Graft vs Host DiseaseNCT01327625

Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans

A study testing azithromycin + N-acetylcystein + inhaled corticosteroid in people with Graft vs Host Disease and Bronchiolitis Obliterans, run by Asan Medical Center at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

[Study Objectives] To evaluate the efficacy of azithromycin, N-acetylcystein, and inhaled corticosteroid combination therapy in patients with bronchiolitis obliterans as a complication of allogeneic hematopoietic cell transplantation in terms of response rate at 6 months after treatment initiation based on the… Read more about this study

Who is it for?: Ages 15 to 75 years
Conditions the study is for: Graft vs Host Disease, Bronchiolitis Obliterans
What is being tested?: azithromycin + N-acetylcystein + inhaled corticosteroid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteSouth Korea
Study dates: Mar 2011to Jun 2013
Phase: Interventional
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 15 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients who previously received allogeneic hematopoietic cell transplantation due to hematologic malignancy, bone marrow failure syndrome, and other compatible disease.
Patients who are diagnosed as bronchiolitis obliterans (BO) according to the NIH diagnostic guideline which is suggested as below.
Patients should be 15 years of age or older, but younger than 75 years.
Patients should have estimated life expectancy of more than 3 months.
Patients must have adequate hepatic function (bilirubin less than 3.0 ㎎/㎗, AST and ALT less than three times the upper normal limit).
Patients must have adequate renal function (creatinine less than 2.0 ㎎/㎗).

Who cannot join

Presence of significant active infection
Presence of uncontrolled bleeding
Any coexisting major illness or organ failure
Patients with a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Asan Medical Center
Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell Transpantation

[Study Objectives]

To evaluate the efficacy of azithromycin, N-acetylcystein, and inhaled corticosteroid combination therapy in patients with bronchiolitis obliterans as a complication of allogeneic hematopoietic cell transplantation in terms of response rate at 6 months after treatment initiation based on the improvement of FEV1.

Read the detailed description

Bronchiolitis obliterans (BO) is a graft-versus-host disease of respiratory organs.
Prognosis of BO is very poor, and the overall outcome of patients who are involved in BO is very dismal.
The mechanism of BO has been known to be associated with immune / non-immune response.
Corticosteroid and immunosuppressants are recommended as a best current treatment options for BO, which have been not satisfactory.
Many treatment options have been tried to improve the outcome of BO.
Azithromycin, as an immune modulating agent, has been tried for the treatment of BO, and has been reported to show hopeful results.
N-acetylcystein, as an antioxidative agent, has been tried for BO.
Inhaled corticosteroid may help to improve airway inflammation and decrease the amount of systemic corticosteroid.
These 3 drugs are widely used for other respiratory disease, have been proven to be safe, and have shown some efficacy for BO in various depth of evidence.
In these rationale, we'd like to try the 3-drug combination for BO, to assess the efficacy and safety of these drug combination.

Conditions: Graft vs Host Disease, Bronchiolitis Obliterans
Being tested: azithromycin + N-acetylcystein + inhaled corticosteroid
Keywords: Allogeneic hematopoietic cell transplantation, Graft versus host disease, Bronchiolitis obliterans, Azithromycin, N-acetylcystein, Fluticasone, Inhaled steroid
Medical subject headings: Graft vs Host Disease, Bronchiolitis Obliterans

What participants receive

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

azithromycin + N-acetylcystein + inhaled corticosteroidDrug
Also called Zithromax
- Azithromycin 500mg qd x 1 week --> 250mg qod x 6 months
- N-acetylcystein 200mg tid x 6 months
- Fluticasone 250mcg puff x2/day x 6 months

Study groups in NCT01327625
Study group	Role	What they receive
Azithromycin	Experimental	Patient who are diagnosed as bronchiolitis obliterans according to the WHO criteria Receives: Drug: azithromycin + N-acetylcystein + inhaled corticosteroid

What is being measured

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

Response rate based on the improvement of FEV1
Response rate at 6 months after treatment initiation based on the improvement of FEV1
Measured: 6 months

Secondary outcomes (7)

