SinusitisPhase 3NCT02367118
Prednisone in Chronic Rhinosinusitis Without Nasal Polyps
A Phase 3 study testing Prednisone in people with Sinusitis and Chronic Rhinosinusitis, run by University of Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sinusitis, Chronic Rhinosinusitis
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChile
- Study dates
- Jun 2015to Dec 2016
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and Nasal Polyps 2012
Who cannot join
- Treatment with oral corticosteroids or topical corticosteroids the last 4 weeks.
- Previous surgical treatment for CRSsNP
- History of diabetes mellitus and / or glaucoma and / or decompensated hypertension and / or gastric ulcer.
- Pregnancy.
- History of cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, allergic fungal sinusitis, nasal polyps, nasal tumors, hepatic or renal dysfunction.
- Hypersensitivity to prednisone
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital del Salvador
Santiago, Santiago Metropolitan, 7600490
Constanza J Valdes, MD, 56-02-2575-3968, cjvaldes@gmail.com
Marcela A Veloz, MD, 56-02-2575-3968, marceveloz@gmail.com
About this study
Official title: Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial
The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.
Read the detailed description
General Objective:
- Compare clinical improvement in adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) through application of SNOT 22 questionnaire and visual analogue scale of symptoms, sniff test, acoustic rhinometry and rhinomanometry and nasal endoscopy using Lund-Kennedy score, after 6 months of follow-up after treatment prednisone or placebo plus standard medical treatment for 21 days.
Specific Objectives:
- Compare decreased in SNOT-22 questionnaire score and visual analog scale of symptoms after treatment with prednisone or placebo.
- Compare decreased in nasal endoscopy findings, through application of Lund-Kennedy score, after treatment with prednisone or placebo.
- Compare improvements in smell after treatment with prednisone or placebo.
- Determine whether there are differences in nasal permeability measured by rhinomanometry and acoustic rhinometry after treatment with prednisone or placebo.
- Determine whether there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients and eosinophilia, and CRSsNP patients with normal eosinophils, receiving prednisone or placebo .
- Determine if there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients with elevated total immunoglobulin E and CRSsNP patients with normal total immunoglobulin E, receiving treatment with prednisone or placebo.
- Conditions
- Sinusitis, Chronic Rhinosinusitis
- Being tested
- Prednisone, Placebo
- Keywords
- chronic rhinosinusitis without nasal polyps prednisone
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Experimental | Intervention: prednisone 5 mg tablets taken orally, in decreasing doses. Beginning with 6 tablets (30 mg) daily for 7 days, then 3 tablets (15 mg) daily for 7 days, then 1 tablet (5 mg) daily for 7 days. Total days of treatment: 21 days. Receives: Drug: Prednisone |
| Placebo | Placebo comparator | Intervention: placebo tablets taken orally (similar to prednisone), in decreasing doses. Beginning with 6 tablets daily for 7 days, then 3 tablets daily for 7 days, then 1 tablet daily for 7 days. Total days of treatment: 21 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 months
Measured: Improvement in symptoms at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Change in Olfactory function as measured by "Sniffin'Sticks 12 tests" at 6 months
Measured: Improvement in Olfactory function at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months
Measured: Improvement in nasal patency at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Changes in Nasal endoscopy findings as measured by Lund-Kennedy score at 6 months
Measured: Changes in nasal endoscopy findings at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello
- Responsible party
- Principal investigator, Constanza J. Valdes, University of Chile
- Investigators
- Constanza J Valdes, MD, Study director, University of ChileMarcela A Veloz, MD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367118
- Sponsor's protocol ID
- PRD- CRSsNP-1
- Status last verified
- Jun 2015
- First submitted
- 8 Feb 2015
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bhattacharyya N, Orlandi RR, Grebner J, Martinson M. Cost burden of chronic rhinosinusitis: a claims-based study. Otolaryngol Head Neck Surg. 2011 Mar;144(3):440-5. doi: 10.1177/0194599810391852. Epub 2011 Feb 3.
PubMed 21493210Dubin MG, Liu C, Lin SY, Senior BA. American Rhinologic Society member survey on "maximal medical therapy" for chronic rhinosinusitis. Am J Rhinol. 2007 Jul-Aug;21(4):483-8. doi: 10.2500/ajr.2007.21.3047.
PubMed 17882920Mullol J, Obando A, Pujols L, Alobid I. Corticosteroid treatment in chronic rhinosinusitis: the possibilities and the limits. Immunol Allergy Clin North Am. 2009 Nov;29(4):657-68. doi: 10.1016/j.iac.2009.07.001.
PubMed 19879441Takeda K, Takeno S, Hirakawa K, Ishino T. Expression and distribution of glucocorticoid receptor isoforms in eosinophilic chronic rhinosinusitis. Auris Nasus Larynx. 2010 Dec;37(6):700-7. doi: 10.1016/j.anl.2010.03.005. Epub 2010 May 21.
