ClinicalTrials.gg
RecruitingNCT07903805Updated Oct 30, 2026

Asthma and Primary Arterial Hypertension: an Inflammatory Link?

An observational study in Asthma Bronchial, sponsored by Istituti Clinici Scientifici Maugeri SpA. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Istituti Clinici Scientifici Maugeri SpA · Observational

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 10 months later.
Updated Oct 30, 2026Eligibility revisedNewly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
74
Ages
18 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Asthma Bronchial

Browse trials for

03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 74 is below the median of 158 across 1,250 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 126 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 30, 2026. See what changed

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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;
  • major than 30 Kg/m2;
  • Pregnancy;
  • Diagnosis of concomitant (COPD); Obstructive Sleep Apnoea Syndrome (OSA); bronchiectasis; Allergic bronchopulmonary aspergillosis (ABPA); Atopic dermatitis;
  • Diagnosis of concomitant Diseases; History of (HIV), Virus (HBV), or ( Virus)HCV ;
  • Active significant infection
  • , current or within the past 5 years. Suspected malignancy or undefined neoplasms;
  • Cognitive impairment;
  • History of clinically significant chronic heart diseases;
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
74 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Asthma Patients

    Other: measurement of inflammatory markers

  • Asthma Patients with hypertension

    Other: measurement of inflammatory markers

Interventions

  • Othermeasurement of inflammatory markers

    measurement of inflammatory markers

06

What researchers measure

Primary outcomes

  1. Interleukin 4

    The primary objective of the study is to evaluate the different inflammatory characteristics between asthmatic patients with or without primary arterial hypertension.

    Time frame: at baseline and after 4 years

  2. Interleukin 5

    The primary objective of the study is to evaluate the different inflammatory characteristics between asthmatic patients with or without primary arterial hypertension.

    Time frame: at baseline and after 4 years

  3. Interleukin 13

    The primary objective of the study is to evaluate the different inflammatory characteristics between asthmatic patients with or without primary arterial hypertension.

    Time frame: at baseline and after 4 years

  4. FEV1

    Forced expiratory volume per second

    Time frame: at baseline and after 4 years

Secondary outcomes

  1. Asthma Control Questionnaire 5 (ACQ-5)

    questionnaire

    Time frame: at baseline and after 4 years

  2. Asthma Control Questionnaire 6 (ACQ-6)

    questionnaire

    Time frame: at baseline and after 4 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2023 (actual). Primary completion is estimated for Dec 2028, 60 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2026
First posted
Oct 29, 2026
StartActual
Dec 23, 2023
Primary completionEst.
Dec 31, 2028
CompletionEst.
Jun 30, 2029
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
2 inclusion criteria edited; 1 exclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedDiagnosis of moderate/severe asthma according to current Global Initiative for Asthma (GINA) guidelines
  • EditedDiagnosis 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
Exclusion criteria
  • EditedDiagnosis of concomitant Autoimmune Diseases; History of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or (Hepatitis C Virus)HCV ;
Oct 30, 2026
Registered
First appeared on the registry
Oct 29, 2026
Show all 2 updates
  1. Oct 30, 2026
    Eligibility 2 inclusion criteria edited; 1 exclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedDiagnosis of moderate/severe asthma according to current Global Initiative for Asthma (GINA) guidelines
    • EditedDiagnosis 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
    Exclusion criteria
    • EditedDiagnosis of concomitant Autoimmune Diseases; History of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or (Hepatitis C Virus)HCV ;
  2. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07903805
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Dec 23, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

Dina Visca, Professor
Contact
dina.visca@icsmaugeri.it
+39 0331829599
Francesco Ardesi, Medical doctor
Contact
francesco.ardesi@icsmaugeri.it
+39 0331 829599

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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