Asthma BronchialNCT07903805
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
An observational study of Asthma Bronchial, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
A low-intervention, prospective, experimental study will be conducted with the overall aim of assessing the inflammatory, functional and clinical differences between patients with asthma and those with asthma and hypertension, in order to improve our understanding of asthma and its comorbidities Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asthma Bronchial
- What is being tested?
- measurement of inflammatory markers
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- 23 Dec 2023to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two different groups of patients will be enrolled: patients with moderate-severe asthma (A), and patients with concomitant diagnosis of moderate-severe asthma and primary arterial hypertension (AH).
Who may be able to join
- Age ≥18 and ≤85 years;
- Diagnosis of moderate/severe asthma according to current Global Initiative for Asthma (GINA) guidelines
- Diagnosis of moderate/severe asthma according to current GINA guidelines and primary arterial hypertension according to current European Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines
- Patients able to collaborate in the required procedures;
- Signed informed consent.
Who cannot join
- History of asthma exacerbation requiring changing of pharmacological treatment in the previous month.
- Active smoking status or ex-smoker with Pack/Year major than 10;
- BMI major than 30 Kg/m2;
- Pregnancy;
- Diagnosis of concomitant Chronic Obstructive Pulmonary Disease (COPD); Obstructive Sleep Apnoea Syndrome (OSA); Clinically significant bronchiectasis; Allergic bronchopulmonary aspergillosis (ABPA); Atopic dermatitis;
- Diagnosis of concomitant Autoimmune Diseases; History of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or (Hepatitis C Virus)HCV ;
Show all 10Show fewer
- Active significant infection
- Malignancy, current or within the past 5 years. Suspected malignancy or undefined neoplasms;
- Cognitive impairment;
- History of clinically significant chronic heart diseases;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCSS ICS Maugeri Tradate
Tradate, Varese, 21049
Dina Visca, Professor, +39 0331829599, dina.visca@icsmaugeri.it
Francesco Ardesi, Medical Doctor, +39 0331829599, francesco.ardesi@icsmaugeri.it
About this study
A low-intervention, prospective, experimental study will be conducted with the overall aim of assessing the inflammatory, functional and clinical differences between patients with asthma and those with asthma and hypertension, in order to improve our understanding of asthma and its comorbidities
- Conditions
- Asthma Bronchial
- Being tested
- measurement of inflammatory markers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of inflammatory markersOther
measurement of inflammatory markers
| Study group | Role | What they receive |
|---|---|---|
| Asthma Patients | Not described Receives: Other: measurement of inflammatory markers | |
| Asthma Patients with hypertension | Not described Receives: Other: measurement of inflammatory markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 4
The primary objective of the study is to evaluate the different inflammatory characteristics between asthmatic patients with or without primary arterial hypertension.
Measured: at baseline and after 4 years
Interleukin 5
The primary objective of the study is to evaluate the different inflammatory characteristics between asthmatic patients with or without primary arterial hypertension.
Measured: at baseline and after 4 years
Interleukin 13
The primary objective of the study is to evaluate the different inflammatory characteristics between asthmatic patients with or without primary arterial hypertension.
Measured: at baseline and after 4 years
FEV1
Forced expiratory volume per second
Measured: at baseline and after 4 years
Secondary outcomes (2)
Asthma Control Questionnaire 5 (ACQ-5)
questionnaire
Measured: at baseline and after 4 years
Asthma Control Questionnaire 6 (ACQ-6)
questionnaire
Measured: at baseline and after 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start23 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903805
- Sponsor's protocol ID
- CTSM100-23
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma and Primary Arterial Hypertension: an Inflammatory Link?
- ClinicalTrials.gov ID
- NCT07903805
- Acronym / sponsor ID
- CTSM100-23
- Conditions
- Asthma Bronchial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 29 Oct 2026 (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.
A low-intervention, prospective, experimental study will be conducted with the overall aim of assessing the inflammatory, functional and clinical differences between patients with asthma and those with asthma and hypertension, in order to improve our understanding of asthma and its comorbidities
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Patients | – | Other: measurement of inflammatory markers |
| Asthma Patients with hypertension | – | Other: measurement of inflammatory markers |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two different groups of patients will be enrolled: patients with moderate-severe asthma (A), and patients with concomitant diagnosis of moderate-severe asthma and primary arterial hypertension (AH).
Key inclusion criteria (5 listed)
- Age ≥18 and ≤85 years;
- Diagnosis of moderate/severe asthma according to current Global Initiative for Asthma (GINA) guidelines
- Diagnosis of moderate/severe asthma according to current GINA guidelines and primary arterial hypertension according to current European Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines
- Patients able to collaborate in the required procedures;
- Signed informed consent.
Key exclusion criteria (10 listed)
- History of asthma exacerbation requiring changing of pharmacological treatment in the previous month.
- Active smoking status or ex-smoker with Pack/Year major than 10;
- BMI major than 30 Kg/m2;
- Pregnancy;
- Diagnosis of concomitant Chronic Obstructive Pulmonary Disease (COPD); Obstructive Sleep Apnoea Syndrome (OSA); Clinically significant bronchiectasis; Allergic bronchopulmonary aspergillosis (ABPA); Atopic dermatitis;
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 |
|---|---|---|
| measurement of inflammatory markersmeasurement of inflammatory markers | Other | Asthma Patients, Asthma Patients with hypertension |
Primary outcome
Interleukin 4
Time frame: at baseline and after 4 years
The primary objective of the study is to evaluate the different inflammatory characteristics between asthmatic patients with or without primary arterial hypertension.
Interleukin 5
Time frame: at baseline and after 4 years
The primary objective of the study is to evaluate the different inflammatory characteristics between asthmatic patients with or without primary arterial hypertension.
Interleukin 13
Time frame: at baseline and after 4 years
The primary objective of the study is to evaluate the different inflammatory characteristics between asthmatic patients with or without primary arterial hypertension.
FEV1
Time frame: at baseline and after 4 years
Forced expiratory volume per second
2 secondary outcomes
Asthma Control Questionnaire 5 (ACQ-5)
Time frame: at baseline and after 4 years
Asthma Control Questionnaire 6 (ACQ-6)
Time frame: at baseline and after 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Bronchial, run by Istituti Clinici Scientifici Maugeri SpA 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 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Visca, Professor (+39 0331829599, dina.visca@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin 4 (time frame: at baseline and after 4 years). The study lists 4 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 30 Oct 2026.