AsthmaPhase 3APRIL - OCELOTNCT01272635

Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.

A Phase 3 study testing Azithromycin and Prednisolone in people with Asthma and Wheezing, run by Milton S. Hershey Medical Center at 16 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. Read more about this study

Who is it for?: Ages 12 to 71 months
Conditions the study is for: Asthma, Wheezing
What is being tested?: Azithromycin and Prednisolone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 607 participants
Where: 16 sitesUnited States
Study dates: Mar 2011to Jan 2015
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 to 71 months
All sexes
No healthy volunteers
Child

Who may be able to join

12-71 months of age.
Recurrent significant wheezing in the past year (any of the following):
>3 episodes, ≥1 of which was clinically significant*; OR
>2 clinically significant* episodes; OR
>4 months of daily controller therapy AND >1 clinically significant* episode.
* Clinically significant episode: requiring any of the following: (1) systemic corticosteroids (oral or injectable), (2) unscheduled physician office visit, (3) ED visit, (4) urgent care visit, or (5) hospitalization.
Up to date with immunizations, including varicella (unless the subject has already had clinical varicella). If the subject needs varicella vaccine, this will be arranged with the primary care physician and must be received prior to randomization.
Willingness to provide informed consent by the child's parent or guardian.

Who cannot join

Participants who meet any of the following criteria are NOT eligible for enrollment, but may be re-enrolled if these exclusion criteria are resolved:
>4 courses of systemic corticosteroids in past 12 months.
More than 1 hospitalization for wheezing illnesses within the preceding 12 months.
Use of long-term controller medications for asthma, including inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil, or theophylline for more than 8 months (cumulative use) in the past 12 months.
Current use of higher than step 2 NAEPP asthma guideline therapy (e.g. medium-high dose ICS alone or combination therapy of low-medium-high dose ICS + LABA, montelukast, theophylline or cromolyn). NOTE: children who have evidence of well-controlled symptoms immediately preceding study entry while receiving Step 2 controller therapy (presence of self-reported symptoms on average no more than 2 times per week and less than 2 nights per month of nocturnal awakenings, requiring albuterol, during the 4 weeks preceding visit 1) may be enrolled and will have their controller therapy discontinued upon study entry.
Use of OCS in the past 2 weeks.

Show all 24Show fewer

Daily symptoms or >2 nocturnal awakenings, requiring albuterol, on average in the last 2 weeks.
Use of antibiotics in the past month.
Current treatment with antibiotics for diagnosed sinus disease.
Participation presently or in the past month in another investigational drug trial.
Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.
Contraindication of use of systemic corticosteroids or azithromycin.
Clinically relevant gastroesophageal reflux.
Concurrent medical conditions other than asthma that are likely to require oral or injectable corticosteroids during the study.
If receiving allergy shots, change in dose within the past 3 months.
Participants who meet any of the following criteria are NOT eligible for enrollment, and may not be re-enrolled:
Gestation less than late preterm as defined as birth before 34 weeks gestational age.
Presence of lung disease other than asthma, such as cystic fibrosis and BPD. Evaluation during the screening process will assure that an adequate evaluation of other lung diseases has been performed.
Presence of other significant medical illnesses (cardiac, liver, gastrointestinal, endocrine) that would place the study subject at increased risk of participating in the study.
Immunodeficiency disorders.
History of respiratory failure requiring mechanical ventilation.
History of hypoxic seizure.
History of significant adverse reaction to any study medication ingredient.
The child has significant developmental delay/failure to thrive, defined as crossing of two major percentile lines during the last year for age and gender. If a child plots less than the 10th percentile for age and gender, a growth chart for the previous year will be obtained from the child's primary care provider.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30322
Children's Hospital Boston
Boston, Massachusetts, 02115
University of Virginia Health System
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
Children's Memorial Hospital
Chicago, Illinois, 60614
University of Chicago
Chicago, Illinois, 60637
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
National Jewish Health
Denver, Colorado, 80206
University of Wisconsin
Madison, Wisconsin, 53972
Center for Urban Population Health
Milwaukee, Wisconsin, 53223
Children's Hospital & Research Center Oakland
Oakland, California, 94609
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
UCSF Benioff Children's Hospital
San Francisco, California, 94143
St. Louis Children's Hospital
St Louis, Missouri, 63110
University of Arizona College of Medicine
Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children

