Cystic FibrosisPhase 2/3SHIP-CTNCT02950883
Saline Hypertonic in Preschoolers + CT
A Phase 2/3 study testing Active Treatment Group 7% Hypertonic Saline in people with Cystic Fibrosis, run by University of Washington, the Collaborative Health Studies Coordinating Center at 25 sites in 9 countries.
Trial summary
The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Active Treatment Group 7% Hypertonic Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 25 sitesin 9 countries
- Study dates
- 24 Mar 2015to 25 Jun 2021
- Phase
- Phase 2/3
- 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of CF as evidenced by one or more clinical features consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:
- A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
- A documented genotype with two disease-causing mutations in the CFTR gene
- Informed consent by parent or legal guardian
- Age ≥ 36 months and ≤72 months at screening visit
- Ability to comply with medication use, study visits and study procedures as judged by the site investigator
- Ability to cooperate with chest CT at the enrollment visit as determined by the lung function technician
Who cannot join
- Chest CT within 8 months prior to the Screening visit
- Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding screening or enrollment visit
- Acute wheezing at screening or enrollment visit
- Oxygen saturation < 95% (<90% in centers located above 4000 feet elevation) at screening or enrollment visit
- Other major organ dysfunction, excluding pancreatic dysfunction
- Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
Show all 11Show fewer
- Investigational drug use within 30 days prior to screening or enrollment visit
- Treatment with inhaled HS at any concentration within 30 days prior to screening or enrollment visit
- Initiation (i.e. new prescription) of any inhaled hydrating agent such as mannitol or mucolytic agents such as dornase alpha within 30 days prior to the screening or enrollment visit
- Chronic lung disease not related to CF
- Inability to tolerate first dose of study treatment at the enrollment visit
Trial locations and contacts
25 sites in 9 countries.
25 sites in 9 countries
United States7 sites
Children's Hospital of Colorado
Aurora, Colorado, 80045
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Oregon Health Sciences University
Portland, Oregon, 97239
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110
Australia7 sites
Royal Women's and Children Hospital
Adelaide
Lady Cilento Children's Hospital
Brisbane
Royal Children's Hospital
Melbourne
John Hunter Children's Hospital
Newcastle
Children's Hospital at Westmead
Sydney
Sydney Children's Hospital at Randwick
Sydney
Perth Children's Hospital
West Perth
Belgium2 sites
Universitair Ziekenhuis Children's Hospital
Brussels
UZ Leuven - Gasthuisberg Ziekenhuis
Leuven
Canada2 sites
Hospital for Sick Kids
Toronto, Ontario, M5G1X8
British Columbia Children's Hospital
Vancouver, British Columbia, V6H3V4
Italy2 sites
Bambini Gesu Children's Hospital
Roma, 00165
Ospedale Civile Maggiore
Verona, 37126
Netherlands1 site
Sophia Children's Hospital at Erasmus Medical Centre
Rotterdam
About this study
Official title: Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT)
The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.
Read the detailed description
Several observational studies have shown that cystic fibrosis (CF) patients less than or equal to 6 years of age have clinically silent airway damage. There is growing interest in early initiation of therapies to prevent or delay the progression of this lung disease in CF. In SHIP-CT, the investigators will evaluate treatment effects of HS relative to IS on measures of structural lung disease obtained from chest CT using a novel scoring system sensitive to early lung changes, the Perth-Rotterdam Annotated Grid Morphometric Analysis method for CF (PRAGMA-CF), that quantifies the volume percentage of diseased airways (%Dis), bronchiectasis (%Bx), and trapped air (%TA). As a secondary evaluation of structural airway damage, the investigators will use an image analysis system to measure airway dimensions relative to adjacent arteries (AA-system). Longitudinal changes in CT measures will also be compared to changes in lung function measured by the lung clearance index (LCI) obtained by N2 Multiple Breath Washout (MBW) and to clinical outcomes.
The primary hypothesis is that HS will reduce structural lung disease as assessed by the PRAGMA-CF computed tomography score relative to IS during the 48-week treatment period among preschool children with CF.
SHIP-CT is a parallel study to SHIP001 (ClinicalTrials.gov Identifier NCT02378467). The primary hypothesis of SHIP001, which runs in North America, is that compared to IS, HS will improve the LCI, a measure of ventilation heterogeneity, during the 48-week treatment period among preschool children with CF. The SHIP-CT study (SHIP002) will use a nearly identical study design as the SHIP001 study, with similar eligibility criteria and treatment arms, to determine whether HS reduces structural lung disease as measured by chest computed tomography (CT), in addition to stabilizing or improving functional outcomes as measured by LCI.
