Cystic FibrosisPhase 3COMBATCFNCT01270074
Prevention of Bronchiectasis in Infants With Cystic Fibrosis
A Phase 3 study testing Azithromycin in people with Cystic Fibrosis and Bronchiectasis, run by The University of Queensland at 10 sites in 2 countries.
Trial summary
The general aim of this project is to conduct a randomized, double-blind, placebo-controlled clinical trial of azithromycin to determine whether treatment from infancy is safe and will prevent the onset of bronchiectasis. Read more about this study
- Who is it for?
- Ages 6 weeks to 6 months
- Conditions the study is for
- Cystic Fibrosis, Bronchiectasis
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Apr 2012to Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either sex with a diagnosis of CF following detection via New Born Screening (NBS) for cystic fibrosis
- Participants who, in the opinion of the Investigator, are able to comply with the protocol for its duration
- Written informed consent signed and dated by parent/legal guardian according to local regulations
Who cannot join
- Born <30 weeks gestation
- Prolonged mechanical ventilation in the first 3 months of life
- Participation in another randomized controlled trial within the 3 months preceding inclusion in this study
- A significant medical disease or condition other than CF that is likely to interfere with the child's ability to complete the entire protocol
- Previous major surgery except for meconium ileus
- Macrolide hypersensitivity
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Australia9 sites
Women's and Children's Hospital
Adelaide, South Australia
Queensland Children's Hospital
Brisbane, Queensland, 4101
Mater Children's Hospital
Brisbane, Queensland
Royal Children's Hospital
Brisbane, Queensland
Monash Medical Centre
Melbourne, Victoria
Royal Children's Hospital
Melbourne, Victoria
Perth Children's Hospital
Perth, Western Australia, 6009
Sydney Children's Hospital
Sydney, New South Wales
Westmead Children's Hospital
Sydney, New South Wales
About this study
Official title: A Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis.
The general aim of this project is to conduct a randomized, double-blind, placebo-controlled clinical trial of azithromycin to determine whether treatment from infancy is safe and will prevent the onset of bronchiectasis. One hundred and thirty infants will be recruited from CF clinics in Australia and New Zealand and treated from 3 months to three years of age. The primary outcome will be the proportion with radiologically-defined bronchiectasis at 3 years of age. Safety and mechanistic evaluations will also be undertaken.
Read the detailed description
SYNOPSIS OF PROTOCOL
Title Multi-centre randomized placebo-controlled study of azithromycin in the primary prevention of radiologically-defined bronchiectasis in infants with Cystic Fibrosis
Clinical Phase Phase 3
Protocol Number: AZI001
TGA Reference Number:
Protocol Co-Chairs: Peter D. Sly \& Stephen M. Stick Microbiology Consultant: Lisa Saiman CT Consultant: Harm Tiddens Statistical Consultant: Robert S Ware
Study Design Randomized, double-blind parallel groups. Participants will be randomized into one of the following 2 groups on a 1:1 ratio with 65 participants per group;
Group A: 10 mg/kg (as 200mg/5ml) azithromycin three times weekly for three years added to standard CF therapy.
Group B: matched placebo three times weekly for three years added to standard CF therapy.
Accrual Objective 130 children
Accrual Period 24 months
Study Duration 36 months
Countries: Australia and New Zealand
Sites: Brisbane Au, Sydney, Au, Melbourne Au, Adelaide Au, Perth Au,Auckland Nz, Christchurch Nz.
Primary Endpoint The primary endpoints are the proportion of children with radiologically-defined bronchiectasis at age 3 years, and the proportion of lung tissue affected by disease at age 3 years.
Secondary Endpoints
- The extent and severity of bronchiectasis at age 3 years
- The volume of trapped gas at age 3 years
- CF-related quality of life
- Time to first pulmonary exacerbation
- Proportion of participants experiencing a pulmonary exacerbation
- Number of courses of inhaled or oral antibiotics
- Number of days of inhaled antibiotics
- Incidence of hospitalizations/Accident and Emergency department (A\&E) visits for an acute respiratory exacerbation
- Number of days hospitalized for an acute respiratory exacerbation
- Number of days if intravenous antibiotics
- Body mass index at 3 years of age.
