Cystic FibrosisPhase 3EDITNCT00918957
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
A Phase 3 study testing Tobramycin Inhalation Powder in people with Cystic Fibrosis, run by Novartis Pharmaceuticals at 24 sites in 9 countries.
Trial summary
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tobramycin Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 24 sitesin 9 countries
- Study dates
- Jun 2009to May 2011
- 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 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent given by adults or by the parents/legal guardian in combination with the patient's assent, if capable of assenting, before any assessment was performed
- Confirmed diagnosis of Cystic Fibrosis (CF) by the presence of one or more clinical features of CF in addition to:
- a quantitative pilocarpine iontophoresis sweat chloride test of >60 mEq/L; or
- identification of well-characterized disease-causing mutations in each CFTR gene; or
- an abnormal nasal transepithelial potential difference characteristic of CF.
- Forced Expiratory Volume in one second (FEV1) at screening must have been ≥25% and ≤80% of normal predicted values for age, sex, and height based on Knudson criteria
Show all 11Show fewer
- P. aeruginosa must have been present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/deep-throat cough swab culture at the screening visit
- Able to expectorate a sputum sample or provide a deep throat cough swab at screening
- Able to comply with all protocol requirements
- Use of an effective means of contraception in females of childbearing potential
- Clinically stable in the opinion of the investigator to be treated according to this protocol
Who cannot join
- FEV1 at baseline (Visit 2) <25% or >80% of normal predicted values for age, sex, and height based on Knudson criteria, and/or FEV1 at baseline (Visit 2) deviated by ≥10% from the FEV1 measured at screening (Visit 1)
- Any use of inhaled anti-pseudomonal antibiotics within 4 months prior to screening
- Any use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration
- Serum creatinine 2 mg/dL or above, blood urea nitrogen (BUN) 40 mg/dL or above, or an abnormal urinalysis defined as 2+ or greater proteinuria
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
- Signs and symptoms of acute pulmonary disease, e.g. pneumonia, pneumothorax
Show all 23Show fewer
- Administration of any investigational drug within 30 days prior to enrollment
- Any previous exposure to tobramycin dry powder for inhalation (TIP)
- Administration of loop diuretics within 7 days prior to study drug administration
- Initiation of treatment with chronic macrolide therapy within 28 days prior to study drug administration
- Initiation of treatment with dornase alfa within 28 days prior to study drug administration
- Initiation of treatment with inhaled steroids (or increased dose) within 28 days prior to study drug administration
- Initiation of treatment with inhaled hypertonic saline (HS) within 28 days prior to study drug administration
- Personal history of abnormal hearing or family history of abnormal hearing other than typical hearing loss associated with the aging process
- Known abnormal result from any audiology testing (defined as either a unilateral puretone audiometry test showing a threshold elevation >20 dB at any frequency across the frequency range 0.25 kHz to 8 kHz or the absence of emission at the evoked otoacoustic emission test)
- History of sputum culture or throat swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia) within 2 years prior to screening and/or sputum culture yielding B. cepacia at screening
- Hemoptysis of more than 60 mL at any time within 30 days prior to study drug administration
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of evidence of local recurrence or metastases
- Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
- Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they used two reliable birth control methods
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
24 sites in 9 countries.
24 sites in 9 countries
Russia6 sites
Novartis Investigative Site
Kazan'
Novartis Investigative Site
Moscow
Novartis Investigative Site
Saint Petersburg
Novartis Investigative Site
Samara
Novartis Investigative Site
Voronezh
Novartis Investigator Site
Yaroslavi
Bulgaria4 sites
Novartis Investigative Site
Pleven
Novartis Investigative Site
Plovdiv
Novartis Investigative Site
Sofia
Novartis Investigative Site
Varna
India4 sites
Novartis Investigative Site
Chandigarh
Novartis Investigative Site
Hyderabad
Novartis Investigative Site
New Delhi
Novartis Investigative Site
Vellore
Egypt2 sites
Novartis Investigative Site
Alexandria
Novartis Investigative Site
Giza
Estonia2 sites
Novartis Investigative Site
Tallinn
Novartis Investigative Site
Tartu
Lithuania2 sites
Novartis Investigative Site
Kaunas
Novartis Investigative Site
Vilnius
Romania2 sites
Novartis Investigative Site
Bucharest
Novartis Investigative Site
Timișoara
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
- Conditions
- Cystic Fibrosis
- Being tested
- Tobramycin Inhalation Powder, Placebo
- Keywords
- Tobramycin Inhalation Powder, Cystic fibrosis, Lung diseases, Anti-Bacterial Agents, Treatment of infections with P. aeruginosa in cystic fibrosis subjects
- Medical subject headings
- Cystic Fibrosis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin Inhalation PowderDrug
Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler.