This is a multicenter, randomized, double-blind, controlled, parallel group trial assessing structural lung disease in children with CF ages 3 to 5 at enrollment. Participants will be randomized 1:1 to receive 7% hypertonic saline (treatment arm) vs. 0.9% isotonic saline (control arm) administered twice daily via jet nebulizer for 48 weeks. Study visits will occur at screening, enrollment, and at Weeks 12, 24, 36, and 48. Parents or the legal guardian will be contacted at Weeks 1, 4 and 8 to document changes in health status, adverse events, concomitant medications/treatments, and encourage study treatment compliance. Parents or the legal guardian will also be contacted approximately every 6 weeks between visit 3, 4, 5, and 6 to address individual issues or concerns related to study treatment or study participation, and to document changes in health status, medications and treatments.
Total duration of participant participation will be up to 53 weeks. As enrollment will occur over approximately 18 months, total duration of the study is expected to be up to 30 months (18 months enrollment plus 12 months for the last participants to complete study participation).
- Conditions
- Cystic Fibrosis
- Being tested
- Active Treatment Group 7% Hypertonic Saline, Control Group 0.9% Isotonic Saline
- Keywords
- Cystic Fibrosis, Hypertonic Saline, Inhaled Saline, Digestive System Diseases, Genetic Diseases, Inborn, Lung Diseases, Pancreatic Diseases, Pathologic Processes, Respiratory Tract Diseases, Computed Tomography (CT)
- Medical subject headings
- Cystic Fibrosis, Digestive System Diseases, Genetic Diseases, Inborn, Lung Diseases, Pancreatic Diseases, Pathologic Processes, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Treatment Group 7% Hypertonic SalineDrug
Drug: 7% Hypertonic Saline (HS) 4 mL of HS will be administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI compressor (PARI Vios® Pro in USA, PARI BOY SX in Australia and Europe).
Other Names:
Hyper-Sal™, inhaled saline
Control Group 0.9% Isotonic SalineDrug
Drug: 0.9% Isotonic Saline (IS) 4 mL of IS will be administered via inhalation twice daily for 48 weeks The delivery system is the same as that for the test product.
Other Names: Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | 7% Hypertonic Saline administered via inhalation twice daily for 48 weeks Receives: Drug: Active Treatment Group 7% Hypertonic Saline |
| Control Group | Active comparator | 0.9% Isotonic Saline administered via inhalation twice daily for 48 weeks Receives: Drug: Control Group 0.9% Isotonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest CT
The difference in PRAGMA-CF %Dis between HS and IS study arm at end of study (48 weeks), adjusted for baseline, measured from standardized chest CT.
Measured: 48 weeks
Secondary outcomes (3)
PRAGMA-CF Sub-scores
- The difference in PRAGMA-CF sub-scores, %Bx (the volume proportion of the lung with bronchiectasis) and %TA (the volume proportion of the lung with trapped air), between the baseline CT and the 48 week CT. ii) The absolute number of airways, airway dimensions and AA ratios from TLC CTs, acquired at the 48-week visit.
Measured: 48 weeks
Lung Clearance Index (LCI)
The difference in LCI, measured by N2 MBW, from baseline to 48 weeks
Measured: 48 weeks
Cross-sectional and longitudinal relationships
Cross-sectional and longitudinal relationships between primary and secondary PRAGMA-CF outcomes (%Dis, %Bx and %TA) and MBW outcomes (LCI), airway dimensions and PRAGMA-CF and MBW outcomes, as well as CFQ-R scores and PRAGMA-CF and MBW
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start24 Mar 2015
- Primary completion15 Dec 2020
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington, the Collaborative Health Studies Coordinating Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Harm Tiddens, MD, PhD, Principal investigator, Erasmus Medical Centre, RotterdamStephen Stick, MD, PhD, Principal investigator, Telethon Kids Institute, PerthMargaret Rosenfeld, MD, MPH, Principal investigator, Seattle Children's Hospital, SeattleStephanie Davis, MD, Principal investigator, Indiana University, IndianapolisFelix Ratjen, MD, PhD, FRCPC, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950883
- Sponsor's protocol ID
- SHIP002
- Acronym
- SHIP-CT
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2016
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rosenow T, Oudraad MC, Murray CP, Turkovic L, Kuo W, de Bruijne M, Ranganathan SC, Tiddens HA, Stick SM; Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST CF). PRAGMA-CF. A Quantitative Structural Lung Disease Computed Tomography Outcome in Young Children with Cystic Fibrosis. Am J Respir Crit Care Med. 2015 May 15;191(10):1158-65. doi: 10.1164/rccm.201501-0061OC.