Exploratory Endpoints
- Markers of neutrophilic inflammation
- Markers of oxidative stress
- Composition of airway flora
Safety Endpoints
- Proportion of participants growing P. aeruginosa in BAL
- Age of acquisition of P. aeruginosa in BAL
- Emergence of macrolide-resistant S. aureus, small colony variant S. aureus and non-tuberculous mycobacteria (NTM)
- Treatment-related adverse events
- Haematology and clinical chemistry
Inclusion Criteria Participants who meet all of the following criteria are eligible for enrolment as study participants:
- Children of either sex with a diagnosis of CF following detection via New Born Screening (NBS) for cystic fibrosis
- Participants who, in the opinion of the Investigator, are able to comply with the protocol for its duration
- Written informed consent signed and dated by parent/legal guardian according to local regulations
Exclusion Criteria Participants who meet any of these criteria are not eligible for enrolment as trial participants:
- Born <30 weeks gestation
- Prolonged mechanical ventilation in the first 3 months of life
- Participation in another randomized controlled trial within the 3 months preceding inclusion in this study
- A significant medical disease or condition other than CF that is likely to interfere with the child's ability to complete the entire protocol
- Previous major surgery except for meconium ileus
- Macrolide hypersensitivity
Treatment Description ZITHROMAX® (azithromycin)
Study Procedures The study participants will be stratified by investigational site and randomly assigned to either azithromycin or placebo for three years.
Statistical Considerations Participants will be randomized in blocks to the treatment group or the placebo group using a one-to-one ratio. Randomization will be stratified by study site. This will ensure an approximately equal allocation to each group within each site.
Interim Analyses Interim analyses will occur when the first 50% of children (n=33 per group have completed the 12 month CT and when all subjects have completed the 12 month CT. Interim analyses will determine safety or success (unethical to continue).
Stopping Rules Study enrolment may be stopped if any of the following events occur:
- Death of a participant that is related to study treatment.
- The trial meets the definition of futility or success at either of the planned interim analyses
- Conditions
- Cystic Fibrosis, Bronchiectasis
- Being tested
- Azithromycin, Placebo control
- Keywords
- double blind placebo controlled randomised clinical trial, azithromycin, infant, pediatric, cystic fibrosis, bronchiectasis
- Medical subject headings
- Cystic Fibrosis, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
azithromycin will be given as a liquid preparation at a dose of 10 mg/kg three times per week from three months of age until three years of age
Placebo controlDrug
inert liquid preparation will be given three times per week from three months of age to three years of age
| Study group | Role | What they receive |
|---|---|---|
| azithromycin liquid preparation | Experimental | azithromycin will be given at a dose of 10mg/kg given three times per week from three months of age to three years of age Receives: Drug: Azithromycin |
| inert liquid preparation | Active comparator | inert liquid preparation will be given three times per week from three months of age to three years of age Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with radiologically-defined bronchiectasis
bronchiectasis will be determined from a low dose volumetric chest computed tomography scan performed at 3 years of age
Measured: at three years of age
The proportion of lung tissue affected by disease
Percentage of diseased lung will be determined from a low dose volumetric chest computed tomography scan performed at 3 years of age
Measured: at three years of age
Secondary outcomes (9)
extent and severity of bronchiectasis
bronchiectasis will be determined from a low dose volumetric chest computed tomography scan performed at 3 years of age
Measured: at three years of age
CF-related quality of life
Quality of life questionnaire to be measured at 3 years
Measured: at three years of age
time to first pulmonary exacerbation
pulmonary exacerbation will be defined using a standardized instrument
Measured: over the first three years of life
proportion of participants experiencing a pulmonary exacerbation
pulmonary exacerbation will be defined using a standardized instrument
Measured: over the first three years of life
body mass index
body mass index will be calcualted from hieight and weight measurements taken at 3 years of age.
