AsthmaNCT00231114
Asthma Intervention Research 2 (AIR2) Trial
A study testing Alair System in people with Asthma, run by Boston Scientific Corporation at 39 sites in 7 countries.
Trial summary
The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Alair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 39 sitesin 7 countries
- Study dates
- Sep 2005to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is an adult between the ages of 18 to 65 years.
- Subject has asthma and is taking regular maintenance medication that includes Inhaled corticosteroid (ICS) AND long acting ß2-agonist (LABA).
- Subject has a Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
- Subject has a PC20 < 8 mg/ml per methacholine inhalation test using standardized methods. PC20 is a provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline.
- Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period.
- Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
Who cannot join
- Subject has a Post-bronchodilator FEV1 of less than 65%.
- Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; OR a history of life-threatening asthma, defined by past intubations for asthma, or ICU admission for asthma within the prior 24 months.
- Subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
- Subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
- Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
- Subject has known systemic hypersensitivity or contraindication to Methacholine chloride or other parasympathomimetic agents.
- Subject has other medical criteria.
Trial locations and contacts
39 sites in 7 countries.
39 sites in 7 countries
United States22 sites
Virginia Hospital Center
Arlington, Virginia, 22205-3698
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Brigham and Womens's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
National Jewish Medical and Research Center
Denver, Colorado, 80206
Henry Ford Medical Center
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Clinical Research Solutions, PC - Baptist Hospitals of East Tennesse
Knoxville, Tennessee, 37920
University of Southern California, Adult Asthma and Allergy Center
Los Angeles, California, 90033
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Saint Vincent Catholic Medical Center
New York, New York, 10011
Peoria Pulmonary Associates, Ltd.
Peoria, Illinois, 61603
Hospital of the University of Pennyslvania
Philadelphia, Pennsylvania, 19104
Pulmonary Associates, PA
Phoenix, Arizona, 85020
HealthPartners Specialty Center, Lung and Sleep Health
Saint Paul, Minnesota, 55101
Swedish Medical Center
Seattle, Washington, 98104
Washington University School of Medicine
St Louis, Missouri, 63110-1093
Veritas Clinical Specialties
Topeka, Kansas, 66606
United Kingdom5 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Gartnavel General Hospital, University of Glasgow
Glasgow, Scotland, G12 0YN
Glenfield General Hospital, Univ. Hospitals of Leicester
Leicester, LE3 9QP
Chelsea & Westminster Healthcare NHS Trust
London, SW10 9NH
Northwest Lung Research Center, Univ. of Manchester
Manchester, M23 9LT
Brazil4 sites
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, CEP 90610-00
Irmandade Santa Casa de Miscericordia de Porto Alegre
Porto Alegre, CEP 90035-074
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro
Faculdade da Medicina do ABC
São Paulo, CEP 09060-650
Australia3 sites
Royal Adelaide Hospital
Adelaide
John Hunter Hospital
New Lambton Heights, New South Wales, 2035
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Canada3 sites
Firestone Institute of Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Montreal Chest Institute, McGill University
Montreal, Quebec, H2X 2P4
Hopital Laval, Centre de Pneumologie
Sainte-Foy, Quebec, G1V 4GS
Denmark1 site
Odense Universitets Hospital, University of Odense
Odense, 5000 Odense C
About this study
Official title: Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists.
The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits.
Read more
All other outcome measures assessed at 12 months post-treatment.
This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).
A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).
- Conditions
- Asthma
- Being tested
- Alair System
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alair SystemDevice
Treatment of airways with the Alair System
Alair SystemDevice
Sham treatment of airways with the Alair System
| Study group | Role | What they receive |
|---|---|---|
| Alair | Experimental | Treatment of airways with the Alair System Receives: Device: Alair System |
| Sham | Sham comparator | Sham treatment of airways Receives: Device: Alair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score."
Measured: Baseline, 12 Months
Secondary outcomes (8)
Percent Symptom-Free Days (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime.
Measured: Baseline, 12 Months
Total Symptom Score (Change From Baseline)
Change from Baseline and 12-month Follow-Up Visit. Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.
Measured: Baseline, 12 Months
Number of Puffs of Rescue Medication Used (Change From Baseline)
Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Measured: Baseline, 12 Months
Percent Days Rescue Medication Used (Change From Baseline)
Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Measured: Baseline, 12 Months
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient's FEV1 value (% Predicted) that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control.
