Recurrent Respiratory Tract InfectionsPhase 4P-CRESCENTNCT04322669
Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)
A Phase 4 study testing Pidotimod in people with Recurrent Respiratory Tract Infections, run by Almirall, S.A. at 16 sites in China.
Trial summary
The purpose of this study is to assess the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Recurrent Respiratory Tract Infections
- What is being tested?
- Pidotimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 16 sitesChina
- Study dates
- 4 Aug 2021to 4 Nov 2021
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants having the study informed consent signed by their parent(s) / guardian. Participants will also assent specifically for their study participation signing an independent assent form. Site specific ethics requirements will be followed
- Participants with history of respiratory tract infections (Chinese Clinical Concept and management of recurrent respiratory tract infections in children [revised] (2008) (Zhonghua er ke za zhi = Chinese journal of Pediatrics; 46 (2): 108-10) of either:
- at least the following episodes of upper respiratory tract infections (ear/nose/throat) in the last year: 6 for those aged 3-5 years old at inclusion; 5 for those aged 6-14 years old at inclusion
- OR at least 2 episodes of lower respiratory tract infections (trachea/bronchia/lungs) in the last 12 months
- Participants compliant with the pidotimod Chinese approved label (package insert) requirements
Who cannot join
- Participants with any immunodeficiency condition, either primary or secondary (including Acquired immunodeficiency syndrome [AIDS], cancers of the immune system, immune-complex disease, chemotherapy, and radiation)
- Participants with known allergies or hypersensitivity to pidotimod or any of its excipients. Antibiotics allergic participant will not be excluded; but due warning will be given
- Participants with immunomodulatory treatment washout period of less than 4 weeks up to baseline visit
- Participants with any concomitant severe disease at the time of screening that are judged by the investigator that could be detrimental to the participant or could compromise the study (e.g. congenital heart disease, Rheumatic immune disease, congenital deformity of trachea, chronic pulmonary disease, chronic liver and kidney disease, etc)
- Female pregnant or of child bearing potential, for whom the investigator suspects might maintain sexual intercourse, unless she has a negative blood pregnancy test at screening and agrees to use two methods of contraception during the study
- Participants who has previously completed or withdrawn from this study
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- Participants with evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion
- Participants currently enrolled in, or discontinued within the last 30 days prior to baseline from a clinical study involving an off-label/new use of an investigational drug or device, or concurrently enrolled in a non-observational clinical study or any other type of medical research judged not to be scientifically or medically compatible with this study
- Participants who is unreliable and unwilling to make him/herself available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions
- Parents/Caregivers without cell phone, tablet or computer availability
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Investigator Site 01 Children's Hospital Captial Institute of Pediatrics
Beijing, 100020
Investigator Site 16
Changchun
Investigator Site 09
Changde
Investigator Site 12
Changsha
Investigator Site 07
Guangzhou
Investigator Site 10
Guilin
Investigator Site 14
Kunming
Investigator Site 03
Nanjing
Investigator Site 11
Sanya
Investigator Site 02
Shanghai
Investigator Site 06
Shantou
Investigator Site 13
Shaoyang
Investigator Site 05
Tianjin
Investigator Site 04
Xiamen
Investigator Site 08
Yanji
Investigator Site 15
Zhengzhou
About this study
Official title: Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI), A Randomized, Double Blind, Placebo Controlled Clinical Trial (P-CRESCENT)
The purpose of this study is to assess the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections.
- Conditions
- Recurrent Respiratory Tract Infections
- Being tested
- Pidotimod, Placebo
- Keywords
- Pidotimod, Recurrent Respiratory Tract Infections, Pediatrics Study
- 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.
PidotimodDrug
Participants will be randomized in ratio of 1:1 to receive Pidotimod 400 milligrams (mg), once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.
PlaceboDrug
Participants will be randomized in ratio of 1:1 to receive placebo matched to Pidotimod, once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Pidotimod | Experimental | Not described Receives: Drug: Pidotimod |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period
The mean rate of respiratory infection episodes per month during the overall study period will be analyzed and compared between the reported groups.