PubMed 20488636Benitez P, Alobid I, de Haro J, Berenguer J, Bernal-Sprekelsen M, Pujols L, Picado C, Mullol J. A short course of oral prednisone followed by intranasal budesonide is an effective treatment of severe nasal polyps. Laryngoscope. 2006 May;116(5):770-5. doi: 10.1097/01.mlg.0000205218.37514.0f.
PubMed 16652085Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.
PubMed 7574265Kobal G, Klimek L, Wolfensberger M, Gudziol H, Temmel A, Owen CM, Seeber H, Pauli E, Hummel T. Multicenter investigation of 1,036 subjects using a standardized method for the assessment of olfactory function combining tests of odor identification, odor discrimination, and olfactory thresholds. Eur Arch Otorhinolaryngol. 2000;257(4):205-11. doi: 10.1007/s004050050223.
PubMed 10867835Poetker DM, Reh DD. A comprehensive review of the adverse effects of systemic corticosteroids. Otolaryngol Clin North Am. 2010 Aug;43(4):753-68. doi: 10.1016/j.otc.2010.04.003.
PubMed 20599080Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wohrl S, Maibach H, Lockey R. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1;3(1):3. doi: 10.1186/2045-7022-3-3.
PubMed 23369181Chaves C, de Andrade CR, Ibiapina C. Objective measures for functional diagnostic of the upper airways: practical aspects. Rhinology. 2014 Jun;52(2):99-103. doi: 10.4193/Rhino13.109.
PubMed 24932618Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl. 2012 Mar;23:3 p preceding table of contents, 1-298.
PubMed 22764607Orlandi RR, Smith TL, Marple BF, Harvey RJ, Hwang PH, Kern RC, Kingdom TT, Luong A, Rudmik L, Senior BA, Toskala E, Kennedy DW. Update on evidence-based reviews with recommendations in adult chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Jul;4 Suppl 1:S1-S15. doi: 10.1002/alr.21344. Epub 2014 May 29.
PubMed 24889751Baguley C, Brownlow A, Yeung K, Pratt E, Sacks R, Harvey R. The fate of chronic rhinosinusitis sufferers after maximal medical therapy. Int Forum Allergy Rhinol. 2014 Jul;4(7):525-32. doi: 10.1002/alr.21315. Epub 2014 Mar 7.
PubMed 24610673Watanabe S, Pinto JM, Bashir ME, De Tineo M, Suzaki H, Baroody FM, Naclerio RM, Sharma S. Effect of prednisone on nasal symptoms and peripheral blood T-cell function in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Aug;4(8):609-16. doi: 10.1002/alr.21336. Epub 2014 Apr 21.
PubMed 24753507Poetker DM, Jakubowski LA, Lal D, Hwang PH, Wright ED, Smith TL. Oral corticosteroids in the management of adult chronic rhinosinusitis with and without nasal polyps: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013 Feb;3(2):104-20. doi: 10.1002/alr.21072. Epub 2012 Aug 7.
PubMed 22887970
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02367118
- Acronym / sponsor ID
- PRD- CRSsNP-1
- Conditions
- Sinusitis, Chronic Rhinosinusitis
- Keywords
- chronic rhinosinusitis without nasal polyps prednisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Feb 2015 (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.
The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.
Detailed description
General Objective:
- Compare clinical improvement in adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) through application of SNOT 22 questionnaire and visual analogue scale of symptoms, sniff test, acoustic rhinometry and rhinomanometry and nasal endoscopy using Lund-Kennedy score, after 6 months of follow-up after treatment prednisone or placebo plus standard medical treatment for 21 days.
Specific Objectives:
- Compare decreased in SNOT-22 questionnaire score and visual analog scale of symptoms after treatment with prednisone or placebo.
- Compare decreased in nasal endoscopy findings, through application of Lund-Kennedy score, after treatment with prednisone or placebo.
- Compare improvements in smell after treatment with prednisone or placebo.
- Determine whether there are differences in nasal permeability measured by rhinomanometry and acoustic rhinometry after treatment with prednisone or placebo.
- Determine whether there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients and eosinophilia, and CRSsNP patients with normal eosinophils, receiving prednisone or placebo .
- Determine if there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients with elevated total immunoglobulin E and CRSsNP patients with normal total immunoglobulin E, receiving treatment with prednisone or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Experimental | Drug: PrednisoneIntervention: prednisone 5 mg tablets taken orally, in decreasing doses. Beginning with 6 tablets (30 mg) daily for 7 days, then 3 tablets (15 mg) daily for 7 days, then 1 tablet (5 mg) daily for 7 days. Total days of treatment: 21 days. |
| Placebo | Placebo comparator | Drug: PlaceboIntervention: placebo tablets taken orally (similar to prednisone), in decreasing doses. Beginning with 6 tablets daily for 7 days, then 3 tablets daily for 7 days, then 1 tablet daily for 7 days. Total days of treatment: 21 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and Nasal Polyps 2012
Key exclusion criteria (6 listed)
- Treatment with oral corticosteroids or topical corticosteroids the last 4 weeks.