PubMed 25756857Ramsey KA, Rosenow T, Turkovic L, Skoric B, Banton G, Adams AM, Simpson SJ, Murray C, Ranganathan SC, Stick SM, Hall GL; AREST CF. Lung Clearance Index and Structural Lung Disease on Computed Tomography in Early Cystic Fibrosis. Am J Respir Crit Care Med. 2016 Jan 1;193(1):60-7. doi: 10.1164/rccm.201507-1409OC.
PubMed 26359952Tiddens HAWM, Chen Y, Andrinopoulou ER, Davis SD, Rosenfeld M, Ratjen F, Kronmal RA, Hinckley Stukovsky KD, Dasiewicz A, Stick SM; SHIP-CT Study Group. The effect of inhaled hypertonic saline on lung structure in children aged 3-6 years with cystic fibrosis (SHIP-CT): a multicentre, randomised, double-blind, controlled trial. Lancet Respir Med. 2022 Jul;10(7):669-678. doi: 10.1016/S2213-2600(21)00546-4. Epub 2022 Mar 11.
PubMed 35286860
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT)
- ClinicalTrials.gov ID
- NCT02950883
- Acronym / sponsor ID
- SHIP-CT / SHIP002
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Hypertonic Saline, Inhaled Saline, Digestive System Diseases, Genetic Diseases, Inborn, Lung Diseases, Pancreatic Diseases, Pathologic Processes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of Washington, the Collaborative Health Studies Coordinating CenterUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 24 Mar 2015 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 1 Nov 2016 (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 purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.
Detailed description
Several observational studies have shown that cystic fibrosis (CF) patients less than or equal to 6 years of age have clinically silent airway damage. There is growing interest in early initiation of therapies to prevent or delay the progression of this lung disease in CF. In SHIP-CT, the investigators will evaluate treatment effects of HS relative to IS on measures of structural lung disease obtained from chest CT using a novel scoring system sensitive to early lung changes, the Perth-Rotterdam Annotated Grid Morphometric Analysis method for CF (PRAGMA-CF), that quantifies the volume percentage of diseased airways (%Dis), bronchiectasis (%Bx), and trapped air (%TA). As a secondary evaluation of structural airway damage, the investigators will use an image analysis system to measure airway dimensions relative to adjacent arteries (AA-system). Longitudinal changes in CT measures will also be compared to changes in lung function measured by the lung clearance index (LCI) obtained by N2 Multiple Breath Washout (MBW) and to clinical outcomes.
The primary hypothesis is that HS will reduce structural lung disease as assessed by the PRAGMA-CF computed tomography score relative to IS during the 48-week treatment period among preschool children with CF.
SHIP-CT is a parallel study to SHIP001 (ClinicalTrials.gov Identifier NCT02378467). The primary hypothesis of SHIP001, which runs in North America, is that compared to IS, HS will improve the LCI, a measure of ventilation heterogeneity, during the 48-week treatment period among preschool children with CF. The SHIP-CT study (SHIP002) will use a nearly identical study design as the SHIP001 study, with similar eligibility criteria and treatment arms, to determine whether HS reduces structural lung disease as measured by chest computed tomography (CT), in addition to stabilizing or improving functional outcomes as measured by LCI.
This is a multicenter, randomized, double-blind, controlled, parallel group trial assessing structural lung disease in children with CF ages 3 to 5 at enrollment. Participants will be randomized 1:1 to receive 7% hypertonic saline (treatment arm) vs. 0.9% isotonic saline (control arm) administered twice daily via jet nebulizer for 48 weeks. Study visits will occur at screening, enrollment, and at Weeks 12, 24, 36, and 48. Parents or the legal guardian will be contacted at Weeks 1, 4 and 8 to document changes in health status, adverse events, concomitant medications/treatments, and encourage study treatment compliance. Parents or the legal guardian will also be contacted approximately every 6 weeks between visit 3, 4, 5, and 6 to address individual issues or concerns related to study treatment or study participation, and to document changes in health status, medications and treatments.
Total duration of participant participation will be up to 53 weeks. As enrollment will occur over approximately 18 months, total duration of the study is expected to be up to 30 months (18 months enrollment plus 12 months for the last participants to complete study participation).