Measured: at three years of age
Proportion of participants growing Pseudomonas aeruginosa in bronchoalveolar lavage
bronchoalveolar lavage will be performed at 3 months, 1 year and 3 years of age
Measured: over the first three years of life
age of acquisition of Pseudomonas aeruginosa
Measured: over the first three years of life
Emergence of macrolide-resistant Staphylococcus aureus, small colony variant Staphylococcal aureus and non-tuberculous mycobacterium
Measured: over the first three years of life
Volume of trapped gas at age 3 years
air trapping will be determined from a low dose volumetric chest computed tomography scan performed at 3 years of age
Measured: at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startApr 2012
- Primary completionMar 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Telethon Kids Institute
- Responsible party
- Sponsor
- Investigators
- Peter D Sly, MMBS MD DSc, Study chair, The University of QueenslandStephen M Stick, MBBChir PhD, Study chair, Telethon Kids Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270074
- Sponsor's protocol ID
- AZI001
- Other IDs
- STICK10K0
- Acronym
- COMBATCF
- Status last verified
- Nov 2019
- First submitted
- 23 Dec 2010
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Douglas TA, Brennan S, Gard S, Berry L, Gangell C, Stick SM, Clements BS, Sly PD. Acquisition and eradication of P. aeruginosa in young children with cystic fibrosis. Eur Respir J. 2009 Feb;33(2):305-11. doi: 10.1183/09031936.00043108. Epub 2008 Nov 14.
PubMed 19010992Sly PD, Brennan S, Gangell C, de Klerk N, Murray C, Mott L, Stick SM, Robinson PJ, Robertson CF, Ranganathan SC; Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST-CF). Lung disease at diagnosis in infants with cystic fibrosis detected by newborn screening. Am J Respir Crit Care Med. 2009 Jul 15;180(2):146-52. doi: 10.1164/rccm.200901-0069OC. Epub 2009 Apr 16.
PubMed 19372250Stick SM, Brennan S, Murray C, Douglas T, von Ungern-Sternberg BS, Garratt LW, Gangell CL, De Klerk N, Linnane B, Ranganathan S, Robinson P, Robertson C, Sly PD; Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST CF). Bronchiectasis in infants and preschool children diagnosed with cystic fibrosis after newborn screening. J Pediatr. 2009 Nov;155(5):623-8.e1. doi: 10.1016/j.jpeds.2009.05.005. Epub 2009 Jul 19.
PubMed 19616787Stick SM, Foti A, Ware RS, Tiddens HAWM, Clements BS, Armstrong DS, Selvadurai H, Tai A, Cooper PJ, Byrnes CA, Belessis Y, Wainwright C, Jaffe A, Robinson P, Saiman L, Sly PD; COMBAT CF Study Group. The effect of azithromycin on structural lung disease in infants with cystic fibrosis (COMBAT CF): a phase 3, randomised, double-blind, placebo-controlled clinical trial. Lancet Respir Med. 2022 Aug;10(8):776-784. doi: 10.1016/S2213-2600(22)00165-5. Epub 2022 Jun 2.
PubMed 35662406
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT01270074
- Acronym / sponsor ID
- COMBATCF / AZI001
- Conditions
- Cystic Fibrosis, Bronchiectasis
- Keywords
- double blind placebo controlled randomised clinical trial, azithromycin, infant, pediatric, cystic fibrosis, bronchiectasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Telethon Kids Institute
- Study start
- Apr 2012 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general aim of this project is to conduct a randomized, double-blind, placebo-controlled clinical trial of azithromycin to determine whether treatment from infancy is safe and will prevent the onset of bronchiectasis. One hundred and thirty infants will be recruited from CF clinics in Australia and New Zealand and treated from 3 months to three years of age. The primary outcome will be the proportion with radiologically-defined bronchiectasis at 3 years of age. Safety and mechanistic evaluations will also be undertaken.
Detailed description
SYNOPSIS OF PROTOCOL
Title Multi-centre randomized placebo-controlled study of azithromycin in the primary prevention of radiologically-defined bronchiectasis in infants with Cystic Fibrosis
Clinical Phase Phase 3
Protocol Number: AZI001
TGA Reference Number:
Protocol Co-Chairs: Peter D. Sly \& Stephen M. Stick Microbiology Consultant: Lisa Saiman CT Consultant: Harm Tiddens Statistical Consultant: Robert S Ware
Study Design Randomized, double-blind parallel groups. Participants will be randomized into one of the following 2 groups on a 1:1 ratio with 65 participants per group;
Group A: 10 mg/kg (as 200mg/5ml) azithromycin three times weekly for three years added to standard CF therapy.