Clinical benefit rate based on the degree of change in FEV1
Clinical benefit rate at 6 months after treatment initiation based on the degree of change in FEV1
Measured: 6 months
change in FEV1 compared with pretreatment level
Change in FEV1 at 6 months after treatment initiation compared with pretreatment level
Measured: 6 months after treatment initiation
Reduction rate in immunosuppressive agent / systemic corticosteroid
Reduction rate in immunosuppressive agent / systemic corticosteroid at 6 months after treatment initiation
Measured: 6 months after treatment initiation
Discontinuation rate in immunosuppressive agent / systemic corticosteroid
Discontinuation rate in immunosuppressive agent / systemic corticosteroid at 6 months after treatment initiation
Measured: 6 months after treatment initiation
Change in dose-intensity of immunosuppressive agent / systemic corticosteroid compared with pretreatment dose-intensity
Change in dose-intensity of immunosuppressive agent / systemic corticosteroid at 6 month after treatment initiation compared with pretreatment dose-intensity
Measured: 6 months after treatment initiation
event-free survival
Measured: 1 year
overall survival
Measured: 1year

Timeline

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

Mar 2011Jun 2013

First posted1 Apr 2011 (estimated)
Study startMar 2011
Primary completionJun 2013
Study completionJun 2013

Why it stopped: Preliminary reports of this study was too bad.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
More trials run by Asan Medical CenterThe 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01327625
Sponsor's protocol ID: AMC-ALLO-041
Status last verified: Jul 2014
First submitted: 31 Mar 2011
Last updated: 9 Jul 2014
Results posted: No
Data monitoring committee: No

