AsthmaPhase 3FEELNCT04886999

Study in Adult Patients With Moderate to Severe Asthma

A Phase 3 study testing Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A) and Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B) in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 10 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study assessed the influence of pink vs. white pressurized metered-dose inhaler (pMDI) actuators on asthma symptoms perception. There was no prespecified primary objective. The following objectives were assessed: Change from baseline in average visual analog scale (VAS) score of the perception of asthma symptoms… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Asthma
What is being tested?: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A) and Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 10 sitesItaly
Study dates: 24 Feb 2022to 1 Feb 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject's and/or subject legal representative's written informed consent obtained prior to any study related procedure.
Age: ≥18 and ≤75 years of age.
Established diagnosis of permanent asthma for at least 6 months prior to screening/randomisation visit
Subject on maintenance therapy treated by Foster® (CHF1535 100/6 µg pMDI) for at least 6 months prior to screening/randomisation visit
Asthma Control Test (ACT) ≥ 20 at screening/randomisation visit.
Subject must have a cooperative attitude and the ability to be trained to use correctly the diary and answer the Visual Analogue Scale (VAS)
Subject willing and able to download the application on their personal electronic device to fill in the study e-diary.
Female subject of non-childbearing potential defined as physiologically incapable of becoming pregnant or female subject + male Partner must be willing to use a highly effective birth control method from the signature of the informed consent and until Visit 4

Who cannot join

Pregnant or lactating woman
History of 'at risk' asthma
Recent exacerbation
Non-permanent asthma
Asthma requiring more than 1 inhaler for maintenance treatment and more than 1 inhaler for reliever treatment.
Asthma requiring use of biologics

Show all 18Show fewer

Respiratory disorders
Lower tract respiratory infection
Current smoker or ex-smoker with a smoking current use/history of ≥ 10 pack-years
Cardiovascular diseases
Subject with historical or current evidence of uncontrolled concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease, haematological disease and autoimmune disorders
Alcohol/drug abuse
Participation in an investigational trial within the last 30 days (60 days for biologics) or a more appropriate time as determined by the Investigator
Contra-indications to Foster® constituted an exclusion criterion
History of hypersensitivity to Foster® or any of its components or a history of any other allergy that in the opinion of the Investigator contra-indicated the subject's participation
Subject mentally or legally incapacitated or subject accommodated in an establishment as a result of an official or judicial order
Blind, colour-blind subject or any other dyschromatopsia
Known psychiatric disorders that may have interfered with successful completion of this protocol according to the Investigator's judgment including schizophrenia, bipolar disorders and psychoses.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Italy10 sites

Chiesi Clinical Trial Site 38011
Bari
Chiesi Clinical Trial Site 38009
Battipaglia
Chiesi Clinical Trial Site 38006
Cagliari
Chiesi Clinical Trial Site 38010
Catanzaro
Chiesi Clinical Trial Site 38003
Genova
Chiesi Clinical Trial Site 38001
Milan
Chiesi Clinical Trial Site 38005
Naples
Chiesi Clinical Trial Site 38004
Palermo
Chiesi Clinical Trial Site 38002
Roma
Chiesi Clinical Trial Site 38007
Sassari

Other trials in Italy

About this study

Official title: An Exploratory, Double-blind, Randomised, Multicenter, Psychopharmacological Study in Adult Patients With Moderate to Severe Asthma to Compare Two Pressurised Metered-Dose Inhalers (pMDIs) on Patients' Perception of Asthma Symptoms

Change from baseline in average visual analog scale (VAS) score of the perception of asthma symptoms and burden over the first 7 days and all 14 days in each treatment period (Questions 3-6);
Change from baseline in AQLQ score after 14 days of treatment in each period;
Summary measures of psychopharmacological aspects (Questions 7-10);
Patients' preference and perception of the devices (Questions 11-16);
Change from baseline in reliever medication use over 14 days of treatment in each period (Question 2).

For both treatment periods, "baseline" for the questionnaire data was the 14-day period prior to the first treatment period, and for AQLQ was the value recorded at Visit 2.

Read the detailed description

This was a phase IIIb, exploratory, double-blind, randomised, multicentre, psychopharmacological, 2x2 cross-over study in adult subjects with moderate to severe asthma.

A total of 78 randomised subjects in 10 actives centres were involved. The study focused on the psychopharmacological aspects, particularly on the subjects' preference for the device and on the impact of the device's features on subjects' perception of asthma symptoms. Subjects were informed that the study treatments were the same medication they had received before enrolment as maintenance therapy (i.e. Foster® 100/6 µg pMDI), but with differing device characteristics.

The study lasted approximately 6 weeks for each subject and comprised four visits (Visit [V] 1 to V4), including:

Two face-to-face clinic visits: V1 (Day 1, screening/randomisation visit) and V4 (Day 43);
Two remote video contact visits: V2 (Day 15) and V3 (Day 29).

After signing the ICF, subjects were screened at the investigational site during the screening/randomisation visit (V1). On the same day, and after checking all inclusion and exclusion criteria, eligible subjects were randomised to one of two study treatment sequences and followed the study treatment sequence as follows:

From V1 (Day 1), subjects were treated with commercial Foster® 100/6 µg pMDI during the 14-day baseline period;
From V2 (Day 15), subjects were instructed to take CHF1535 100/6 µg pMDI via Inhaler A and Inhaler B during two consecutive periods of 14 days each (first and second treatment periods) in a sequential way dictated by the randomisation:
Either CHF1535 100/6 µg pMDI with Inhaler A then CHF1535 100/6 µg pMDI with Inhaler B; or
CHF1535 100/6 µg pMDI with Inhaler B then CHF1535 100/6 µg pMDI with Inhaler A.

