AsthmaPhase 3SIENANCT02066298
Steroids In Eosinophil Negative Asthma
A Phase 3 study testing Mometasone 220mcg BID and Tiotropium Respimat 5mcg QD in people with Asthma, run by Milton S. Hershey Medical Center at 25 sites in United States.
Trial summary
Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Mometasone 220mcg BID and Tiotropium Respimat 5mcg QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 25 sitesUnited States
- Study dates
- Jul 2014to May 2018
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physician-diagnosed asthma for at least previous 12 months.
- Able to perform reproducible spirometry.
- Baseline FEV1≥70% of predicted.
- Asthma confirmed either by:
- Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR
- Methacholine PC20 ≤ 16 mg/ml
Show all 12Show fewer
- At least 1 of the following indications for chronic controller therapy:
- Asthma Symptoms > 2 days/week OR
- Nocturnal Asthma Symptoms > 2 nights/month OR
- Short-acting beta-agonist use for symptom control > 2 days/week
- For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.
- Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.
Who cannot join
- Chronic inhaled or oral corticosteroid therapy.
- Use of inhaled or oral corticosteroid therapy within 6 weeks.
- New allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen.
- Use of omalizumab within 3 months.
- History of:
- bladder-neck obstruction, urinary retention or benign prostatic hyperplasia
Show all 12Show fewer
- narrow angle glaucoma
- significant cardiovascular disorders and arrhythmias
- life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years
- Respiratory tract infection within past 6 weeks.
- History of smoking within the past 1 year, or > 10 pack-years total if ≥ 18 years of age, or > 5 pack-years total if < 18 years of age.
- Chronic diseases or medical conditions (other than asthma) that could put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Emory University
Atlanta, Georgia, 30322
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Children's Hospital Boston
Boston, Massachusetts, 02115
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60614
University of Chicago
Chicago, Illinois, 60637
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, 44106
National Jewish Health
Denver, Colorado, 80206
Duke University School of Medicine
Durham, North Carolina, 27110
Nemours Children's Clinic
Jacksonville, Florida, 32207
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Columbia University Medical Center
New York, New York, 10032
Nemours Children's Clinic
Orlando, Florida, 32827
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
North Carolina Clinical Research
Raleigh, North Carolina, 27607
UCSF Benioff Children's Hospital
San Francisco, California, 94143
University of California at San Francisco
San Francisco, California, 94143
St. Louis Children's Hospital
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
University of Arizona College of Medicine
Tucson, Arizona, 85724
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.
Read the detailed description
SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).
- Conditions
- Asthma
- Being tested
- Mometasone 220mcg BID, Tiotropium Respimat 5mcg QD, Placebo
- Keywords
- Asthma, Mometasone, Tiotropium
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone 220mcg BIDDrug
Also called Asmanex
Mometasone is an ICS
Tiotropium Respimat 5mcg QDDrug
Tiotropium is a LMA
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Mometasone then Tiotropium then Placebo | Experimental | Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo Receives: Drug: Mometasone 220mcg BID; Drug: Tiotropium Respimat 5mcg QD; Drug: Placebo |
| Mometasone then Placebo then Tiotropium | Experimental | Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD Receives: Drug: Mometasone 220mcg BID; Drug: Tiotropium Respimat 5mcg QD; Drug: Placebo |
| Placebo then Mometasone then Tiotropium | Experimental | Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD Receives: Drug: Mometasone 220mcg BID; Drug: Tiotropium Respimat 5mcg QD; Drug: Placebo |
| Placebo then Tiotropium then Mometasone | Experimental | Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID Receives: Drug: Mometasone 220mcg BID; Drug: Tiotropium Respimat 5mcg QD; Drug: Placebo |
| Tiotropium then Placebo then Mometasone | Experimental | Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID Receives: Drug: Mometasone 220mcg BID; Drug: Tiotropium Respimat 5mcg QD; Drug: Placebo |
| Tiotropium then Mometasone then Placebo | Experimental | Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo Receives: Drug: Mometasone 220mcg BID; Drug: Tiotropium Respimat 5mcg QD; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1.
This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.
Measured: End of 12-week treatment period
Secondary outcomes (5)
Treatment Failure
Treatment Failure includes:
- Awakening from asthma three or more times in a two-week period or on two consecutive nights, or
- Using albuterol for relief of symptoms four or more times/day for two or more consecutive days, or
- Albuterol has been relieving symptoms for less than four hours after each treatment over a 12-hour period, or
- Using albuterol for relief of symptoms daily for seven days, and this use exceeds two times the weekly use of albuterol in the baseline period, or
- exercise induces unusual breathlessness
Measured: End of 12-week treatment period
Annualized Asthma Control Days
Asthma Control Days (ACD) are based on patient completed electronic daily diaries, and are defined as: A day with no rescue albuterol use (pre-exercise albuterol will not be counted), no non-study asthma medications, no daytime asthma symptoms (shortness of breath, wheezing, chest tightness, phlegm/mucus rated as mild, moderate or severe, or cough rated as moderate or severe), no nighttime asthma symptoms, no unscheduled healthcare visits for asthma, and no PEF < 80% of predetermined baseline. Annualized ACD are calculated as the proportion of ACD during the treatment period multiplied by 365.