Publications

Patriarca F, Poletti V, Costabel U, Battista ML, Sperotto A, Medeot M, Toffoletti E, Fanin R. Clinical presentation, outcome and risk factors of late-onset non-infectious pulmonary complications after allogeneic stem cell transplantation. Curr Stem Cell Res Ther. 2009 May;4(2):161-7. doi: 10.2174/157488809788167436.
PubMed 19442201
Afessa B, Peters SG. Major complications following hematopoietic stem cell transplantation. Semin Respir Crit Care Med. 2006 Jun;27(3):297-309. doi: 10.1055/s-2006-945530.
PubMed 16791762
Nishio N, Yagasaki H, Takahashi Y, Muramatsu H, Hama A, Tanaka M, Yoshida N, Watanabe N, Kudo K, Yoshimi A, Kojima S. Late-onset non-infectious pulmonary complications following allogeneic hematopoietic stem cell transplantation in children. Bone Marrow Transplant. 2009 Sep;44(5):303-8. doi: 10.1038/bmt.2009.33. Epub 2009 Apr 6.
PubMed 19349954
Williams KM, Chien JW, Gladwin MT, Pavletic SZ. Bronchiolitis obliterans after allogeneic hematopoietic stem cell transplantation. JAMA. 2009 Jul 15;302(3):306-14. doi: 10.1001/jama.2009.1018.
PubMed 19602690
Sato M, Keshavjee S. Bronchiolitis obliterans syndrome: alloimmune-dependent and -independent injury with aberrant tissue remodeling. Semin Thorac Cardiovasc Surg. 2008 Summer;20(2):173-82. doi: 10.1053/j.semtcvs.2008.05.002.
PubMed 18707652
Duncan CN, Buonanno MR, Barry EV, Myers K, Peritz D, Lehmann L. Bronchiolitis obliterans following pediatric allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jun;41(11):971-5. doi: 10.1038/bmt.2008.19. Epub 2008 Feb 25.
PubMed 18297116
Ditschkowski M, Elmaagacli AH, Trenschel R, Peceny R, Koldehoff M, Schulte C, Beelen DW. T-cell depletion prevents from bronchiolitis obliterans and bronchiolitis obliterans with organizing pneumonia after allogeneic hematopoietic stem cell transplantation with related donors. Haematologica. 2007 Apr;92(4):558-61. doi: 10.3324/haematol.10710.
PubMed 17488669
Huisman C, van der Straaten HM, Canninga-van Dijk MR, Fijnheer R, Verdonck LF. Pulmonary complications after T-cell-depleted allogeneic stem cell transplantation: low incidence and strong association with acute graft-versus-host disease. Bone Marrow Transplant. 2006 Oct;38(8):561-6. doi: 10.1038/sj.bmt.1705484. Epub 2006 Sep 4.
PubMed 16953211
Yoshihara S, Tateishi U, Ando T, Kunitoh H, Suyama H, Onishi Y, Tanosaki R, Mineishi S. Lower incidence of Bronchiolitis obliterans in allogeneic hematopoietic stem cell transplantation with reduced-intensity conditioning compared with myeloablative conditioning. Bone Marrow Transplant. 2005 Jun;35(12):1195-200. doi: 10.1038/sj.bmt.1704985.
PubMed 15852024
Santo Tomas LH, Loberiza FR Jr, Klein JP, Layde PM, Lipchik RJ, Rizzo JD, Bredeson CN, Horowitz MM. Risk factors for bronchiolitis obliterans in allogeneic hematopoietic stem-cell transplantation for leukemia. Chest. 2005 Jul;128(1):153-61. doi: 10.1378/chest.128.1.153.
PubMed 16002929
Xu J, Torres E, Mora AL, Shim H, Ramirez A, Neujahr D, Brigham KL, Rojas M. Attenuation of obliterative bronchiolitis by a CXCR4 antagonist in the murine heterotopic tracheal transplant model. J Heart Lung Transplant. 2008 Dec;27(12):1302-10. doi: 10.1016/j.healun.2008.08.010.
PubMed 19059110
Hildebrandt GC, Granell M, Urbano-Ispizua A, Wolff D, Hertenstein B, Greinix HT, Brenmoehl J, Schulz C, Dickinson AM, Hahn J, Rogler G, Andreesen R, Holler E. Recipient NOD2/CARD15 variants: a novel independent risk factor for the development of bronchiolitis obliterans after allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2008 Jan;14(1):67-74. doi: 10.1016/j.bbmt.2007.09.009.
PubMed 18158963
Medoff BD, Wain JC, Seung E, Jackobek R, Means TK, Ginns LC, Farber JM, Luster AD. CXCR3 and its ligands in a murine model of obliterative bronchiolitis: regulation and function. J Immunol. 2006 Jun 1;176(11):7087-95. doi: 10.4049/jimmunol.176.11.7087.
PubMed 16709871
Jaramillo A, Smith CR, Maruyama T, Zhang L, Patterson GA, Mohanakumar T. Anti-HLA class I antibody binding to airway epithelial cells induces production of fibrogenic growth factors and apoptotic cell death: a possible mechanism for bronchiolitis obliterans syndrome. Hum Immunol. 2003 May;64(5):521-9. doi: 10.1016/s0198-8859(03)00038-7.
PubMed 12691702
Belperio JA, DiGiovine B, Keane MP, Burdick MD, Ying Xue Y, Ross DJ, Lynch JP 3rd, Kunkel SL, Strieter RM. Interleukin-1 receptor antagonist as a biomarker for bronchiolitis obliterans syndrome in lung transplant recipients. Transplantation. 2002 Feb 27;73(4):591-9. doi: 10.1097/00007890-200202270-00020.
PubMed 11889437

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 Graft vs Host Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell Transpantation
ClinicalTrials.gov ID: NCT01327625
Acronym / sponsor ID: AMC-ALLO-041
Conditions: Graft vs Host Disease, Bronchiolitis Obliterans
Keywords: Allogeneic hematopoietic cell transplantation, Graft versus host disease, Bronchiolitis obliterans, Azithromycin, N-acetylcystein, Fluticasone, Inhaled steroid
Study type: Interventional
Recruitment status: TerminatedReason stopped: Preliminary reports of this study was too bad.
Enrolment: 6 participants (actual)
Lead sponsor: Asan Medical CenterUniversity, hospital or other
Study start: Mar 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 1 Apr 2011 (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.

[Study Objectives]

To evaluate the efficacy of azithromycin, N-acetylcystein, and inhaled corticosteroid combination therapy in patients with bronchiolitis obliterans as a complication of allogeneic hematopoietic cell transplantation in terms of response rate at 6 months after treatment initiation based on the improvement of FEV1.

