Respiratory and Allergic SymptomsPhase 4CLIMACTIONSNCT04742179
Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits.
A Phase 4 study testing Manteinance and care intervention on the green areas. in people with Respiratory and Allergic Symptoms, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
This is a prospective, non-randomized, controlled, interventional study aiming to assess, in a primary school in the city of Palermo, the health effects of a maintenance and care intervention of the school's green areas. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Respiratory and Allergic Symptoms
- What is being tested?
- Manteinance and care intervention on the green areas.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2022to 11 May 2022
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male or female gender
- age between 7 and 11 years
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, non-randomized, controlled, interventional study aiming to assess, in a primary school in the city of Palermo, the health effects of a maintenance and care intervention of the school's green areas.
All children of the third, fourth and fifth classes of two school complexes of the same primary school will be selected. One complex will undergo maintenance and care of the green areas and gardens inside the school. The other complex will serve as a control group and will not undergo any intervention.
Read more
The study will involve three phases.
- During the first phase (prior to the intervention) respiratory and allergic symptoms will be assessed through a standardized questionnaire to be administered to students, parents and teachers in both the school complexes.
- During the second phase, the maintenance and care intervention plan will be implemented in the experimental complex.
- During the third phase, 1 week after the maintenance intervention, respiratory and allergic symptoms will be re-assessed through a standardized questionnaire to be administered to the same students, parents and teachers in both the school complexes.
- Conditions
- Respiratory and Allergic Symptoms
- Being tested
- Manteinance and care intervention on the green areas.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manteinance and care intervention on the green areas.Other
Manteinance and care intervention on the green areas.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The children belonging to the classes of the school complex undergoing the maintenance intervention. Receives: Other: Manteinance and care intervention on the green areas. |
| Control group | No intervention | The children belonging to the classes of the school complex that will not undergo the maintenance intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma symptoms at baseline
Presence of asthma symptoms before the maintenance intervention
Measured: Before the maintenance intervention
Rhinitis symptoms at baseline
Presence of rhinitis symptoms before the maintenance intervention
Measured: Before the maintenance intervention
Conjunctivitis symptoms at baseline
Presence of conjunctivitis symptoms before the maintenance intervention
Measured: Before the maintenance intervention
Asthma symptoms at follow-up
Presence of asthma symptoms after the maintenance intervention
Measured: 7 days after the maintenance intervention
Rhinitis symptoms at follow-up
Presence of rhinitis symptoms after the maintenance intervention
Measured: 7 days after the maintenance intervention
Conjunctivitis symptoms at follow-up
Presence of conjunctivitis symptoms after the maintenance intervention
Measured: 7 days after the maintenance intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start11 Jan 2022
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory and Allergic SymptomsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742179
- Sponsor's protocol ID
- 11/2020
- Acronym
- CLIMACTIONS
- Status last verified
- Dec 2022
- First submitted
- 28 Jan 2021
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits.
- ClinicalTrials.gov ID
- NCT04742179
- Acronym / sponsor ID
- CLIMACTIONS / 11/2020
- Conditions
- Respiratory and Allergic Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 5 Feb 2021 (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.
This is a prospective, non-randomized, controlled, interventional study aiming to assess, in a primary school in the city of Palermo, the health effects of a maintenance and care intervention of the school's green areas.
All children of the third, fourth and fifth classes of two school complexes of the same primary school will be selected. One complex will undergo maintenance and care of the green areas and gardens inside the school. The other complex will serve as a control group and will not undergo any intervention.
The study will involve three phases.
- During the first phase (prior to the intervention) respiratory and allergic symptoms will be assessed through a standardized questionnaire to be administered to students, parents and teachers in both the school complexes.
- During the second phase, the maintenance and care intervention plan will be implemented in the experimental complex.
- During the third phase, 1 week after the maintenance intervention, respiratory and allergic symptoms will be re-assessed through a standardized questionnaire to be administered to the same students, parents and teachers in both the school complexes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Manteinance and care intervention on the green areas.The children belonging to the classes of the school complex undergoing the maintenance intervention. |
| Control group | No intervention | –The children belonging to the classes of the school complex that will not undergo the maintenance intervention. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- male or female gender
- age between 7 and 11 years
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| Manteinance and care intervention on the green areas.Manteinance and care intervention on the green areas. | Other | Experimental group |
Primary outcome
Asthma symptoms at baseline
Time frame: Before the maintenance intervention
Presence of asthma symptoms before the maintenance intervention
Rhinitis symptoms at baseline
Time frame: Before the maintenance intervention
Presence of rhinitis symptoms before the maintenance intervention
Conjunctivitis symptoms at baseline
Time frame: Before the maintenance intervention
Presence of conjunctivitis symptoms before the maintenance intervention
Asthma symptoms at follow-up
Time frame: 7 days after the maintenance intervention
Presence of asthma symptoms after the maintenance intervention
Rhinitis symptoms at follow-up
Time frame: 7 days after the maintenance intervention
Presence of rhinitis symptoms after the maintenance intervention
Conjunctivitis symptoms at follow-up
Time frame: 7 days after the maintenance intervention
Presence of conjunctivitis symptoms after the maintenance intervention
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 23 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Manteinance and care intervention on the green areas. in people with Respiratory and Allergic Symptoms, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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 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 23 Dec 2022. 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 Italy. 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. 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?
Asthma symptoms at baseline (time frame: Before the maintenance intervention). The study lists 6 primary outcomes in all. 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 23 Dec 2022.