Cystic FibrosisPhase 4TEACHNCT02677701
Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)
A Phase 4 study testing azithromycin and inhaled tobramycin in people with Cystic Fibrosis, run by Seattle Children's Hospital at 39 sites in United States.
Trial summary
This is a study to examine the effect of combining chronic oral azithromycin with inhaled tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected with P. aeruginosa. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- azithromycin and inhaled tobramycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 39 sitesUnited States
- Study dates
- 21 Oct 2016to 13 Feb 2020
- Phase
- Phase 4
- 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
- 12 years old or older
- documented diagnosis of cystic fibrosis
- written informed consent (and assent when applicable)
- at least two respiratory cultures growing P. aeruginosa within the last 12 months
- FEV1% predicted between 25-100%
- use of at least two cycles of inhaled tobramycin within the last 24 weeks
Show all 10Show fewer
- Off TISP and other inhaled anti-pseudomonal antibiotics for at least 2 weeks at Visit 1 and remain off of any inhaled antibiotics for an additional 2 weeks before starting inhaled tobramycin
- most recent liver function test results less than 4 times the upper limit of normal, obtained within the last 12 months
- prior or current use of azithromycin for at least four consecutive weeks
- stable clinical status and therapeutic regimen
Who cannot join
- weight <40 kg
- positive pregnancy test, lactating, or unwillingness to practice a pre-defined form of contraception, which includes abstinence
- inability to perform reproducible spirometry
- inability or unwillingness to cycle off of inhaled tobramycin for one 4-week period and without use of any additional inhaled antibiotics
- respiratory culture with Burkholderia cepacia complex species within 24 months or with nontuberculous mycobacteria within 18 months of screening
- use of intravenous or oral anti-pseudomonal antibiotics within 4 weeks of screening
Show all 12Show fewer
- use of investigational therapy within 4 weeks of screening
- use of systemic corticosteroids equivalent to a daily dose more than 10mg of prednisone
- use of nelfinavir, warfarin, haloperidol, or methadone (concern of drug interaction with azithromycin)
- initiation of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy within 30 days
- ECG abnormality at screening requiring prompt further medical attention, or QTc interval >480 msec for males and >486 msec for females
- any other condition that, in the opinion of the site investigator, would compromise the safety of the subject or quality of the data
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21287
Saint Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, 83712
Boston Children's Hospital
Boston, Massachusetts, 02115
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60208
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Dayton Children's Hospital
Dayton, Ohio, 45404
National Jewish Health
Denver, Colorado, 80206
Cook Children's Medical Center
Fort Worth, Texas, 76104
University of Florida
Gainesville, Florida, 32610
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, 17033
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Monmouth Medical Center
Long Branch, New Jersey, 07740
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55455
Yale University School of Medicine
New Haven, Connecticut, 06520
Beth Israel Medical Center
New York, New York, 10003
Children's Hospital of New York
New York, New York, 10032
The Nemours Children's Clinic - Orlando
Orlando, Florida, 32806
Stanford University Medical Center
Palo Alto, California, 94025
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Saint Francis Medical Center
Peoria, Illinois, 61637
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Maine Medical Partners Pediatric Specialty Care
Portland, Maine, 04102
Oregon Health Sciences University
Portland, Oregon, 97239
University of Rochester Medical Center Strong Memorial
Rochester, New York, 14642
Intermountain Cystic Fibrosis Center
Salt Lake City, Utah, 84113
Rady Children's Hospital and Health Center at the University of California San Diego
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98145
University of Washington Medical Center
Seattle, Washington, 98195
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104
St. Louis Children's Hospital
St Louis, Missouri, 63110
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01655
About this study
Official title: TEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A Randomized, Placebo-controlled, Double-blinded Trial of Azithromycin 500mg Thrice Weekly in Combination With Inhaled Tobramycin
This is a study to examine the effect of combining chronic oral azithromycin with inhaled tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected with P. aeruginosa.