Detailed description

Bronchiolitis obliterans (BO) is a graft-versus-host disease of respiratory organs.
Prognosis of BO is very poor, and the overall outcome of patients who are involved in BO is very dismal.
The mechanism of BO has been known to be associated with immune / non-immune response.
Corticosteroid and immunosuppressants are recommended as a best current treatment options for BO, which have been not satisfactory.
Many treatment options have been tried to improve the outcome of BO.
Azithromycin, as an immune modulating agent, has been tried for the treatment of BO, and has been reported to show hopeful results.
N-acetylcystein, as an antioxidative agent, has been tried for BO.
Inhaled corticosteroid may help to improve airway inflammation and decrease the amount of systemic corticosteroid.
These 3 drugs are widely used for other respiratory disease, have been proven to be safe, and have shown some efficacy for BO in various depth of evidence.
In these rationale, we'd like to try the 3-drug combination for BO, to assess the efficacy and safety of these drug combination.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Azithromycin	Experimental	Drug: azithromycin + N-acetylcystein + inhaled corticosteroidPatient who are diagnosed as bronchiolitis obliterans according to the WHO criteria

Who may qualify

Ages: 15 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Patients who previously received allogeneic hematopoietic cell transplantation due to hematologic malignancy, bone marrow failure syndrome, and other compatible disease.
Patients who are diagnosed as bronchiolitis obliterans (BO) according to the NIH diagnostic guideline which is suggested as below.
Patients should be 15 years of age or older, but younger than 75 years.
Patients should have estimated life expectancy of more than 3 months.
Patients must have adequate hepatic function (bilirubin less than 3.0 ㎎/㎗, AST and ALT less than three times the upper normal limit).

Key exclusion criteria (6 listed)

Presence of significant active infection
Presence of uncontrolled bleeding
Any coexisting major illness or organ failure
Patients with a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception

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
azithromycin + N-acetylcystein + inhaled corticosteroidAlso: Zithromax* Azithromycin 500mg qd x 1 week --> 250mg qod x 6 months * N-acetylcystein 200mg tid x 6 months * Fluticasone 250mcg puff x2/day x 6 months	Drug	Azithromycin

Primary outcome

Response rate based on the improvement of FEV1
Time frame: 6 months
Response rate at 6 months after treatment initiation based on the improvement of FEV1

7 secondary outcomes

Clinical benefit rate based on the degree of change in FEV1
Time frame: 6 months
change in FEV1 compared with pretreatment level
Time frame: 6 months after treatment initiation
Reduction rate in immunosuppressive agent / systemic corticosteroid
Time frame: 6 months after treatment initiation
Discontinuation rate in immunosuppressive agent / systemic corticosteroid
Time frame: 6 months after treatment initiation
Change in dose-intensity of immunosuppressive agent / systemic corticosteroid compared with pretreatment dose-intensity
Time frame: 6 months after treatment initiation
event-free survival
Time frame: 1 year
overall survival
Time frame: 1year