Measured: Baseline (Day 1) up to end of post-treatment follow-up [Day 180/Early Termination (ET)]
Secondary outcomes (29)
Rate of Respiratory Tract Infection (RI) per Month During the Post-treatment Follow-up Period
The mean rate of RI episodes per month during the post-treatment follow-up period will be analyzed.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Rate of Respiratory Tract Infection (RI) per Month During the Double-blind Randomized Period
The RI per month during the double-blind randomized treatment period will be assessed.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Days with Respiratory Tract Infections (RI) During the Double-blind Treatment Period
The number of days with RI during the double-blind treatment period will be assessed.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Days with Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
The number of days with RI during the post-treatment follow-up will be assessed.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Days with Respiratory Tract Infections (RI) During the Overall Study Period
The number of days with RI during the overall period will be assessed.
Measured: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Antibiotic Use Days During the Double-blind Treatment Period
The number of antibiotic use days due to any respiratory infection during the double-blind treatment period will be assessed.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Antibiotic Use Days During the Post-treatment Follow-up Period
The number of antibiotic use days due to any respiratory infection during the post-treatment follow-up period will be assessed.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Antibiotic Use Days During the Overall Period
The number of antibiotic use days due to any respiratory infection during the overall period will be assessed.
Measured: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Antipyretics Use Days During the Double-blind Treatment Period
The number of antipyretics use days during the double-blind treatment period will be assessed.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Antipyretics Use Days During the Post-Treatment Follow-up Period
The number of antipyretics use days due to any respiratory infection during the post-treatment follow-up period will be assessed.
The number of antipyretics use days during the double-blind 60-day treatment period will be assessed.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Antipyretics Use Days During the Overall Period
The number of antipyretics use days due to any respiratory infection during the overall period will be assessed.
Measured: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Double-blind Treatment Period
The percentage of participants free of RI during the double-blind treatment period will be assessed.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
The percentage of participants free of RI during the post-treatment follow-up period will be assessed.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Overall Period
The percentage of participants free of RI during the overall period will be assessed.
Measured: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Hospitalization Days During the Double-blind Treatment Period
The number of hospitalization days due to any respiratory infection during the double-blind treatment period will be assessed.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Hospitalization Days During the Post-treatment Follow-up Period
The number of hospitalization days due to any respiratory infections during the post-treatment follow-up period will be assessed.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Hospitalization Days During the Overall Period
The number of hospitalization days due to any respiratory infections during the overall period will be assessed.
Measured: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Percentage of Participants with At Least One Hospitalization During the Double-blind Treatment Period
The percentage of participants with at least one hospitalization due to any respiratory infections during the double-blind treatment period will be assessed.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Percentage of Participants with At Least One Hospitalization During the Post-treatment Follow-Up Period
The percentage of participants with at least one hospitalization due to any respiratory infections during the post-treatment follow-up period will be assessed.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Percentage of Participants with At Least One Hospitalization During the Overall Period
The percentage of participants with at least one hospitalization due to any respiratory infections during the overall period will be assessed.
Measured: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Wheezing Attack Days During the Double-blind Treatment Period
The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the double-blind treatment period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Wheezing Attack Days During the Post-treatment Follow-up Period
The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the post-treatment follow-up period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Wheezing Attack Days During the Overall Period
The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the during the overall period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another.
Measured: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Asthma Days During the Double-blind Treatment Period
The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the double-blind treatment period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Asthma Days During the Post-treatment Follow-up Period
The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the post-treatment follow-up period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Asthma Days During the Overall Period
The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the overall period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness.
Measured: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Participants with Adverse Events (AE) During the Double-blind Treatment Period
An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the double-blind treatment.
Measured: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Participants with Adverse Events (AE) During the Post-treatment Follow-up Period
An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the post-treatment follow- up.
Measured: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Participants with Adverse Events (AE) During the Overall Period
An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the overall study.
