Cystic FibrosisNCT01460836
Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Novartis Pharmaceuticals.
Trial summary
Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tobramycin solution for inhalation and Aztreonam lysine for inhalation
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2010to Oct 2010
- 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,
- the ability to perform reproducible pulmonary function tests,
- Pseudomonas aeruginosa (PA) airway infection.
Who cannot join
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.
- Conditions
- Cystic Fibrosis
- Being tested
- Tobramycin solution for inhalation, Aztreonam lysine for inhalation
- Keywords
- Cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin solution for inhalationDrug
Aztreonam lysine for inhalationDrug
| Study group | Role | What they receive |
|---|---|---|
| Tobramycin Solution | Not described Receives: Drug: Tobramycin solution for inhalation | |
| Aztreonam lysine | Not described Receives: Drug: Aztreonam lysine for inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline
Measured: Baseline, Weeks 2, 4 and 6
Secondary outcomes (1)
Mean change in the density of Pseudomonas aeruginosa (PA) from baseline
Measured: Baseline, Weeks 2, 4 and 6
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 startApr 2010
- Primary completionOct 2010
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
- Time perspective
- Retrospective
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
- NCT01460836
- Sponsor's protocol ID
- HEORUS0017
- Status last verified
- Oct 2011
- First submitted
- 25 Oct 2011
- Last updated
- 27 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01460836
- Acronym / sponsor ID
- HEORUS0017
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- 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.
Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobramycin Solution | – | Drug: Tobramycin solution for inhalation |
| Aztreonam lysine | – | Drug: Aztreonam lysine for inhalation |
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 (4 listed)
- ≥ 6 years of age with a documented Cystic fibrosis (CF) diagnosis,
- moderate-to severe lung disease,
- the ability to perform reproducible pulmonary function tests,
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobramycin solution for inhalation | Drug | Tobramycin Solution |
| Aztreonam lysine for inhalation | Drug | Aztreonam lysine |
Primary outcome
Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline
Time frame: Baseline, Weeks 2, 4 and 6
1 secondary outcome
Mean change in the density of Pseudomonas aeruginosa (PA) from baseline
Time frame: Baseline, Weeks 2, 4 and 6
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 27 Oct 2011.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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 4 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: finished, as of the sponsor's last update on 27 Oct 2011. 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 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?
Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline (time frame: Baseline, Weeks 2, 4 and 6). 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 27 Oct 2011.