Measured: End of 12-week treatment period
Forced Expiratory Volume at One Second (FEV1) Percent of Predicted
FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height.
Measured: End of 12-week treatment period
Peak Expiratory Flow Rate
Peak expiratory flow rate is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways.
Measured: End of 12-week treatment period
Asthma Exacerbations
Asthma exacerbations are more severe episodes of acute worsening, defined by meeting one or more of the following:
- FEV1 <50% of baseline on 2 consecutive measurements
- FEV1 <40% of predicted on 2 consecutive measurements
- Use of ≥ 16 puffs of "as needed" β-agonist per 24 hours for a period of 48 hours
- Use of oral/parenteral corticosteroid due to asthma
Measured: End of 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2018
- Study completionMay 2018
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 (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, dave mauger, Milton S. Hershey Medical Center
- Investigators
- William Busse, M.D., Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066298
- Sponsor's protocol ID
- AsthmaNet 007
- Other IDs
- 1U10HL098115
- Acronym
- SIENA
- Status last verified
- May 2019
- First submitted
- 10 Feb 2014
- Last updated
- 29 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Covar R, Lazarus SC, Krishnan JA, Blake KV, Sorkness CA, Dyer AM, Lang JE, Lugogo NL, Mauger DT, Wechsler ME, Wenzel SE, Cardet JC, Castro M, Israel E, Phipatanakul W, King TS; National Heart, Lung, and Blood Institute AsthmaNet. Association of Sputum Eosinophilia With Easily Measured Type-2 Inflammatory Biomarkers in Untreated Mild Persistent Asthma. J Allergy Clin Immunol Pract. 2024 Apr;12(4):960-969.e6. doi: 10.1016/j.jaip.2023.12.010. Epub 2023 Dec 12.
PubMed 38097180Lazarus SC, Krishnan JA, King TS, Lang JE, Blake KV, Covar R, Lugogo N, Wenzel S, Chinchilli VM, Mauger DT, Dyer AM, Boushey HA, Fahy JV, Woodruff PG, Bacharier LB, Cabana MD, Cardet JC, Castro M, Chmiel J, Denlinger L, DiMango E, Fitzpatrick AM, Gentile D, Hastie A, Holguin F, Israel E, Jackson D, Kraft M, LaForce C, Lemanske RF Jr, Martinez FD, Moore W, Morgan WJ, Moy JN, Myers R, Peters SP, Phipatanakul W, Pongracic JA, Que L, Ross K, Smith L, Szefler SJ, Wechsler ME, Sorkness CA; National Heart, Lung, and Blood Institute AsthmaNet. Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level. N Engl J Med. 2019 May 23;380(21):2009-2019. doi: 10.1056/NEJMoa1814917. Epub 2019 May 19.
PubMed 31112384Sorkness CA, King TS, Dyer AM, Chinchilli VM, Mauger DT, Krishnan JA, Blake K, Castro M, Covar R, Israel E, Kraft M, Lang JE, Lugogo N, Peters SP, Wechsler ME, Wenzel SE, Lazarus SC; National Heart Lung and Blood Institute's "AsthmaNet". Adapting clinical trial design to maintain meaningful outcomes during a multicenter asthma trial in the precision medicine era. Contemp Clin Trials. 2019 Feb;77:98-103. doi: 10.1016/j.cct.2018.12.012. Epub 2018 Dec 27.
PubMed 30593883
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroids In Eosinophil Negative Asthma
- ClinicalTrials.gov ID
- NCT02066298
- Acronym / sponsor ID
- SIENA / AsthmaNet 007
- Conditions
- Asthma
- Keywords
- Asthma, Mometasone, Tiotropium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 18 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.
Detailed description
SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Mometasone then Tiotropium then Placebo | Experimental | Drug: Mometasone 220mcg BID, Drug: Tiotropium Respimat 5mcg QD, Drug: PlaceboMometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo |
| Mometasone then Placebo then Tiotropium | Experimental | Drug: Mometasone 220mcg BID, Drug: Tiotropium Respimat 5mcg QD, Drug: PlaceboMometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD |
| Placebo then Mometasone then Tiotropium | Experimental | Drug: Mometasone 220mcg BID, Drug: Tiotropium Respimat 5mcg QD, Drug: PlaceboPlacebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD |
| Placebo then Tiotropium then Mometasone | Experimental | Drug: Mometasone 220mcg BID, Drug: Tiotropium Respimat 5mcg QD, Drug: PlaceboPlacebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID |
| Tiotropium then Placebo then Mometasone | Experimental | Drug: Mometasone 220mcg BID, Drug: Tiotropium Respimat 5mcg QD, Drug: PlaceboTiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID |
| Tiotropium then Mometasone then Placebo | Experimental | Drug: Mometasone 220mcg BID, Drug: Tiotropium Respimat 5mcg QD, Drug: PlaceboTiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Physician-diagnosed asthma for at least previous 12 months.