PlaceboDrug
Placebo inhalation powder consisting of the excipients used for TIP. Placebo was provided in hard capsules, containing 20 mg placebo powder, which were packaged in blister cards, matching in appearance to TIP. Capsules were administered by the T-326 Inhaler.
| Study group | Role | What they receive |
|---|---|---|
| TIP (Tobramycin Inhalation Powder) | Experimental | Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. Receives: Drug: Tobramycin Inhalation Powder |
| Placebo | Placebo comparator | Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.), in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29)
Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.
ITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero.
BSL = Baseline, defined as the latest measurement prior to the first dosing of study medication
- Relative change = 100 * (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses.
Measured: Baseline, Day 29
Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29)
Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.
In the adjusted analysis model: response = treatment + screening FEV1 % predicted (<50 and >=50) + age (<13 and >=13) + error.
Significance for the FEV1 % predicted is reached for p-values <= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses.
Measured: Baseline, Day 29
Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier
Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.
Measured: Baseline, Day 29
Secondary outcomes (9)
Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57)
Results of statistical analysis were calculated from an ANOVA model. Baseline is defined as the latest measurement prior to the first dosing of study medication.
Response (percentage change) = treatment + Screening FEV1 percentage predicted (<50 and >=50) + age (<13 and >=13) + error
Measured: Baseline, Day 29, Day 57
Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57)
FEF25-75: Forced expiratory flow rate over 25% to 75% of vital capacity
For FEF25-75 percentage predicted the relative change is analyzed. If screening FEV1 percentage predicted is missing, it will be imputed by the baseline value.
Measured: Baseline, Day 29, Day 57
Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum)
- aeruginosa sputum density refers to overall density, defined as the sum of biotypes (mucoid, dry and small colony variant).
If sub-isolates exist for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed.
Measured: Baseline, Day 29, Day 57
Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC)
Maximum MIC values from all biotypes were used. Absolute values and changes in tobramycin MIC for P. aeruginosa from baseline are summarized by biotype. Overall, a high variability of MIC was observed within each treatment group. For the maximum of all biotypes, large differences in mean changes from baseline at Day 29 were observed between the TIP group and the placebo group.
Measured: Baseline, Day 29, Day 57
Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal
Hematology values shift from baseline to above upper/below lower limit of normal at any time post-baseline.
Biochemistry values shift from baseline to above upper/below lower limit of normal at any time post-baseline.
Measured: Baseline, Study completion
Percentage of Participants With Adverse Events (AEs)
Adverse Events (AEs) (on and off treatment) regardless of study relationship by primary system organ and treatment group.
Primary system organ classes are sorted in descending order of frequency in the TIP treatment group.
A patient with more than one AE within a primary system organ class is counted only once for that class.
Measured: First administration of study drug, study completion
Percentage of Participants With Serious Adverse Events (SAEs)
Serious Adverse Events (on and off treatment) by preferred term and treatment group.
Preferred terms are sorted in descending order of frequency in the TIP treatment group.
A patient with multiple occurrences of the same preferred term is counted only once in the preferred term.
Measured: Time of consent, 4 weeks after study completion
Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug
Relative change = 100 * (30-m-post-dose - pre-dose)/pre-dose assessed by the number and percentage of patients with a decrease of ≥20 % in FEV1 % predicted from pre dose to 30 minutes post dose.
Day 1 is the scheduled visit of first study drug administration.
Measured: Day 1, Day 29
Tobramycin Serum Concentration
Descriptive statistics of serum and sputum concentrations per scheduled sampling time.
Detectable concentration values at pre-dose on Day 1 were excluded from the analysis.