Read the detailed description
This study is a prospective, randomized, double-blinded, placebo-controlled trial of azithromycin 500mg taken orally thrice weekly vs. placebo in subjects with cystic fibrosis and chronic airway infection with P. aeruginosa who are utilizing chronic inhaled tobramycin therapy. It will include approximately 120 subjects able to complete a primary 6-week study phase. Subjects will be at least 12 years old with a baseline forced expiratory volume at one second (FEV1) between 25-100% predicted. Subjects will continue to use clinically prescribed inhaled tobramycin cycled on/off every 4 weeks. They will be provided over-encapsulated azithromycin 500mg tablets or placebo during the primary study phase. An optional extension phase will be offered to all subjects completing the primary 6-week study. This 8-week extension phase will include an initial 4 weeks without use of inhaled tobramycin or other inhaled antibiotics, followed by a 4-week period with inhaled tobramycin use. All subjects participating in the extension phase of the study will be provided azithromycin 500mg tablets to be taken thrice weekly for the entire 8-week period.
This study will investigate how use of chronic oral azithromycin affects some of the previously demonstrated benefits to health when using inhaled tobramycin. The primary measurements will focus on lung function. Additional measurements will focus on disease-related quality of life as reported by subjects in the trial. Exploratory outcomes, including measurements of safety, are also planned.
- Conditions
- Cystic Fibrosis
- Being tested
- azithromycin, placebo (for azithromycin), inhaled tobramycin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycinDrug
Also called Zithromax
500mg tablet over-encapsulated to match placebo
placebo (for azithromycin)Drug
inhaled tobramycinDrug
clinically prescribed inhaled tobramycin used by subjects participating in the study
| Study group | Role | What they receive |
|---|---|---|
| azithromycin | Active comparator | azithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks Receives: Drug: azithromycin; Drug: inhaled tobramycin |
| placebo | Placebo comparator | encapsulated placebo taken by mouth thrice weekly for 6 weeks Receives: Drug: placebo (for azithromycin); Drug: inhaled tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change in Lung Function
Relative change in FEV1 volume (L) from enrollment at week 0 to the end of the 4-week period with inhaled tobramycin at week 6
Measured: baseline (week 0) to week 6 (6 week period)
Secondary outcomes (3)
Relative Change in Lung Function
Relative change in FEV1 (L) from the beginning of the 4-week period with inhaled tobramycin at week 2 to the end of the 4-week period with inhaled tobramycin at week 6
Measured: week 2 to week 6 (4 week period)
Change in Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)
Absolute change in CFRSD-CRISS from enrollment at week 0 to the end of the 4-week period with inhaled tobramycin at week 6. The Cystic Fibrosis Respiratory Symptoms Diary asks a participant to state the extent of 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest, and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present "a great deal" or "extremely." A summed score (ranging from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where lower scores indicate improvement of symptoms.
Measured: baseline (week 0) to week 6 (6 week period)
Change in Cystic Fibrosis Questionnaire - Revised Respiratory Symptom Score (CFQ-R RSS)
Absolute change in the CFQ-R RSS from enrollment at week 0 to the end of the 4-week period with inhaled tobramycin at week 6. Age appropriate versions of Cystic Fibrosis Questionnaire - Revised ask a participant from 4 to 6 questions related to respiratory symptoms. The Respiratory Domain Scaled Score is calculated as follows: 100*[sum of {responses-1}] / [{number of responses}*3] only if [number of responses] ≥ [number of possible responses]/2; otherwise the score is set to missing. The scaled score ranges from 0 to 100 and higher scores indicate improvement of symptoms.
Measured: baseline (week 0) to week 6 (6 week period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start21 Oct 2016
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
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.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cystic Fibrosis Foundation, CF Therapeutics Development Network Coordinating Center
- Responsible party
- Principal investigator, David Nichols, MD, Seattle Children's Hospital
- Investigators
- David P Nichols, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677701
- Sponsor's protocol ID
- TEACH-IP-15
- Other IDs
- 1R01HL124053-01A1, NICHOL15A0
- Acronym
- TEACH
- Status last verified
- Jun 2021
- First submitted
- 29 Jan 2016
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A Randomized, Placebo-controlled, Double-blinded Trial of Azithromycin 500mg Thrice Weekly in Combination With Inhaled Tobramycin
- ClinicalTrials.gov ID
- NCT02677701
- Acronym / sponsor ID
- TEACH / TEACH-IP-15
- Conditions
- Cystic Fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cystic Fibrosis Foundation, CF Therapeutics Development Network Coordinating Center
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 1 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to examine the effect of combining chronic oral azithromycin with inhaled tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected with P. aeruginosa.
