Cystic FibrosisNCT01460849
Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers
An observational study of Cystic Fibrosis, run by Novartis Pharmaceuticals.
Trial summary
Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from first year of TIS eligibility, estimate the increased risk of death attributable to each year of delayed TIS initiation, and investigate TIS effects across study centers. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cystic fibrosis
Who may be able to join
- ≥6 years of age with a documented Cystic fibrosis (CF) diagnosis,
- moderate-to-severe lung disease,
- Pseudomonas aeruginosa (PA) airway infection.
Who cannot join
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: Assess the Increased Mortality Risk With Each Year of Delayed TIS Initiation, and the Effect of TIS on Mortality Across Study Centers
Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from first year of TIS eligibility, estimate the increased risk of death attributable to each year of delayed TIS initiation, and investigate TIS effects across study centers.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tobramycin solution (TIS) initiation from first year of TIS eligibility
Secondary outcomes (1)
Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startMar 2011 (estimated)
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460849
- Sponsor's protocol ID
- HEORUS0088
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2011
- Last updated
- 7 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Increased Mortality Risk With Each Year of Delayed TIS Initiation, and the Effect of TIS on Mortality Across Study Centers
- ClinicalTrials.gov ID
- NCT01460849
- Acronym / sponsor ID
- HEORUS0088
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011 (estimated)
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 27 Oct 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.
Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from first year of TIS eligibility, estimate the increased risk of death attributable to each year of delayed TIS initiation, and investigate TIS effects across study centers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cystic fibrosis
Key inclusion criteria (3 listed)
- ≥6 years of age with a documented Cystic fibrosis (CF) diagnosis,
- moderate-to-severe lung disease,
- Pseudomonas aeruginosa (PA) airway infection.
Key exclusion criteria (1 listed)
- Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to tobramycin solution (TIS) initiation from first year of TIS eligibility
1 secondary outcome
Mortality
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Novartis Pharmaceuticals.
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 1 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: withdrawn, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 tobramycin solution (TIS) initiation from first year of TIS eligibility. 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 7 Dec 2021.