- Previous surgical treatment for CRSsNP
- History of diabetes mellitus and / or glaucoma and / or decompensated hypertension and / or gastric ulcer.
- Pregnancy.
- History of cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, allergic fungal sinusitis, nasal polyps, nasal tumors, hepatic or renal dysfunction.
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 |
|---|---|---|
| Prednisone | Drug | Prednisone |
| Placebo | Drug | Placebo |
Primary outcome
Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 months
Time frame: Improvement in symptoms at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Change in Olfactory function as measured by "Sniffin'Sticks 12 tests" at 6 months
Time frame: Improvement in Olfactory function at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months
Time frame: Improvement in nasal patency at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Changes in Nasal endoscopy findings as measured by Lund-Kennedy score at 6 months
Time frame: Changes in nasal endoscopy findings at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Background: PubMed 21493210Bhattacharyya N, Orlandi RR, Grebner J, Martinson M. Cost burden of chronic rhinosinusitis: a claims-based study. Otolaryngol Head Neck Surg. 2011 Mar;144(3):440-5. doi: 10.1177/0194599810391852. Epub 2011 Feb 3.
- Background: PubMed 17882920Dubin MG, Liu C, Lin SY, Senior BA. American Rhinologic Society member survey on "maximal medical therapy" for chronic rhinosinusitis. Am J Rhinol. 2007 Jul-Aug;21(4):483-8. doi: 10.2500/ajr.2007.21.3047.
- Background: PubMed 19879441Mullol J, Obando A, Pujols L, Alobid I. Corticosteroid treatment in chronic rhinosinusitis: the possibilities and the limits. Immunol Allergy Clin North Am. 2009 Nov;29(4):657-68. doi: 10.1016/j.iac.2009.07.001.
- Background: PubMed 20488636Takeda K, Takeno S, Hirakawa K, Ishino T. Expression and distribution of glucocorticoid receptor isoforms in eosinophilic chronic rhinosinusitis. Auris Nasus Larynx. 2010 Dec;37(6):700-7. doi: 10.1016/j.anl.2010.03.005. Epub 2010 May 21.
- Background: PubMed 16652085Benitez P, Alobid I, de Haro J, Berenguer J, Bernal-Sprekelsen M, Pujols L, Picado C, Mullol J. A short course of oral prednisone followed by intranasal budesonide is an effective treatment of severe nasal polyps. Laryngoscope. 2006 May;116(5):770-5. doi: 10.1097/01.mlg.0000205218.37514.0f.
- Background: PubMed 7574265Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.
- Background: PubMed 10867835Kobal G, Klimek L, Wolfensberger M, Gudziol H, Temmel A, Owen CM, Seeber H, Pauli E, Hummel T. Multicenter investigation of 1,036 subjects using a standardized method for the assessment of olfactory function combining tests of odor identification, odor discrimination, and olfactory thresholds. Eur Arch Otorhinolaryngol. 2000;257(4):205-11. doi: 10.1007/s004050050223.
- Background: PubMed 20599080Poetker DM, Reh DD. A comprehensive review of the adverse effects of systemic corticosteroids. Otolaryngol Clin North Am. 2010 Aug;43(4):753-68. doi: 10.1016/j.otc.2010.04.003.
- Background: PubMed 23369181Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wohrl S, Maibach H, Lockey R. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1;3(1):3. doi: 10.1186/2045-7022-3-3.
- Background: PubMed 24932618Chaves C, de Andrade CR, Ibiapina C. Objective measures for functional diagnostic of the upper airways: practical aspects. Rhinology. 2014 Jun;52(2):99-103. doi: 10.4193/Rhino13.109.
- Results publication: PubMed 22764607Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Rhinol Suppl. 2012 Mar;23:3 p preceding table of contents, 1-298.
- Results publication: PubMed 24889751Orlandi RR, Smith TL, Marple BF, Harvey RJ, Hwang PH, Kern RC, Kingdom TT, Luong A, Rudmik L, Senior BA, Toskala E, Kennedy DW. Update on evidence-based reviews with recommendations in adult chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Jul;4 Suppl 1:S1-S15. doi: 10.1002/alr.21344. Epub 2014 May 29.
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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.
Constanza J Valdes, MD study director
University of Chile
Marcela A Veloz, MD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisone in people with Sinusitis and Chronic Rhinosinusitis, run by University of Chile at 1 site in Chile.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Jun 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 Chile. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Constanza J Valdes, MD (56-02-2575-3968, cjvaldes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 months (time frame: Improvement in symptoms at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo). The study lists 4 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 NCT02367118, which also lists 16 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 4 Jun 2015.