Cystic FibrosisPhase 3OPTIMIZENCT02054156

OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis

A Phase 3 study testing azithromycin and Tobramycin solution for inhalation in people with Cystic Fibrosis, run by Bonnie Ramsey at 45 sites in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 6 months to 18 years
Conditions the study is for: Cystic Fibrosis
What is being tested?: azithromycin and Tobramycin solution for inhalation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 221 participants
Where: 45 sitesUnited States
Study dates: Jun 2014to 23 Aug 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 6 months to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age ≥ 6 months to ≤ 18 years
Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype or positive CF Newborn Screening result for immunoreactive trypsinogen (IRT) IRT/DNA or IRT/IRT and one or more of the following criteria:
sweat chloride ≥ 60 milliequivalent (mEq)/liter by quantitative by pilocarpine iontophoresis test (QPIT)
two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than - 5 mV)
Documented new positive oropharyngeal, sputum or lower respiratory tract culture for Pa within 30 days of the Baseline Visit (Visit 1), defined as: a) first lifetime documented Pa positive culture; or b) Pa recovered after at least a two-year history of Pa negative respiratory cultures (≥ 1 culture/ year)
Clinically stable with no evidence of any significant respiratory symptoms at the Baseline Visit that would require administration of intravenous anti- pseudomonal antibiotics, oxygen supplementation, and/or hospitalization as determined by the study physician
Written informed consent obtained from participant or participant's legal representative (and assent when applicable) and ability for participant to comply with the requirements of the study

Who cannot join

Macrolide antibiotic use within 30 days of the Baseline Visit
Initiation of current course of treatment with TIS >14 days prior to Baseline Visit
Weight <6.0 kg at the Baseline Visit
History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside
History of azithromycin hypersensitivity or adverse reaction to azithromycin or allergy to macrolide antibiotics
History of positive respiratory culture for Non-tuberculous mycobacteria (NTM) or Burkholderia cepacia complex within 2 years of the Baseline Visit

Show all 15Show fewer

History of unresolved, abnormal renal function (defined as serum creatinine greater than 1.5 times the upper limit of normal for age).
History of unresolved, abnormal liver function tests (defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 4 times the upper limit of normal range) or history of portal hypertension
History of unresolved, abnormal neutropenia (ANC ≤ 1000)
Abnormal ECG test at the Baseline Visit defined as a QT interval corrected (QTc) (B) of ≥460 msec or history of ventricular arrhythmia
History of abnormal hearing sensitivity defined as hearing threshold levels >25 dB HL (decibels Hearing Level) for visual reinforcement audiometry (VRA) at any frequency (500-4000Hz) or >20 Decibels Hearing Level (dBHL) for play or standard audiometry at any two frequencies (500-8000Hz) in either ear, not associated with middle ear disease (including infection) or a flat (Type B) tympanogram
New initiation of chronic therapy (greater than 21 days) with drugs known to prolong QT interval (refer to Appendix III) within 30 days prior to the Baseline Visit or coadministration of nelfinavir or oral anticoagulants
Positive serum or urine pregnancy test at the Baseline Visit (to be performed on all females of child-bearing potential) or for females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception during participation in the study
Administration of any investigational drug within 30 days prior to the Baseline Visit
Presence of a condition or abnormality (e.g., pre-existing heart disease) that in the opinion of the site investigator would compromise the safety of the participant or the quality of the data

