Respiratory Tract InfectionsPhase 4NCT00599417
PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
A Phase 4 study testing Bacterial Lysates in people with Respiratory Tract Infections, run by Sanofi at 1 site in Mexico.
Trial summary
Primary To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment Secondary To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second… Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Bacterial Lysates
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2007to Sep 2008
- Phase
- Phase 4
- 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 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with history of relapse or recurrence of respiratory infections or disease
- Patients with chronic respiratory disease as asthma, bronchitis or sinusitis
Who cannot join
- Patients unlikely to comply with the protocol, for example, uncooperativeness or impossibility to return for follow-up visits
- Patients who are participating or who have participated in another clinical trial during the previous 3 months
- Patients who have received immunology response stimulants during the previous 30 days
- Hypersensitivity
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Pivotal Unicentre, Randomized Double-bind, Placebo-controlled Study, to Evaluate Efficacy and Safety of Bacterial Lysates (Pulmonarom) in the Prevention of Respiratory Tract Infections
Primary
- To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment
Secondary
- To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment
- To evaluate loss of working or study days after second period of treatment
- To evaluate the safety and tolerability of Pulmonarom in the population under study
- Conditions
- Respiratory Tract Infections
- Being tested
- Bacterial Lysates, placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial LysatesDrug
Bacterial Lysates ampoules 3 mL, oral route, daily for 10 days, followed by 30 days free of medication and then 10 days of administration of the drug
placeboDrug
placebo controlled
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Bacterial Lysates |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of interleukin-4/interferon gamma index at baseline values
Measured: 60 days, 120 days
Secondary outcomes (1)
Adverse events and laboratory evaluation
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Judith Diaz, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599417
- Sponsor's protocol ID
- BACLY_L_03329
- Status last verified
- Sep 2009
- First submitted
- 11 Jan 2008
- Last updated
- 21 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Pivotal Unicentre, Randomized Double-bind, Placebo-controlled Study, to Evaluate Efficacy and Safety of Bacterial Lysates (Pulmonarom) in the Prevention of Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT00599417
- Acronym / sponsor ID
- BACLY_L_03329
- Conditions
- Respiratory Tract Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 23 Jan 2008 (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.
Primary
- To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment
Secondary
- To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment
- To evaluate loss of working or study days after second period of treatment
- To evaluate the safety and tolerability of Pulmonarom in the population under study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bacterial Lysates |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with history of relapse or recurrence of respiratory infections or disease
- Patients with chronic respiratory disease as asthma, bronchitis or sinusitis
Key exclusion criteria (5 listed)
- Patients unlikely to comply with the protocol, for example, uncooperativeness or impossibility to return for follow-up visits
- Patients who are participating or who have participated in another clinical trial during the previous 3 months
- Patients who have received immunology response stimulants during the previous 30 days
- Hypersensitivity
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| Bacterial LysatesBacterial Lysates ampoules 3 mL, oral route, daily for 10 days, followed by 30 days free of medication and then 10 days of administration of the drug | Drug | 1 |
| placeboplacebo controlled | Drug | 2 |
Primary outcome
Decrease of interleukin-4/interferon gamma index at baseline values
Time frame: 60 days, 120 days
1 secondary outcome
Adverse events and laboratory evaluation
Time frame: 120 days
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 21 Sep 2009.
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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.
Judith Diaz study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bacterial Lysates in people with Respiratory Tract Infections, run by Sanofi at 1 site in Mexico.
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 2 inclusion and 5 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 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Decrease of interleukin-4/interferon gamma index at baseline values (time frame: 60 days, 120 days). 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 21 Sep 2009.