Group B: matched placebo three times weekly for three years added to standard CF therapy.
Accrual Objective 130 children
Accrual Period 24 months
Study Duration 36 months
Countries: Australia and New Zealand
Sites: Brisbane Au, Sydney, Au, Melbourne Au, Adelaide Au, Perth Au,Auckland Nz, Christchurch Nz.
Primary Endpoint The primary endpoints are the proportion of children with radiologically-defined bronchiectasis at age 3 years, and the proportion of lung tissue affected by disease at age 3 years.
Secondary Endpoints
- The extent and severity of bronchiectasis at age 3 years
- The volume of trapped gas at age 3 years
- CF-related quality of life
- Time to first pulmonary exacerbation
- Proportion of participants experiencing a pulmonary exacerbation
- Number of courses of inhaled or oral antibiotics
- Number of days of inhaled antibiotics
- Incidence of hospitalizations/Accident and Emergency department (A\&E) visits for an acute respiratory exacerbation
- Number of days hospitalized for an acute respiratory exacerbation
- Number of days if intravenous antibiotics
- Body mass index at 3 years of age.
Exploratory Endpoints
- Markers of neutrophilic inflammation
- Markers of oxidative stress
- Composition of airway flora
Safety Endpoints
- Proportion of participants growing P. aeruginosa in BAL
- Age of acquisition of P. aeruginosa in BAL
- Emergence of macrolide-resistant S. aureus, small colony variant S. aureus and non-tuberculous mycobacteria (NTM)
- Treatment-related adverse events
- Haematology and clinical chemistry
Inclusion Criteria Participants who meet all of the following criteria are eligible for enrolment as study participants:
- Children of either sex with a diagnosis of CF following detection via New Born Screening (NBS) for cystic fibrosis
- Participants who, in the opinion of the Investigator, are able to comply with the protocol for its duration
- Written informed consent signed and dated by parent/legal guardian according to local regulations
Exclusion Criteria Participants who meet any of these criteria are not eligible for enrolment as trial participants:
- Born <30 weeks gestation
- Prolonged mechanical ventilation in the first 3 months of life
- Participation in another randomized controlled trial within the 3 months preceding inclusion in this study
- A significant medical disease or condition other than CF that is likely to interfere with the child's ability to complete the entire protocol
- Previous major surgery except for meconium ileus
- Macrolide hypersensitivity
Treatment Description ZITHROMAX® (azithromycin)
Study Procedures The study participants will be stratified by investigational site and randomly assigned to either azithromycin or placebo for three years.
Statistical Considerations Participants will be randomized in blocks to the treatment group or the placebo group using a one-to-one ratio. Randomization will be stratified by study site. This will ensure an approximately equal allocation to each group within each site.
Interim Analyses Interim analyses will occur when the first 50% of children (n=33 per group have completed the 12 month CT and when all subjects have completed the 12 month CT. Interim analyses will determine safety or success (unethical to continue).
Stopping Rules Study enrolment may be stopped if any of the following events occur:
- Death of a participant that is related to study treatment.