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 |
|---|---|---|
| Active Treatment Group | Experimental | Drug: Active Treatment Group 7% Hypertonic Saline7% Hypertonic Saline administered via inhalation twice daily for 48 weeks |
| Control Group | Active comparator | Drug: Control Group 0.9% Isotonic Saline0.9% Isotonic Saline administered via inhalation twice daily for 48 weeks |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosis of CF as evidenced by one or more clinical features consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:
- Informed consent by parent or legal guardian
- Age ≥ 36 months and ≤72 months at screening visit
- Ability to comply with medication use, study visits and study procedures as judged by the site investigator
- Ability to cooperate with chest CT at the enrollment visit as determined by the lung function technician
Key exclusion criteria (11 listed)
- Chest CT within 8 months prior to the Screening visit
- Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding screening or enrollment visit
- Acute wheezing at screening or enrollment visit
- Oxygen saturation < 95% (<90% in centers located above 4000 feet elevation) at screening or enrollment visit
- Other major organ dysfunction, excluding pancreatic dysfunction
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 |
|---|---|---|
| Active Treatment Group 7% Hypertonic SalineDrug: 7% Hypertonic Saline (HS) 4 mL of HS will be administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI compressor (PARI Vios® Pro in USA, PARI BOY SX in Australia and Europe). Other Names: Hyper-Sal™, inhaled saline | Drug | Active Treatment Group |
| Control Group 0.9% Isotonic SalineDrug: 0.9% Isotonic Saline (IS) 4 mL of IS will be administered via inhalation twice daily for 48 weeks The delivery system is the same as that for the test product. Other Names: Normal saline | Drug | Control Group |
Primary outcome
Chest CT
Time frame: 48 weeks
The difference in PRAGMA-CF %Dis between HS and IS study arm at end of study (48 weeks), adjusted for baseline, measured from standardized chest CT.
3 secondary outcomes
PRAGMA-CF Sub-scores
Time frame: 48 weeks
Lung Clearance Index (LCI)
Time frame: 48 weeks
Cross-sectional and longitudinal relationships
Time frame: 48 weeks
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 12 Mar 2024.
- Background: PubMed 25756857Rosenow T, Oudraad MC, Murray CP, Turkovic L, Kuo W, de Bruijne M, Ranganathan SC, Tiddens HA, Stick SM; Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST CF). PRAGMA-CF. A Quantitative Structural Lung Disease Computed Tomography Outcome in Young Children with Cystic Fibrosis. Am J Respir Crit Care Med. 2015 May 15;191(10):1158-65. doi: 10.1164/rccm.201501-0061OC.
- Background: PubMed 26359952Ramsey KA, Rosenow T, Turkovic L, Skoric B, Banton G, Adams AM, Simpson SJ, Murray C, Ranganathan SC, Stick SM, Hall GL; AREST CF. Lung Clearance Index and Structural Lung Disease on Computed Tomography in Early Cystic Fibrosis. Am J Respir Crit Care Med. 2016 Jan 1;193(1):60-7. doi: 10.1164/rccm.201507-1409OC.
- Results publication: PubMed 35286860Tiddens HAWM, Chen Y, Andrinopoulou ER, Davis SD, Rosenfeld M, Ratjen F, Kronmal RA, Hinckley Stukovsky KD, Dasiewicz A, Stick SM; SHIP-CT Study Group. The effect of inhaled hypertonic saline on lung structure in children aged 3-6 years with cystic fibrosis (SHIP-CT): a multicentre, randomised, double-blind, controlled trial. Lancet Respir Med. 2022 Jul;10(7):669-678. doi: 10.1016/S2213-2600(21)00546-4. Epub 2022 Mar 11.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
Not yet recruitingPhase 4
Iron Repletion in Cystic Fibrosis
Cystic Fibrosis, Iron Deficiencies
Recruiting
Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
Cystic Fibrosis (CF), Bronchiectasis, Non-Cystic Fibrosis
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
PERCE-MUCO: Perceptions and Expectations of People With Cystic Fibrosis Regarding a Change in Treatment
Cystic Fibrosis (CF)
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.
Harm Tiddens, MD, PhD principal investigator
Erasmus Medical Centre, Rotterdam
Stephen Stick, MD, PhD principal investigator
Telethon Kids Institute, Perth
Margaret Rosenfeld, MD, MPH principal investigator
Seattle Children's Hospital, Seattle
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Active Treatment Group 7% Hypertonic Saline in people with Cystic Fibrosis, run by University of Washington, the Collaborative Health Studies Coordinating Center at 25 sites in 9 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 7 inclusion and 11 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Australia, Belgium, Canada, France and 4 more countries. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Chest CT (time frame: 48 weeks). 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 NCT02950883, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.