Measured: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start4 Aug 2021
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The 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
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322669
- Sponsor's protocol ID
- M-PIMOT-40
- Acronym
- P-CRESCENT
- Status last verified
- Feb 2022
- First submitted
- 24 Mar 2020
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI), A Randomized, Double Blind, Placebo Controlled Clinical Trial (P-CRESCENT)
- ClinicalTrials.gov ID
- NCT04322669
- Acronym / sponsor ID
- P-CRESCENT / M-PIMOT-40
- Conditions
- Recurrent Respiratory Tract Infections
- Keywords
- Pidotimod, Recurrent Respiratory Tract Infections, Pediatrics Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 26 Mar 2020 (actual)
- 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 the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pidotimod | Experimental | Drug: Pidotimod |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participants having the study informed consent signed by their parent(s) / guardian. Participants will also assent specifically for their study participation signing an independent assent form. Site specific ethics requirements will be followed
- Participants with history of respiratory tract infections (Chinese Clinical Concept and management of recurrent respiratory tract infections in children [revised] (2008) (Zhonghua er ke za zhi = Chinese journal of Pediatrics; 46 (2): 108-10) of either:
- Participants compliant with the pidotimod Chinese approved label (package insert) requirements
Key exclusion criteria (10 listed)
- Participants with any immunodeficiency condition, either primary or secondary (including Acquired immunodeficiency syndrome [AIDS], cancers of the immune system, immune-complex disease, chemotherapy, and radiation)
- Participants with known allergies or hypersensitivity to pidotimod or any of its excipients. Antibiotics allergic participant will not be excluded; but due warning will be given
- Participants with immunomodulatory treatment washout period of less than 4 weeks up to baseline visit
- Participants with any concomitant severe disease at the time of screening that are judged by the investigator that could be detrimental to the participant or could compromise the study (e.g. congenital heart disease, Rheumatic immune disease, congenital deformity of trachea, chronic pulmonary disease, chronic liver and kidney disease, etc)
- Female pregnant or of child bearing potential, for whom the investigator suspects might maintain sexual intercourse, unless she has a negative blood pregnancy test at screening and agrees to use two methods of contraception during the study
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 |
|---|---|---|
| PidotimodParticipants will be randomized in ratio of 1:1 to receive Pidotimod 400 milligrams (mg), once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period. | Drug | Pidotimod |
| PlaceboParticipants will be randomized in ratio of 1:1 to receive placebo matched to Pidotimod, once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period. | Drug | Placebo |
Primary outcome
Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up [Day 180/Early Termination (ET)]
The mean rate of respiratory infection episodes per month during the overall study period will be analyzed and compared between the reported groups.
29 secondary outcomes
Rate of Respiratory Tract Infection (RI) per Month During the Post-treatment Follow-up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Rate of Respiratory Tract Infection (RI) per Month During the Double-blind Randomized Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Days with Respiratory Tract Infections (RI) During the Double-blind Treatment Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Days with Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Days with Respiratory Tract Infections (RI) During the Overall Study Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Antibiotic Use Days During the Double-blind Treatment Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Antibiotic Use Days During the Post-treatment Follow-up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Antibiotic Use Days During the Overall Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Antipyretics Use Days During the Double-blind Treatment Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Antipyretics Use Days During the Post-Treatment Follow-up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Antipyretics Use Days During the Overall Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Double-blind Treatment Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Percentage of Participants Free of Respiratory Tract Infections (RI) During the Overall Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Hospitalization Days During the Double-blind Treatment Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Hospitalization Days During the Post-treatment Follow-up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Hospitalization Days During the Overall Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Percentage of Participants with At Least One Hospitalization During the Double-blind Treatment Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Percentage of Participants with At Least One Hospitalization During the Post-treatment Follow-Up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Percentage of Participants with At Least One Hospitalization During the Overall Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Wheezing Attack Days During the Double-blind Treatment Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Wheezing Attack Days During the Post-treatment Follow-up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Wheezing Attack Days During the Overall Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Asthma Days During the Double-blind Treatment Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Asthma Days During the Post-treatment Follow-up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Asthma Days During the Overall Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Number of Participants with Adverse Events (AE) During the Double-blind Treatment Period
Time frame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
Number of Participants with Adverse Events (AE) During the Post-treatment Follow-up Period
Time frame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
Number of Participants with Adverse Events (AE) During the Overall Period
Time frame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
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 2 Feb 2022.
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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.
Study Director study director
Almirall, S.A.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pidotimod in people with Recurrent Respiratory Tract Infections, run by Almirall, S.A. at 16 sites in China.
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 5 inclusion and 10 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 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. 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?
Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period (time frame: Baseline (Day 1) up to end of post-treatment follow-up [Day 180/Early Termination (ET)]). 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 2 Feb 2022.