Read the detailed description

Preschool aged children often have severe bouts of coughing and/or wheezing that lead to visits to the doctor's office, urgent care, emergency room and often hospitalization. APRIL-OCELOT is a randomized, double-blind, placebo controlled study in 600 preschool children with a history of significant wheezing episodes in the year prior to enrollment. All children enter the APRIL portion of the study, which will compare azithromycin to placebo, given for 5 days during the early signs of an upper respiratory tract illness, for preventing the development of lower respiratory tract symptoms. APRIL is a 78 week study, but participation will end earlier if the child requires a fourth course of APRIL treatment or develops significant lower respiratory tract symptoms. Only those children who develop significant lower respiratory tract symptoms during APRIL will enter the OCELOT portion of the study, which will compare oral corticosteroid to placebo for treating lower respiratory tract symptoms as measured by the Pediatric Respiratory Assessment Measure (PRAM). OCELOT participation will be complete after 14 days. Children may not reenter APRIL after completing OCELOT.

Conditions: Asthma, Wheezing
Being tested: Azithromycin, Prednisolone, Placebo Azithromycin, Placebo Prednisolone
Keywords: Asthma, Wheezing, Respiratory Tract Illness, Azythromycin, Prednisolone, Preschool-age
Medical subject headings: Asthma, Respiratory Sounds

What participants receive

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

AzithromycinDrug
Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
PrednisoloneDrug
Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
Placebo AzithromycinOther
Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
Placebo PrednisoloneDrug
Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

Study groups in NCT01272635
Study group	Role	What they receive
Azythromycin (APRIL) and Prednisolone (OCELOT)	Experimental	Not described Receives: Drug: Azithromycin; Drug: Prednisolone
Azythromycin (APRIL) and Placebo (OCELOT)	Experimental	Not described Receives: Drug: Azithromycin; Drug: Placebo Prednisolone
Placebo (APRIL) and Prednisolone (OCELOT)	Experimental	Not described Receives: Drug: Prednisolone; Other: Placebo Azithromycin
Placebo (APRIL) and Placebo (OCELOT)	Placebo comparator	Not described Receives: Other: Placebo Azithromycin; Drug: Placebo Prednisolone

What is being measured

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

Progression to Clinically Significant Lower Respiratory Tract Symptoms
Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated.
Measured: 14 days after initiation of APRIL therapy
OCELOT: Pediatric Respiratory Assessment Measure
The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80.
Measured: 36-72 hours after initiation of OCELOT therapy

Secondary outcomes (4)

Asthma Related Symptoms Among RTI Progressing to Severe LRTI
Asthma related symptoms as measured by the parent-completed Pre-school Asthma Symptom Diary (PAD). The PAD was completed daily starting on the first day of an illness and continued until the participant was symptom-free for 2 days. It contains questions of frequency of respiratory symptoms, each scored on a scale of 1 through 7, with higher scores representing increasingly frequent symptoms, with daily scores ranging from 0 (asymptomatic) to a maximum of 102. The total PAD score is the sum of the daily individual symptom scores over the duration of the illness, with higher scores representing more frequent symptoms.
Measured: 14 days after initiation of therapy
Absence From School, Daycare, and/or Parental Work
Measured: 14 days after initiation of therapy
Urgent Care Visits, ED Visits and Hospitalizations
Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms.
Measured: 14 days after initiation of therapy
Drug Related Side Effects
Parent-reported gastrointestinal symptoms during treated RTI.
Measured: 14 days after initiation of therapy

Timeline

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

Mar 2011Jan 2015

First posted10 Jan 2011 (estimated)
Study startMar 2011
Primary completionJan 2015
Study completionJan 2015

