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Tiny airways may hold big clues to asthma

NCT ID NCT02123667

Knowledge-focused Sponsor: Chiesi Farmaceutici S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers want to know whether problems in the smallest airways of the lungs explain why some people with asthma have worse symptoms. The study enrolls 872 adults aged 18 to 65 with a confirmed asthma diagnosis. Participants complete breathing tests and other assessments, and researchers follow them over time to compare small airways function with how their asthma behaves.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If researchers find a clear link between small airways problems and asthma symptoms, doctors could target those tiny airways more directly when treating patients.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The findings may not apply to all people with asthma, especially those outside the age range studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

872 people

The number who actually took part.

Started

Jun 2014

Finished

Mar 2017

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

900 subjects divided into 800 asthmatic patients and 100 healthy controls will be included. Recruitment will be balanced, at the extent possible, in order to achieve at least \> 150 patients each for steps 1 - 4 and \> 50 patients for step 5 as indicated in the international guidelines (GINA 2012) on the basis of their previous therapy. The 150 healthy controls will be recruited on the basis of absence of respiratory symptoms, airway obstruction and hyper responsiveness.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Asthmatic patient inclusion criteria 1. Male or female patients aged ≥ 18 and ≤ 65 years, who have signed an Informed Consent form 2. Clinical diagnosis of asthma f 1. Positive response to methacholine challenge test 2. Positive response to a reversibility test or 3. Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) \> 20% or 4. Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment. 3. Patients with stable asthma. 4. Current smoker, ex-smoker or lifelong non-smoker Healthy subject inclusion criteria 1\. Male or female patients aged ≥ 18 and ≤ 65 years 2. No clinical history of asthma or COPD 3. Current smoker, ex-smoker or lifelong non-smokers 4. Normal spirometry 5. Normal airways responsiveness Asthmatic patient exclusion criteria 1. Cigarette smoking \> 10 packyears 2. diagnosis of COPD 3. Asthma exacerbation in the 8 weeks prior to baseline visit 4. Clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might compromise the results or interpretation of the study. 5. Pregnant or lactating women 6. Participation in an interventional clinical trial \<12 weeks preceding baseline visit 7. Inability to comply with study procedures. 8. Alcohol or drug abuse. Healthy subject exclusion criteria 1\. Cigarette smoking history \> 10 packyears 2. Diagnosed upper and/or lower respiratory disease(s). 3. Clinical or functional uncontrolled haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that mightp compromise the results or interpretation of the study. 4\. Pregnant or lactating women 5. Participation in an interventional clinical trial \<12 weeks preceding baseline visit 6. Inability to comply with study procedures. 7. Alcohol or drug abuse.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Chetta

    Parma, Italy

  • Chiesi Clinical Trial Site #0101

    Naples, Italy

  • Chiesi Clinical Trial Site #0102

    Verona, 37134, Italy

  • Chiesi Clinical Trial Site #0103

    Pisa, 56124, Italy

  • Chiesi Clinical Trial Site #0104

    Ferrara, 44124, Italy

  • Chiesi Clinical Trial Site #0201

    Montreal, Quebec, H2X 2P4, Canada

  • Chiesi Clinical Trial Site #0301

    Hanover, 30625, Germany

  • Chiesi Clinical Trial Site #0302

    Leipzig, D-04357, Germany

  • Chiesi Clinical Trial Site #0303

    Großhansdorf, D-22927, Germany

  • Chiesi Clinical Trial Site #0401

    Lugo, 27003, Spain

  • Chiesi Clinical Trial Site #0402

    Barcelona, 08026, Spain

  • Chiesi Clinical Trial Site #0501

    Houston, Texas, 77030, United States

  • Chiesi Clinical Trial Site #0502

    Durham, North Carolina, 27710, United States

  • Chiesi Clinical Trial Site #0503

    Denver, Colorado, 80206, United States

  • Chiesi Clinical Trial Site #0504

    Cleveland, Ohio, 44106, United States

  • Dr. J. Vroegop

    Groningen, Netherlands

  • Dr. M. Broeders

    's-Hertogenbosch, Netherlands

  • Dr. M. vd Berge

    Groningen, Netherlands

  • Gao

    Beijing, Beijing Municipality, 100730, China

  • Prof. Dr. Alberto Cukier

    São Paulo, Brazil

  • Prof. Dr. Emilio Pizzichini

    Florianópolis, Brazil

  • Prof. Dr. Rafael Stelmach

    São Paulo, Brazil

  • Qingling Zhang

    Hangzhou, 510120, China

  • Scichilone

    Palermo, Italy

  • W. Boersma

    Alkmaar, Netherlands

  • Yuanlin Song

    Shanghai, Shanghai Municipality, 200032,, China

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