Measured: Baseline, 12 Months
Morning Peak Expiratory Flow (amPEF) (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air.
Measured: Baseline, 12 Months
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Measured: Baseline, 12 Months
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Measured: Baseline, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionAug 2008
- Study completionApr 2013
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Narinder S Shargill, PhD, Study director, Asthmatx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231114
- Sponsor's protocol ID
- 04-02
- Status last verified
- Mar 2014
- First submitted
- 30 Sep 2005
- Last updated
- 27 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Pavord ID, Thomson NC, Niven RM, Corris PA, Chung KF, Cox G, Armstrong B, Shargill NS, Laviolette M; Research in Severe Asthma Trial Study Group. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. 2013 Nov;111(5):402-7. doi: 10.1016/j.anai.2013.05.002. Epub 2013 Jun 13.
PubMed 24125149Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth K, Kline JN, Mansur AH, Louie BE, Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013 Aug 30.
PubMed 23998657Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8.
PubMed 19815809Castro M, Rubin A, Laviolette M, Hanania NA, Armstrong B, Cox G; AIR2 Trial Study Group. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Ann Allergy Asthma Immunol. 2011 Jul;107(1):65-70. doi: 10.1016/j.anai.2011.03.005. Epub 2011 Apr 14.
PubMed 21704887
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
- ClinicalTrials.gov ID
- NCT00231114
- Acronym / sponsor ID
- 04-02
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Posted 29 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists.
The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits.
All other outcome measures assessed at 12 months post-treatment.
This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).
A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alair | Experimental | Device: Alair SystemTreatment of airways with the Alair System |
| Sham | Sham comparator | Device: Alair SystemSham treatment of airways |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is an adult between the ages of 18 to 65 years.
- Subject has asthma and is taking regular maintenance medication that includes Inhaled corticosteroid (ICS) AND long acting ß2-agonist (LABA).
- Subject has a Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
- Subject has a PC20 < 8 mg/ml per methacholine inhalation test using standardized methods. PC20 is a provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline.
- Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period.
Key exclusion criteria (7 listed)
- Subject has a Post-bronchodilator FEV1 of less than 65%.
- Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; OR a history of life-threatening asthma, defined by past intubations for asthma, or ICU admission for asthma within the prior 24 months.
- Subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
- Subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
- Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
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 |
|---|---|---|
| Alair SystemTreatment of airways with the Alair System | Device | Alair |
| Alair SystemSham treatment of airways with the Alair System | Device | Sham |
Primary outcome
Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Time frame: Baseline, 12 Months
Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score."
8 secondary outcomes
Percent Symptom-Free Days (Change From Baseline)
Time frame: Baseline, 12 Months
Total Symptom Score (Change From Baseline)
Time frame: Baseline, 12 Months
Number of Puffs of Rescue Medication Used (Change From Baseline)
Time frame: Baseline, 12 Months
Percent Days Rescue Medication Used (Change From Baseline)
Time frame: Baseline, 12 Months
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Time frame: Baseline, 12 Months
Morning Peak Expiratory Flow (amPEF) (Change From Baseline)
Time frame: Baseline, 12 Months
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Time frame: Baseline, 12 Months
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Time frame: Baseline, 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24125149Pavord ID, Thomson NC, Niven RM, Corris PA, Chung KF, Cox G, Armstrong B, Shargill NS, Laviolette M; Research in Severe Asthma Trial Study Group. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. 2013 Nov;111(5):402-7. doi: 10.1016/j.anai.2013.05.002. Epub 2013 Jun 13.
- Results publication: PubMed 23998657Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth K, Kline JN, Mansur AH, Louie BE, Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013 Aug 30.
- Results publication: PubMed 19815809Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8.
- Derived from this study: PubMed 21704887Castro M, Rubin A, Laviolette M, Hanania NA, Armstrong B, Cox G; AIR2 Trial Study Group. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Ann Allergy Asthma Immunol. 2011 Jul;107(1):65-70. doi: 10.1016/j.anai.2011.03.005. Epub 2011 Apr 14.
- The AIR2 Extension Study (PAS1) contains the Year 2 to Year 5 Study Results.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Narinder S Shargill, PhD study director
Asthmatx, Inc.
39 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alair System in people with Asthma, run by Boston Scientific Corporation at 39 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, United Kingdom, Brazil, Australia, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2010). 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?
Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) (time frame: Baseline, 12 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 NCT00231114, which also lists 4 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 27 Jul 2017.