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

United States45 sites

CFF Care Center & Pediatric Program Akron Children's Hospital
Akron, Ohio, 44308
CFF Affiliate Program Providence Medical Center
Anchorage, Alaska, 99519-6604
CFF Care Center & Pediatric Program University of Michigan
Ann Arbor, Michigan, 48109-5212
CFF Care Center & Pediatric Program Emory University
Atlanta, Georgia, 30324
CFF Affiliate Program Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
CFF Care Center & Pediatric Program Children's Hospital Colorado
Aurora, Colorado, 80045
CFF Care Center & Pediatric Program Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
CFF Care Center St. Luke's CF Clinic
Boise, Idaho, 83712
CFF Care Center & Pediatric Program Children's Hospital Boston
Boston, Massachusetts, 02115
CFF Care Center & Pediatric Program University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
CFF Care Center & Pediatric Program Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2605
CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
CFF Care Center & Pediatric Program Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
CFF Care Center & Pediatric Program Nationwide Children's Hospital
Columbus, Ohio, 43205
CFF Care Center & Pediatric Program The Children's Medical Center
Dayton, Ohio, 45404
CFF Care Center & Pediatric Program Children's Hospital of Michigan
Detroit, Michigan, 48201
CFF Care Center & Pediatric Program Hershey Medical Center
Hershey, Pennsylvania, 17033
CFF Care Center & Pediatric Program Riley Hospital for Children
Indianapolis, Indiana, 46202-5271
CFF Care Center & Pediatric Program University of Iowa
Iowa City, Iowa, 52242
CFF Care Center & Pediatric Program Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, 32207
CFF Care Center The Children's Mercy Hospital
Kansas City, Missouri, 64108
CFF Care Center & Pediatric Program Arkansas Children's Hospital
Little Rock, Arkansas, 72202
CFF Care Center & Pediatric Program Monmouth Medical Center
Long Branch, New Jersey, 07740
Childrens Hospital Los Angeles
Los Angeles, California, 90027
CFF Care Center & Pediatric Program University of Wisconsin
Madison, Wisconsin, 53792
CFF Care Center & Pediatric Program University of Tennessee
Memphis, Tennessee, 38103
CFF Care Center & Pediatric Program Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
CFF Care Center & Pediatric Program Yale University
New Haven, Connecticut, 06520
CFF Care Center & Pediatric Program Columbia University
New York, New York, 10032
CFF Care Center & Pediatric Program Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
CFF Care Center & Pediatric Program University of Nebraska Medical Center
Omaha, Nebraska, 68198
CFF Care Center & Pediatric Program Stanford University
Palo Alto, California, 94304
CFF Care Center & Pediatric Program Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
CFF Care Center & Pediatric Program Maine Medical Center
Portland, Maine, 04102
CFF Care Center & Pediatric Program Oregon Health & Sciences University
Portland, Oregon, 97239
CFF Care Center Medical College of Virginia
Richmond, Virginia, 23298
University of Utah
Salt Lake City, Utah, 84132
CFF Care Center & Pediatric Program Seattle Children's Hospital
Seattle, Washington, 98145
CFF Care Center & Pediatric Program Sanford USD Medical Center
Sioux Falls, South Dakota, 57117
CFF Care Center & Pediatric Program Cardinal Glennon Children's Hospital/Saint Louis University
St Louis, Missouri, 63104
CFF Care Center & Pediatric Program St. Louis Children's Hospital
St Louis, Missouri, 63110
CFF Care Center & Pediatric Program All Children's Hospital
St. Petersburg, Florida, 33701
CFF Care Center & Pediatric Program SUNY Upstate Medical University
Syracuse, New York, 13210
CFF Care Center Arizona Health Science Center
Tucson, Arizona, 85724
CFF Care Center New York Medical College
Valhalla, New York, 10595

Other trials in United States

About this study

Official title: OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial

The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.

Read the detailed description

Cystic fibrosis (CF) lung disease begins in the first few months of life and follows a course of recurrent lower airway bacterial infection and inflammation and progression of disease over years and decades at a variable pace. With the development of chronic lung infection, obstructive disease progressively worsens, ultimately leading to respiratory failure. Pseudomonas aeruginosa (Pa) is the most important pathogen infecting the CF lower airways, and its acquisition early in life is associated with a pro-inflammatory effect, lower lung function, poor nutritional outcomes, and decreased survival.

Pseudomonas aeruginosa (Pa) infection of the cystic fibrosis (CF) airway typically proceeds from early infection to chronic infection. Although some studies have shown that a minority of individuals with CF spontaneously clear early Pseudomonas aeruginosa (Pa) infection, data from multiple studies suggest that antibiotics are superior to no treatment in clearing Pseudomonas aeruginosa (Pa) from respiratory cultures. Understanding the transition period from early to chronic Pseudomonas aeruginosa (Pa) infection is thus of critical importance in identifying strategies to prevent this progression.

The study will assess the clinical and microbiologic efficacy and safety of azithromycin given three times weekly in combination with standardized tobramycin solution for inhalation (TIS) therapy among children with early Pseudomonas aeruginosa (Pa). TIS therapy is defined as an initial eradication treatment with 1-2 courses of 28 days TIS and subsequent 28 day treatments only at times a quarterly respiratory culture is positive for Pseudomonas aeruginosa (Pa). Eligible participants will be randomized within one month of their Pseudomonas aeruginosa (Pa) positive culture to receive one of the following two treatment strategies for 18 months: (1) oral placebo in addition to standardized TIS therapy, or (2) oral azithromycin in addition to standardized TIS therapy.