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 (2)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Milton S. Hershey 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 607 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01272635
Sponsor's protocol ID: AsthmaNet 002
Other IDs: 1U10HL098115
Acronym: APRIL - OCELOT
Status last verified: Nov 2016
First submitted: 7 Jan 2011
Last updated: 28 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fitzpatrick AM, Grunwell JR, Cottrill KA, Mutic AD, Mauger DT. Blood Eosinophils for Prediction of Exacerbation in Preschool Children With Recurrent Wheezing. J Allergy Clin Immunol Pract. 2023 May;11(5):1485-1493.e8. doi: 10.1016/j.jaip.2023.01.037. Epub 2023 Feb 3.
PubMed 36738927
Bacharier LB, Guilbert TW, Mauger DT, Boehmer S, Beigelman A, Fitzpatrick AM, Jackson DJ, Baxi SN, Benson M, Burnham CD, Cabana M, Castro M, Chmiel JF, Covar R, Daines M, Gaffin JM, Gentile DA, Holguin F, Israel E, Kelly HW, Lazarus SC, Lemanske RF Jr, Ly N, Meade K, Morgan W, Moy J, Olin T, Peters SP, Phipatanakul W, Pongracic JA, Raissy HH, Ross K, Sheehan WJ, Sorkness C, Szefler SJ, Teague WG, Thyne S, Martinez FD. Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in Preschool Children With a History of Such Illnesses: A Randomized Clinical Trial. JAMA. 2015 Nov 17;314(19):2034-2044. doi: 10.1001/jama.2015.13896.
PubMed 26575060

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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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children
ClinicalTrials.gov ID: NCT01272635
Acronym / sponsor ID: APRIL - OCELOT / AsthmaNet 002
Conditions: Asthma, Wheezing
Keywords: Asthma, Wheezing, Respiratory Tract Illness, Azythromycin, Prednisolone, Preschool-age
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 607 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Mar 2011
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 10 Jan 2011 (estimated)
Results: Posted 28 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Azythromycin (APRIL) and Prednisolone (OCELOT)	Experimental	Drug: Azithromycin, Drug: Prednisolone
Azythromycin (APRIL) and Placebo (OCELOT)	Experimental	Drug: Azithromycin, Drug: Placebo Prednisolone
Placebo (APRIL) and Prednisolone (OCELOT)	Experimental	Drug: Prednisolone, Other: Placebo Azithromycin
Placebo (APRIL) and Placebo (OCELOT)	Placebo comparator	Other: Placebo Azithromycin, Drug: Placebo Prednisolone

Who may qualify

Ages: 12 to 71 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

12-71 months of age.
Recurrent significant wheezing in the past year (any of the following):
Up to date with immunizations, including varicella (unless the subject has already had clinical varicella). If the subject needs varicella vaccine, this will be arranged with the primary care physician and must be received prior to randomization.
Willingness to provide informed consent by the child's parent or guardian.

Key exclusion criteria (24 listed)

Participants who meet any of the following criteria are NOT eligible for enrollment, but may be re-enrolled if these exclusion criteria are resolved:
>4 courses of systemic corticosteroids in past 12 months.
More than 1 hospitalization for wheezing illnesses within the preceding 12 months.
Use of long-term controller medications for asthma, including inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil, or theophylline for more than 8 months (cumulative use) in the past 12 months.
Current use of higher than step 2 NAEPP asthma guideline therapy (e.g. medium-high dose ICS alone or combination therapy of low-medium-high dose ICS + LABA, montelukast, theophylline or cromolyn). NOTE: children who have evidence of well-controlled symptoms immediately preceding study entry while receiving Step 2 controller therapy (presence of self-reported symptoms on average no more than 2 times per week and less than 2 nights per month of nocturnal awakenings, requiring albuterol, during the 4 weeks preceding visit 1) may be enrolled and will have their controller therapy discontinued upon study entry.

