZD2423Oral treatment
2	Placebo comparator	Drug: AZD2423 PlaceboOral treatment

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
≥ 40 years of age at Visit 1
Clinical diagnosis of COPD (GOLD stage 1)
FEV1 ≥ 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)
FEV1/FVC <70% post-bronchodilator at Visit 1 (GOLD stage 1)

Key exclusion criteria (5 listed)

Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
Any clinically relevant abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability or take part or influence the results of the study
A past history or current indication of renal (kidney) failure
Subjects at risk of active tuberculosis or of disease reactivation
Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)

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
AZD2423100mg Oral dose od	Drug	1
AZD2423 PlaceboOral dose od	Drug	2

Primary outcome

Absolute Monocyte Count in BAL Post-LPS Challenge
Time frame: Day 11
Monocyte count in BAL post-LPS challenge (Day 11)

53 secondary outcomes

Total Neutrophils in Biopsy Sample (Post-LPS Challenge)
Time frame: Day 11
Total Macrophages in Biopsy Sample (Post-LPS Challenge)
Time frame: Day 11
CD45+ in Biopsy Sample (Post-LPS Challenge)
Time frame: Day 11
CD3+ in Biopsy Sample (Post-LPS Challenge)
Time frame: Day 11
Biopsy PAS Reaction Grade (Post-LPS Challenge)
Time frame: Day 11
Biopsy Epithelium Grade (Post-LPS Challenge)
Time frame: Day 11
Eosinophils in BAL (Post-LPS Challenge)
Time frame: Day 11
Lymphocytes in BAL (Post-LPS Challenge)
Time frame: Day 11
Neutrophils in BAL (Post-LPS Challenge)
Time frame: Day 11
Macrophages in BAL (Post-LPS Challenge)
Time frame: Day 11
TNF α Concentration in BAL (Post-LPS Challenge)
Time frame: Day 11
CCL2 Concentration in BAL (Post-LPS Challenge)
Time frame: Day 11
IL-1β Concentration in BAL (Post-LPS Challenge)
Time frame: Day 11
IL-6 Concentration in BAL (Post-LPS Challenge)
Time frame: Day 11
IL-8 Concentration in BAL (Post-LPS Challenge)
Time frame: Day 11
RANTES Concentration in BAL (Post-LPS Challenge)
Time frame: Day 11
SP-D Concentration in BAL (Post-LPS Challenge)
Time frame: Day 11
SAA Concentration in Blood (Pre-LPS Challenge)
Time frame: Day 10
SAA Concentration in Blood (Post-LPS Challenge)
Time frame: Day 11
CCL2 Concentration in Blood (Pre-LPS Challenge)
Time frame: Day 10
CCL2 Concentration in Blood (Post-LPS Challenge)
Time frame: Day 11
IL-1β Concentration in Blood (Pre-LPS Challenge)
Time frame: Day 10
IL-1β Concentration in Blood (Post-LPS Challenge)
Time frame: Day 11
IL-6 Concentration in Blood (Pre-LPS Challenge)
Time frame: Day 10
IL-6 Concentration in Blood (Post-LPS Challenge)
Time frame: Day 11
IL-8 Concentration in Blood (Pre-LPS Challenge)
Time frame: Day 10
IL-8 Concentration in Blood (Post-LPS Challenge)
Time frame: day 11
TNF-α Concentration in Blood (Pre-LPS Challenge)
Time frame: Day 10
TNF-α Concentration in Blood (Post-LPS Challenge)
Time frame: Day 11
SP-D Concentration in Blood (Pre-LPS Challenge)
Time frame: Day 10
SP-D Concentration in Blood (Post-LPS Challenge)
Time frame: Day 11
CC16 Concentration in Blood (Pre-LPS Challenge)
Time frame: Day 10
CC16 Concentration in Blood (Post-LPS Challenge)
Time frame: Day 11
Basophils in Blood (Pre-LPS Challenge)
Time frame: day 10
Basophils in Blood (Post-LPS Challenge)
Time frame: Day 11
Eosinophils in Blood (Pre-LPS Challenge)
Time frame: Day 10
Eosinophils in Blood (Post-LPS Challenge)
Time frame: Day 11
Lymphocytes in Blood (Pre-LPS Challenge)
Time frame: Day 10
Lymphocytes in Blood (Post-LPS Challenge)
Time frame: Day 11
Monocytes in Blood (Pre-LPS Challenge)
Time frame: Day 10

Results and safety

Results posted to the registry on 23 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD2423	22	21
Placebo	22	19

Primary outcome: Absolute Monocyte Count in BAL Post-LPS Challenge

Time frame: Day 11. Least squares mean (Standard Error). Unit: x10^4 cells/mL

Measure	AZD2423 n = 20	Placebo n = 19
Value	398 (1.276)	514.4 (1.284)

Population analysed: Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge

53 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD2423 100 mg	0 of 22 (0%)	10 of 22 (45.5%)	Not reported
Placebo	3 of 22 (13.6%)	15 of 22 (68.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
D3320C00001 Clinical Study Report SynopsisLink provided by the sponsor.
D3320C00001 CSR SynopsisLink provided by the sponsor.

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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.

Bengt Larsson study director

AstraZeneca R&D

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2423 in people with Chronic Obstructive Pulmonary Disease and Lung Disease, run by AstraZeneca at 1 site in Germany.

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 5 inclusion and 5 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 Apr 2015. 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 Germany. 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 23 Oct 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?

Absolute Monocyte Count in BAL Post-LPS Challenge (time frame: Day 11). 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 NCT01153321.

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 Apr 2015.