At the first study visit, participants will undergo a physical examination and a review of their medical history. Lung function will be measured via spirometry (in children greater than four years of age who are able to perform spirometry), electrocardiogram (ECG) testing will be conducted, and hearing ability will be measured via audiometry. Blood will be drawn for laboratory tests and a specimen will be obtained for a respiratory culture before randomization and study drug dispensing occurs. Subsequent study visits will take place at Day 21, Weeks 13, 26, 39, 52, 65, and 78. At each visit, participants will undergo a physical examination, a spirometry test (as appropriate), a respiratory specimen for Pseudomonas aeruginosa (Pa) culture will be collected and study drug will be dispensed (except at Week 78). Participants will complete self-report or parent-completed respiratory symptom questionnaires and signs and symptoms evaluations will be performed at all visits. Repeat hearing and laboratory tests will be performed at Weeks 39 and 78 and ECG testing will be repeated at Day 21 and Week 78. Participants will be required to maintain a medication diary throughout the study.

Conditions: Cystic Fibrosis
Being tested: azithromycin, placebo, Tobramycin solution for inhalation
Keywords: Cystic fibrosis (CF), Azithromycin, Tobramycin solution for inhalation (TIS), Pseudomonas aeruginosa (Pa), Early Pseudomonas aeruginosa infection, Pulmonary exacerbation, Standardized anti-pseudomonal therapy
Medical subject headings: Cystic Fibrosis, Pseudomonas Infections

What participants receive

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

azithromycinDrug
3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
placeboDrug
3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
Tobramycin solution for inhalationDrug
Also called TIS
300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months

Study groups in NCT02054156
Study group	Role	What they receive
azithromycin and TIS	Active comparator	azithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months Receives: Drug: azithromycin; Drug: Tobramycin solution for inhalation
placebo and TIS	Placebo comparator	placebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months Receives: Drug: placebo; Drug: Tobramycin solution for inhalation

What is being measured

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

Time to a Protocol-defined Pulmonary Exacerbation
Time to a protocol-defined pulmonary exacerbation requiring oral, inhaled, or intravenous antibiotics, using a prespecified definition available in the study protocol.
Measured: Over the 18-month study period

Secondary outcomes (3)

Time to Pseudomonas Aeruginosa (Pa) Recurrence
Time to Pseudomonas aeruginosa (Pa) recurrence after the first quarter of treatment
Measured: Over the 18-month study period
Adverse Events (AEs) and Serious Adverse Events (SAEs)
The number and percentage of participants with at least one event over the 18-month study period.
Measured: Over the 18-month study period
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Rate is defined as the number of events per participant follow-up month.
Measured: Over the 18-month study period

Timeline

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

Jun 201423 Aug 2018

First posted4 Feb 2014 (estimated)
Study startJun 2014
Primary completion23 Aug 2018
Study completion23 Aug 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 (1)Papers the sponsor has linked to this study.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02054156
Sponsor's protocol ID: OPTIMIZE-IP-12
Other IDs: 1U01HL114623-01A1, 1U01HL114589-01A1
Acronym: OPTIMIZE
Status last verified: Sep 2019
First submitted: 1 Feb 2014
Last updated: 1 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Mayer-Hamblett N, Retsch-Bogart G, Kloster M, Accurso F, Rosenfeld M, Albers G, Black P, Brown P, Cairns A, Davis SD, Graff GR, Kerby GS, Orenstein D, Buckingham R, Ramsey BW; OPTIMIZE Study Group. Azithromycin for Early Pseudomonas Infection in Cystic Fibrosis. The OPTIMIZE Randomized Trial. Am J Respir Crit Care Med. 2018 Nov 1;198(9):1177-1187. doi: 10.1164/rccm.201802-0215OC.
PubMed 29890086

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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All Cystic Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial
ClinicalTrials.gov ID: NCT02054156
Acronym / sponsor ID: OPTIMIZE / OPTIMIZE-IP-12
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis (CF), Azithromycin, Tobramycin solution for inhalation (TIS), Pseudomonas aeruginosa (Pa), Early Pseudomonas aeruginosa infection, Pulmonary exacerbation, Standardized anti-pseudomonal therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: Bonnie RamseyUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jun 2014
Primary completion: 23 Aug 2018 (actual)
Study completion: 23 Aug 2018 (actual)
First posted: 4 Feb 2014 (estimated)
Results: Posted 1 Oct 2019