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
AzithromycinSuspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day	Drug	Azythromycin (APRIL) and Placebo (OCELOT), Azythromycin (APRIL) and Prednisolone (OCELOT)
PrednisoloneSyrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day	Drug	Azythromycin (APRIL) and Prednisolone (OCELOT), Placebo (APRIL) and Prednisolone (OCELOT)
Placebo AzithromycinSuspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day	Other	Placebo (APRIL) and Placebo (OCELOT), Placebo (APRIL) and Prednisolone (OCELOT)
Placebo PrednisoloneSyrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day	Drug	Azythromycin (APRIL) and Placebo (OCELOT), Placebo (APRIL) and Placebo (OCELOT)

Primary outcome

Progression to Clinically Significant Lower Respiratory Tract Symptoms
Time frame: 14 days after initiation of APRIL therapy
Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated.
OCELOT: Pediatric Respiratory Assessment Measure
Time frame: 36-72 hours after initiation of OCELOT therapy
The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80.

4 secondary outcomes

Asthma Related Symptoms Among RTI Progressing to Severe LRTI
Time frame: 14 days after initiation of therapy
Absence From School, Daycare, and/or Parental Work
Time frame: 14 days after initiation of therapy
Urgent Care Visits, ED Visits and Hospitalizations
Time frame: 14 days after initiation of therapy
Drug Related Side Effects
Time frame: 14 days after initiation of therapy

Results and safety

Results posted to the registry on 28 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azithromycin/Prednisolone	153	122
Azithromycin/Placebo	154	134
Placebo/Prednisolone	148	117
Placebo/Placebo	152	129

Primary outcome: Progression to Clinically Significant Lower Respiratory Tract Symptoms

Time frame: 14 days after initiation of APRIL therapy. Number. Unit: participants

Measure	Azythromycin n = 223	Placebo n = 220
Value	35	57

Azythromycin vs Placebo: Hazard Ratio (HR): 0.64 (95% CI 0.41 to 0.98), p = 0.04, Discrete time survival analysis

Population analysed: All participants who initiated APRIL therapy

Primary outcome: OCELOT: Pediatric Respiratory Assessment Measure

Time frame: 36-72 hours after initiation of OCELOT therapy. Mean (Standard Deviation). Unit: PRAM score

Measure	Prednisone n = 23	Placebo n = 21
Value	0.82 (1.49)	1.00 (1.41)

Population analysed: Participants who developed severe lower respiratory tract infections and initiate blinded OCELOT therapy.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azythromycin	18 of 307 (5.9%)	179 of 307 (58.3%)	Not reported
Placebo	15 of 300 (5%)	180 of 300 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36738927Fitzpatrick AM, Grunwell JR, Cottrill KA, Mutic AD, Mauger DT. Blood Eosinophils for Prediction of Exacerbation in Preschool Children With Recurrent Wheezing. J Allergy Clin Immunol Pract. 2023 May;11(5):1485-1493.e8. doi: 10.1016/j.jaip.2023.01.037. Epub 2023 Feb 3.
Derived from this study: PubMed 26575060Bacharier LB, Guilbert TW, Mauger DT, Boehmer S, Beigelman A, Fitzpatrick AM, Jackson DJ, Baxi SN, Benson M, Burnham CD, Cabana M, Castro M, Chmiel JF, Covar R, Daines M, Gaffin JM, Gentile DA, Holguin F, Israel E, Kelly HW, Lazarus SC, Lemanske RF Jr, Ly N, Meade K, Morgan W, Moy J, Olin T, Peters SP, Phipatanakul W, Pongracic JA, Raissy HH, Ross K, Sheehan WJ, Sorkness C, Szefler SJ, Teague WG, Thyne S, Martinez FD. Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in Preschool Children With a History of Such Illnesses: A Randomized Clinical Trial. JAMA. 2015 Nov 17;314(19):2034-2044. doi: 10.1001/jama.2015.13896.

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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.

William B Busse, MD study chair

University of Wisconsin, Madison

Leonard B Bacharier, MD principal investigator

Washington University School of Medicine

Fernando D Martinez, MD principal investigator

University of Arizona

16 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 Azithromycin and Prednisolone in people with Asthma and Wheezing, run by Milton S. Hershey Medical Center at 16 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 8 inclusion and 24 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 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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. 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?

Yes. Results are posted in the registry (first posted 28 Dec 2016). 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?

Progression to Clinically Significant Lower Respiratory Tract Symptoms (time frame: 14 days after initiation of APRIL therapy). The study lists 2 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 NCT01272635, which also lists 2 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 28 Dec 2016.