Results and safety

The study was stopped early (reason given: Preliminary reports of this study was too bad.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
Background: PubMed 19442201Patriarca F, Poletti V, Costabel U, Battista ML, Sperotto A, Medeot M, Toffoletti E, Fanin R. Clinical presentation, outcome and risk factors of late-onset non-infectious pulmonary complications after allogeneic stem cell transplantation. Curr Stem Cell Res Ther. 2009 May;4(2):161-7. doi: 10.2174/157488809788167436.
Background: PubMed 16791762Afessa B, Peters SG. Major complications following hematopoietic stem cell transplantation. Semin Respir Crit Care Med. 2006 Jun;27(3):297-309. doi: 10.1055/s-2006-945530.
Background: PubMed 19349954Nishio N, Yagasaki H, Takahashi Y, Muramatsu H, Hama A, Tanaka M, Yoshida N, Watanabe N, Kudo K, Yoshimi A, Kojima S. Late-onset non-infectious pulmonary complications following allogeneic hematopoietic stem cell transplantation in children. Bone Marrow Transplant. 2009 Sep;44(5):303-8. doi: 10.1038/bmt.2009.33. Epub 2009 Apr 6.
Background: PubMed 19602690Williams KM, Chien JW, Gladwin MT, Pavletic SZ. Bronchiolitis obliterans after allogeneic hematopoietic stem cell transplantation. JAMA. 2009 Jul 15;302(3):306-14. doi: 10.1001/jama.2009.1018.
Background: PubMed 18707652Sato M, Keshavjee S. Bronchiolitis obliterans syndrome: alloimmune-dependent and -independent injury with aberrant tissue remodeling. Semin Thorac Cardiovasc Surg. 2008 Summer;20(2):173-82. doi: 10.1053/j.semtcvs.2008.05.002.
Background: PubMed 18297116Duncan CN, Buonanno MR, Barry EV, Myers K, Peritz D, Lehmann L. Bronchiolitis obliterans following pediatric allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jun;41(11):971-5. doi: 10.1038/bmt.2008.19. Epub 2008 Feb 25.
Background: PubMed 17488669Ditschkowski M, Elmaagacli AH, Trenschel R, Peceny R, Koldehoff M, Schulte C, Beelen DW. T-cell depletion prevents from bronchiolitis obliterans and bronchiolitis obliterans with organizing pneumonia after allogeneic hematopoietic stem cell transplantation with related donors. Haematologica. 2007 Apr;92(4):558-61. doi: 10.3324/haematol.10710.
Background: PubMed 16953211Huisman C, van der Straaten HM, Canninga-van Dijk MR, Fijnheer R, Verdonck LF. Pulmonary complications after T-cell-depleted allogeneic stem cell transplantation: low incidence and strong association with acute graft-versus-host disease. Bone Marrow Transplant. 2006 Oct;38(8):561-6. doi: 10.1038/sj.bmt.1705484. Epub 2006 Sep 4.
Background: PubMed 15852024Yoshihara S, Tateishi U, Ando T, Kunitoh H, Suyama H, Onishi Y, Tanosaki R, Mineishi S. Lower incidence of Bronchiolitis obliterans in allogeneic hematopoietic stem cell transplantation with reduced-intensity conditioning compared with myeloablative conditioning. Bone Marrow Transplant. 2005 Jun;35(12):1195-200. doi: 10.1038/sj.bmt.1704985.
Background: PubMed 16002929Santo Tomas LH, Loberiza FR Jr, Klein JP, Layde PM, Lipchik RJ, Rizzo JD, Bredeson CN, Horowitz MM. Risk factors for bronchiolitis obliterans in allogeneic hematopoietic stem-cell transplantation for leukemia. Chest. 2005 Jul;128(1):153-61. doi: 10.1378/chest.128.1.153.
Background: PubMed 19059110Xu J, Torres E, Mora AL, Shim H, Ramirez A, Neujahr D, Brigham KL, Rojas M. Attenuation of obliterative bronchiolitis by a CXCR4 antagonist in the murine heterotopic tracheal transplant model. J Heart Lung Transplant. 2008 Dec;27(12):1302-10. doi: 10.1016/j.healun.2008.08.010.
Background: PubMed 18158963Hildebrandt GC, Granell M, Urbano-Ispizua A, Wolff D, Hertenstein B, Greinix HT, Brenmoehl J, Schulz C, Dickinson AM, Hahn J, Rogler G, Andreesen R, Holler E. Recipient NOD2/CARD15 variants: a novel independent risk factor for the development of bronchiolitis obliterans after allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2008 Jan;14(1):67-74. doi: 10.1016/j.bbmt.2007.09.009.

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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.

Dae-Young Kim, M.D. principal investigator

Asan Medical Center

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

Questions about this trial

What is this clinical trial studying?

A study testing azithromycin + N-acetylcystein + inhaled corticosteroid in people with Graft vs Host Disease and Bronchiolitis Obliterans, run by Asan Medical Center at 1 site in South Korea.

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 6 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: stopped early, as of the sponsor's last update on 9 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 1 site in South Korea. 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 was stopped early (reason given: Preliminary reports of this study was too bad.). Results are not available in the source record.

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?

Response rate based on the improvement of FEV1 (time frame: 6 months). 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 NCT01327625, which also lists 26 linked publications.

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 9 Jul 2014.