Detailed description
This study is a prospective, randomized, double-blinded, placebo-controlled trial of azithromycin 500mg taken orally thrice weekly vs. placebo in subjects with cystic fibrosis and chronic airway infection with P. aeruginosa who are utilizing chronic inhaled tobramycin therapy. It will include approximately 120 subjects able to complete a primary 6-week study phase. Subjects will be at least 12 years old with a baseline forced expiratory volume at one second (FEV1) between 25-100% predicted. Subjects will continue to use clinically prescribed inhaled tobramycin cycled on/off every 4 weeks. They will be provided over-encapsulated azithromycin 500mg tablets or placebo during the primary study phase. An optional extension phase will be offered to all subjects completing the primary 6-week study. This 8-week extension phase will include an initial 4 weeks without use of inhaled tobramycin or other inhaled antibiotics, followed by a 4-week period with inhaled tobramycin use. All subjects participating in the extension phase of the study will be provided azithromycin 500mg tablets to be taken thrice weekly for the entire 8-week period.
This study will investigate how use of chronic oral azithromycin affects some of the previously demonstrated benefits to health when using inhaled tobramycin. The primary measurements will focus on lung function. Additional measurements will focus on disease-related quality of life as reported by subjects in the trial. Exploratory outcomes, including measurements of safety, are also planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azithromycin | Active comparator | Drug: azithromycin, Drug: inhaled tobramycinazithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks |
| placebo | Placebo comparator | Drug: placebo (for azithromycin), Drug: inhaled tobramycinencapsulated placebo taken by mouth thrice weekly for 6 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 12 years old or older
- documented diagnosis of cystic fibrosis
- written informed consent (and assent when applicable)
- at least two respiratory cultures growing P. aeruginosa within the last 12 months
- FEV1% predicted between 25-100%
Key exclusion criteria (12 listed)
- weight <40 kg
- positive pregnancy test, lactating, or unwillingness to practice a pre-defined form of contraception, which includes abstinence
- inability to perform reproducible spirometry
- inability or unwillingness to cycle off of inhaled tobramycin for one 4-week period and without use of any additional inhaled antibiotics
- respiratory culture with Burkholderia cepacia complex species within 24 months or with nontuberculous mycobacteria within 18 months of screening
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 |
|---|---|---|
| azithromycinAlso: Zithromax500mg tablet over-encapsulated to match placebo | Drug | azithromycin |
| placebo (for azithromycin) | Drug | placebo |
| inhaled tobramycinclinically prescribed inhaled tobramycin used by subjects participating in the study | Drug | azithromycin, placebo |
Primary outcome
Relative Change in Lung Function
Time frame: baseline (week 0) to week 6 (6 week period)
Relative change in FEV1 volume (L) from enrollment at week 0 to the end of the 4-week period with inhaled tobramycin at week 6
3 secondary outcomes
Relative Change in Lung Function
Time frame: week 2 to week 6 (4 week period)
Change in Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)
Time frame: baseline (week 0) to week 6 (6 week period)
Change in Cystic Fibrosis Questionnaire - Revised Respiratory Symptom Score (CFQ-R RSS)
Time frame: baseline (week 0) to week 6 (6 week period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David P Nichols, MD principal investigator
National Jewish Health
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing azithromycin and inhaled tobramycin in people with Cystic Fibrosis, run by Seattle Children's Hospital at 39 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 10 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 28 Jun 2021. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 1 Mar 2021). 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?
Relative Change in Lung Function (time frame: baseline (week 0) to week 6 (6 week period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2021.