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: 2

Arm	Type	Receives
azithromycin and TIS	Active comparator	Drug: azithromycin, Drug: Tobramycin solution for inhalationazithromycin and tobramycin solution for inhalation (TIS) Azithromycin 3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
placebo and TIS	Placebo comparator	Drug: placebo, Drug: Tobramycin solution for inhalationplacebo and tobramycin solution for inhalation (TIS) Placebo 3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months Tobramycin solution for inhalation (TIS), 300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months

Who may qualify

Ages: 6 months to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

Age ≥ 6 months to ≤ 18 years
Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype or positive CF Newborn Screening result for immunoreactive trypsinogen (IRT) IRT/DNA or IRT/IRT and one or more of the following criteria:
sweat chloride ≥ 60 milliequivalent (mEq)/liter by quantitative by pilocarpine iontophoresis test (QPIT)
two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than - 5 mV)

Key exclusion criteria (15 listed)

Macrolide antibiotic use within 30 days of the Baseline Visit
Initiation of current course of treatment with TIS >14 days prior to Baseline Visit
Weight <6.0 kg at the Baseline Visit
History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside
History of azithromycin hypersensitivity or adverse reaction to azithromycin or allergy to macrolide antibiotics

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
azithromycin3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months	Drug	azithromycin and TIS
placebo3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months	Drug	placebo and TIS
Tobramycin solution for inhalationAlso: TIS300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months	Drug	azithromycin and TIS, placebo and TIS

Primary outcome

Time to a Protocol-defined Pulmonary Exacerbation
Time frame: Over the 18-month study period
Time to a protocol-defined pulmonary exacerbation requiring oral, inhaled, or intravenous antibiotics, using a prespecified definition available in the study protocol.

3 secondary outcomes

Time to Pseudomonas Aeruginosa (Pa) Recurrence
Time frame: Over the 18-month study period
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Over the 18-month study period
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Over the 18-month study period

Results and safety

Results posted to the registry on 1 Oct 2019, 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	110	35
Placebo	111	30

Primary outcome: Time to a Protocol-defined Pulmonary Exacerbation

Time frame: Over the 18-month study period. Median (95% Confidence Interval). Unit: years

Measure	Azithromycin n = 110	Placebo n = 111
Value	1.350 (0.898 to NA)	0.758 (0.572 to 0.969)

Azithromycin vs Placebo: Hazard Ratio (HR): 0.56 (95% CI 0.37 to 0.83), p = 0.0043, Cox Proportional Hazards Model

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azithromycin	25 of 110 (22.7%)	99 of 110 (90%)	0 of 110
Placebo	28 of 111 (25.2%)	92 of 111 (82.9%)	0 of 111

Limitations and caveats (from the sponsor): A DSMB monitored the trial using pre-specified stopping guidelines for efficacy and safety. At the 4th analysis the efficacy bound was crossed. The DSMB determined the study met it's aim and recommended closing the study to enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29890086Mayer-Hamblett N, Retsch-Bogart G, Kloster M, Accurso F, Rosenfeld M, Albers G, Black P, Brown P, Cairns A, Davis SD, Graff GR, Kerby GS, Orenstein D, Buckingham R, Ramsey BW; OPTIMIZE Study Group. Azithromycin for Early Pseudomonas Infection in Cystic Fibrosis. The OPTIMIZE Randomized Trial. Am J Respir Crit Care Med. 2018 Nov 1;198(9):1177-1187. doi: 10.1164/rccm.201802-0215OC.

Related trials for Cystic Fibrosis

RecruitingPhase 2
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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.

Bonnie Ramsey, MD principal investigator

Seattle Children's Center for Clinical and Translational Research, CF Therapeutics Development Network Clinical Coordinating Center

Nicole Hamblett, PhD principal investigator

Seattle Children's Core for Biomedical Statistics

45 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 Tobramycin solution for inhalation in people with Cystic Fibrosis, run by Bonnie Ramsey at 45 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 15 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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 1 Oct 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?

Time to a Protocol-defined Pulmonary Exacerbation (time frame: Over the 18-month study 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 NCT02054156, which also lists 1 linked publication.

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 1 Oct 2019.