- Able to perform reproducible spirometry.
- Baseline FEV1≥70% of predicted.
- Asthma confirmed either by:
- At least 1 of the following indications for chronic controller therapy:
Key exclusion criteria (12 listed)
- Chronic inhaled or oral corticosteroid therapy.
- Use of inhaled or oral corticosteroid therapy within 6 weeks.
- New allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen.
- Use of omalizumab within 3 months.
- History of:
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 |
|---|---|---|
| Mometasone 220mcg BIDAlso: AsmanexMometasone is an ICS | Drug | Mometasone then Placebo then Tiotropium, Mometasone then Tiotropium then Placebo, Placebo then Mometasone then Tiotropium, Placebo then Tiotropium then Mometasone, Tiotropium then Mometasone then Placebo, Tiotropium then Placebo then Mometasone |
| Tiotropium Respimat 5mcg QDTiotropium is a LMA | Drug | Mometasone then Placebo then Tiotropium, Mometasone then Tiotropium then Placebo, Placebo then Mometasone then Tiotropium, Placebo then Tiotropium then Mometasone, Tiotropium then Mometasone then Placebo, Tiotropium then Placebo then Mometasone |
| Placebo | Drug | Mometasone then Placebo then Tiotropium, Mometasone then Tiotropium then Placebo, Placebo then Mometasone then Tiotropium, Placebo then Tiotropium then Mometasone, Tiotropium then Mometasone then Placebo, Tiotropium then Placebo then Mometasone |
Primary outcome
Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1.
Time frame: End of 12-week treatment period
This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.
5 secondary outcomes
Treatment Failure
Time frame: End of 12-week treatment period
Annualized Asthma Control Days
Time frame: End of 12-week treatment period
Forced Expiratory Volume at One Second (FEV1) Percent of Predicted
Time frame: End of 12-week treatment period
Peak Expiratory Flow Rate
Time frame: End of 12-week treatment period
Asthma Exacerbations
Time frame: End of 12-week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38097180Covar R, Lazarus SC, Krishnan JA, Blake KV, Sorkness CA, Dyer AM, Lang JE, Lugogo NL, Mauger DT, Wechsler ME, Wenzel SE, Cardet JC, Castro M, Israel E, Phipatanakul W, King TS; National Heart, Lung, and Blood Institute AsthmaNet. Association of Sputum Eosinophilia With Easily Measured Type-2 Inflammatory Biomarkers in Untreated Mild Persistent Asthma. J Allergy Clin Immunol Pract. 2024 Apr;12(4):960-969.e6. doi: 10.1016/j.jaip.2023.12.010. Epub 2023 Dec 12.
- Derived from this study: PubMed 31112384Lazarus SC, Krishnan JA, King TS, Lang JE, Blake KV, Covar R, Lugogo N, Wenzel S, Chinchilli VM, Mauger DT, Dyer AM, Boushey HA, Fahy JV, Woodruff PG, Bacharier LB, Cabana MD, Cardet JC, Castro M, Chmiel J, Denlinger L, DiMango E, Fitzpatrick AM, Gentile D, Hastie A, Holguin F, Israel E, Jackson D, Kraft M, LaForce C, Lemanske RF Jr, Martinez FD, Moore W, Morgan WJ, Moy JN, Myers R, Peters SP, Phipatanakul W, Pongracic JA, Que L, Ross K, Smith L, Szefler SJ, Wechsler ME, Sorkness CA; National Heart, Lung, and Blood Institute AsthmaNet. Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level. N Engl J Med. 2019 May 23;380(21):2009-2019. doi: 10.1056/NEJMoa1814917. Epub 2019 May 19.
- Derived from this study: PubMed 30593883Sorkness CA, King TS, Dyer AM, Chinchilli VM, Mauger DT, Krishnan JA, Blake K, Castro M, Covar R, Israel E, Kraft M, Lang JE, Lugogo N, Peters SP, Wechsler ME, Wenzel SE, Lazarus SC; National Heart Lung and Blood Institute's "AsthmaNet". Adapting clinical trial design to maintain meaningful outcomes during a multicenter asthma trial in the precision medicine era. Contemp Clin Trials. 2019 Feb;77:98-103. doi: 10.1016/j.cct.2018.12.012. Epub 2018 Dec 27.
- AsthmaNetLink provided by the sponsor.
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Asthma
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.
William Busse, M.D. study chair
University of Wisconsin, Madison
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone 220mcg BID and Tiotropium Respimat 5mcg QD in people with Asthma, run by Milton S. Hershey Medical Center at 25 sites in United States.
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 12 inclusion and 12 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 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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.
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?
Yes. Results are posted in the registry (first posted 18 Apr 2019). 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?
Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. (time frame: End of 12-week treatment period). 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 NCT02066298, which also lists 3 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 29 May 2019.