- The trial meets the definition of futility or success at either of the planned interim analyses
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azithromycin liquid preparation | Experimental | Drug: Azithromycinazithromycin will be given at a dose of 10mg/kg given three times per week from three months of age to three years of age |
| inert liquid preparation | Active comparator | Drug: Placebo controlinert liquid preparation will be given three times per week from three months of age to three years of age |
Who may qualify
- Ages
- 6 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of either sex with a diagnosis of CF following detection via New Born Screening (NBS) for cystic fibrosis
- Participants who, in the opinion of the Investigator, are able to comply with the protocol for its duration
- Written informed consent signed and dated by parent/legal guardian according to local regulations
Key exclusion criteria (6 listed)
- Born <30 weeks gestation
- Prolonged mechanical ventilation in the first 3 months of life
- Participation in another randomized controlled trial within the 3 months preceding inclusion in this study
- A significant medical disease or condition other than CF that is likely to interfere with the child's ability to complete the entire protocol
- Previous major surgery except for meconium ileus
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: Zithromaxazithromycin will be given as a liquid preparation at a dose of 10 mg/kg three times per week from three months of age until three years of age | Drug | azithromycin liquid preparation |
| Placebo controlinert liquid preparation will be given three times per week from three months of age to three years of age | Drug | inert liquid preparation |
Primary outcome
Proportion of children with radiologically-defined bronchiectasis
Time frame: at three years of age
bronchiectasis will be determined from a low dose volumetric chest computed tomography scan performed at 3 years of age
The proportion of lung tissue affected by disease
Time frame: at three years of age
Percentage of diseased lung will be determined from a low dose volumetric chest computed tomography scan performed at 3 years of age
9 secondary outcomes
extent and severity of bronchiectasis
Time frame: at three years of age
CF-related quality of life
Time frame: at three years of age
time to first pulmonary exacerbation
Time frame: over the first three years of life
proportion of participants experiencing a pulmonary exacerbation
Time frame: over the first three years of life
body mass index
Time frame: at three years of age
Proportion of participants growing Pseudomonas aeruginosa in bronchoalveolar lavage
Time frame: over the first three years of life
age of acquisition of Pseudomonas aeruginosa
Time frame: over the first three years of life
Emergence of macrolide-resistant Staphylococcus aureus, small colony variant Staphylococcal aureus and non-tuberculous mycobacterium
Time frame: over the first three years of life
Volume of trapped gas at age 3 years
Time frame: at 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 19010992Douglas TA, Brennan S, Gard S, Berry L, Gangell C, Stick SM, Clements BS, Sly PD. Acquisition and eradication of P. aeruginosa in young children with cystic fibrosis. Eur Respir J. 2009 Feb;33(2):305-11. doi: 10.1183/09031936.00043108. Epub 2008 Nov 14.
- Background: PubMed 19372250Sly PD, Brennan S, Gangell C, de Klerk N, Murray C, Mott L, Stick SM, Robinson PJ, Robertson CF, Ranganathan SC; Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST-CF). Lung disease at diagnosis in infants with cystic fibrosis detected by newborn screening. Am J Respir Crit Care Med. 2009 Jul 15;180(2):146-52. doi: 10.1164/rccm.200901-0069OC. Epub 2009 Apr 16.
- Background: PubMed 19616787Stick SM, Brennan S, Murray C, Douglas T, von Ungern-Sternberg BS, Garratt LW, Gangell CL, De Klerk N, Linnane B, Ranganathan S, Robinson P, Robertson C, Sly PD; Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST CF). Bronchiectasis in infants and preschool children diagnosed with cystic fibrosis after newborn screening. J Pediatr. 2009 Nov;155(5):623-8.e1. doi: 10.1016/j.jpeds.2009.05.005. Epub 2009 Jul 19.
- Derived from this study: PubMed 35662406Stick SM, Foti A, Ware RS, Tiddens HAWM, Clements BS, Armstrong DS, Selvadurai H, Tai A, Cooper PJ, Byrnes CA, Belessis Y, Wainwright C, Jaffe A, Robinson P, Saiman L, Sly PD; COMBAT CF Study Group. The effect of azithromycin on structural lung disease in infants with cystic fibrosis (COMBAT CF): a phase 3, randomised, double-blind, placebo-controlled clinical trial. Lancet Respir Med. 2022 Aug;10(8):776-784. doi: 10.1016/S2213-2600(22)00165-5. Epub 2022 Jun 2.
- Telethon Institute for Child Health ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Peter D Sly, MMBS MD DSc study chair
The University of Queensland
Stephen M Stick, MBBChir PhD study chair
Telethon Kids Institute
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin in people with Cystic Fibrosis and Bronchiectasis, run by The University of Queensland at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, New Zealand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of children with radiologically-defined bronchiectasis (time frame: at three years of age). 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 NCT01270074, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.