Measured: Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
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.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 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
- NCT00918957
- Sponsor's protocol ID
- CTBM100C2303
- Other IDs
- 2008-002318-22, 2008
- Acronym
- EDIT
- Status last verified
- Oct 2012
- First submitted
- 4 Jun 2009
- Last updated
- 3 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Galeva I, Konstan MW, Higgins M, Angyalosi G, Brockhaus F, Piggott S, Thomas K, Chuchalin AG. Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial. Curr Med Res Opin. 2013 Aug;29(8):947-56. doi: 10.1185/03007995.2013.805122. Epub 2013 Jun 5.
PubMed 23672633
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).
- ClinicalTrials.gov ID
- NCT00918957
- Acronym / sponsor ID
- EDIT / CTBM100C2303
- Conditions
- Cystic Fibrosis
- Keywords
- Tobramycin Inhalation Powder, Cystic fibrosis, Lung diseases, Anti-Bacterial Agents, Treatment of infections with P. aeruginosa in cystic fibrosis subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 3 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIP (Tobramycin Inhalation Powder) | Experimental | Drug: Tobramycin Inhalation PowderTobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.), in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Written informed consent given by adults or by the parents/legal guardian in combination with the patient's assent, if capable of assenting, before any assessment was performed
- Confirmed diagnosis of Cystic Fibrosis (CF) by the presence of one or more clinical features of CF in addition to:
- Forced Expiratory Volume in one second (FEV1) at screening must have been ≥25% and ≤80% of normal predicted values for age, sex, and height based on Knudson criteria
- P. aeruginosa must have been present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/deep-throat cough swab culture at the screening visit
- Able to expectorate a sputum sample or provide a deep throat cough swab at screening
Key exclusion criteria (23 listed)
- FEV1 at baseline (Visit 2) <25% or >80% of normal predicted values for age, sex, and height based on Knudson criteria, and/or FEV1 at baseline (Visit 2) deviated by ≥10% from the FEV1 measured at screening (Visit 1)
- Any use of inhaled anti-pseudomonal antibiotics within 4 months prior to screening
- Any use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration
- Serum creatinine 2 mg/dL or above, blood urea nitrogen (BUN) 40 mg/dL or above, or an abnormal urinalysis defined as 2+ or greater proteinuria
- Known local or systemic hypersensitivity to aminoglycosides or inhaled 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 |
|---|---|---|
| Tobramycin Inhalation PowderTobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler. | Drug | TIP (Tobramycin Inhalation Powder) |
| PlaceboPlacebo inhalation powder consisting of the excipients used for TIP. Placebo was provided in hard capsules, containing 20 mg placebo powder, which were packaged in blister cards, matching in appearance to TIP. Capsules were administered by the T-326 Inhaler. | Drug | Placebo |
Primary outcome
Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29)
Time frame: Baseline, Day 29
Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model. ITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero. BSL = Baseline, defined as the latest measurement prior to the first dosing of study medication - Relative change = 100 * (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses.
Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29)
Time frame: Baseline, Day 29
Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model. In the adjusted analysis model: response = treatment + screening FEV1 % predicted (<50 and >=50) + age (<13 and >=13) + error. Significance for the FEV1 % predicted is reached for p-values <= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses.
Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier
Time frame: Baseline, Day 29
Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.
9 secondary outcomes
Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57)
Time frame: Baseline, Day 29, Day 57
Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57)
Time frame: Baseline, Day 29, Day 57
Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum)
Time frame: Baseline, Day 29, Day 57
Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC)
Time frame: Baseline, Day 29, Day 57
Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal
Time frame: Baseline, Study completion
Percentage of Participants With Adverse Events (AEs)
Time frame: First administration of study drug, study completion
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Time of consent, 4 weeks after study completion
Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug
Time frame: Day 1, Day 29
Tobramycin Serum Concentration
Time frame: Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23672633Galeva I, Konstan MW, Higgins M, Angyalosi G, Brockhaus F, Piggott S, Thomas K, Chuchalin AG. Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial. Curr Med Res Opin. 2013 Aug;29(8):947-56. doi: 10.1185/03007995.2013.805122. Epub 2013 Jun 5.
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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
24 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tobramycin Inhalation Powder in people with Cystic Fibrosis, run by Novartis Pharmaceuticals at 24 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 11 inclusion and 23 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 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Russia, Bulgaria, India, Egypt, Estonia 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. 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 3 Oct 2012). 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?
Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) (time frame: Baseline, Day 29). The study lists 3 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 NCT00918957, 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 3 Oct 2012.