The first treatment period started at V2 (Day 15) and the second treatment period started at V3 (Day 29), with the end of study visit taking place at V4 (Day 43). A window of ±1 day was allowed for the dates of all study visits except V1 (Day 1).

Please note that "Change from baseline in average VAS score perceptions of asthma-over the 14 Days of treatment - Question #3" was reported as PRIMARY ENDPOINT to comply with CT.gov register requirements, but it should be considered as an OTHER PRE-SPECIFIED endpoint like the other endpoint listed.

Conditions: Asthma
Being tested: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A), Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)
Keywords: Asthma, Pressurised Metered-Dose Inhalers, Psychopharmacological, Authorized deception, Quality of life, Adherence, CHF1535 100/6 µg pMDI, Inhaler A (white actuator), Inhaler B (pink actuator)
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A)Drug
Also called CHF1535 100/6 µg pMDI
Administered via Inhaler A (white actuator) as two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study.
Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)Drug
Also called CHF1535 100/6 µg pMDI
Administered via Inhaler B (pink actuator) as two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study.

Study groups in NCT04886999
Study group	Role	What they receive
Sequence Inhaler A - Inhaler B (Period 1)	Experimental	Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler A (white actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator. After completing the first treatment period, participants switched to Inhaler B (pink actuator) for another 14 days. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate. There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption. Receives: Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A); Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)
Sequence Inhaler B - Inhaler A (Period 2)	Active comparator	Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler B (pink actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator. After completing the first treatment period, participants switched to Inhaler A (white actuator) for another 14-day treatment period. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate. There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption. Receives: Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A); Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3
A study-specific questionnaire was developed to evaluate medication use, asthma symptoms, and treatment perception. It consisted of 16 questions, completed by subjects via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). The questionnaire included Visual Analogue Scale (VAS) ratings, numerical responses, and multiple-choice questions, with VAS primarily used to assess symptom perception and psychopharmacological effects.
Question #3 (How would you score your asthma symptoms yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), with subjects rating their asthma symptoms from the previous day on a VAS scale from 0=no symptoms to 100=very symptomatic, with lower scores corresponding to better health. The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means are reported.
Measured: Baseline and Treatment Day 14 within each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 20221 Feb 2023

First posted14 May 2021
Study start24 Feb 2022
Primary completion1 Feb 2023
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Chiesi Farmaceutici S.p.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 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04886999
Sponsor's protocol ID: CLI-01535AA0-02
Other IDs: 2021-001449-11
Acronym: FEEL
Status last verified: Mar 2026
First submitted: 27 Apr 2021
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Blasi F, D'Amato M, Patella V, Topole E, Bucchioni E, Martini M, Geraci S, Grapin F, Van der Deijl M, Colloca L. Evaluating the impact of changing inhaler color on perception of symptoms and disease burden in patients with asthma: the FEEL study. J Asthma. 2025 May;62(5):841-849. doi: 10.1080/02770903.2024.2448317. Epub 2025 Jan 17.
PubMed 39772981

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory, Double-blind, Randomised, Multicenter, Psychopharmacological Study in Adult Patients With Moderate to Severe Asthma to Compare Two Pressurised Metered-Dose Inhalers (pMDIs) on Patients' Perception of Asthma Symptoms
ClinicalTrials.gov ID: NCT04886999
Acronym / sponsor ID: FEEL / CLI-01535AA0-02
Conditions: Asthma
Keywords: Asthma, Pressurised Metered-Dose Inhalers, Psychopharmacological, Authorized deception, Quality of life, Adherence, CHF1535 100/6 µg pMDI, Inhaler A (white actuator)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
Study start: 24 Feb 2022 (actual)
Primary completion: 1 Feb 2023 (actual)
Study completion: 1 Feb 2023 (actual)
First posted: 14 May 2021 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Change from baseline in average visual analog scale (VAS) score of the perception of asthma symptoms and burden over the first 7 days and all 14 days in each treatment period (Questions 3-6);
Change from baseline in AQLQ score after 14 days of treatment in each period;
Summary measures of psychopharmacological aspects (Questions 7-10);
Patients' preference and perception of the devices (Questions 11-16);
Change from baseline in reliever medication use over 14 days of treatment in each period (Question 2).

For both treatment periods, "baseline" for the questionnaire data was the 14-day period prior to the first treatment period, and for AQLQ was the value recorded at Visit 2.

Detailed description

This was a phase IIIb, exploratory, double-blind, randomised, multicentre, psychopharmacological, 2x2 cross-over study in adult subjects with moderate to severe asthma.

The study lasted approximately 6 weeks for each subject and comprised four visits (Visit [V] 1 to V4), including:

Two face-to-face clinic visits: V1 (Day 1, screening/randomisation visit) and V4 (Day 43);
Two remote video contact visits: V2 (Day 15) and V3 (Day 29).

From V1 (Day 1), subjects were treated with commercial Foster® 100/6 µg pMDI during the 14-day baseline period;
From V2 (Day 15), subjects were instructed to take CHF1535 100/6 µg pMDI via Inhaler A and Inhaler B during two consecutive periods of 14 days each (first and second treatment periods) in a sequential way dictated by the randomisation:
Either CHF1535 100/6 µg pMDI with Inhaler A then CHF1535 100/6 µg pMDI with Inhaler B; or
CHF1535 100/6 µg pMDI with Inhaler B then CHF1535 100/6 µg pMDI with Inhaler A.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study

Arm	Type	Receives
Sequence Inhaler A - Inhaler B (Period 1)	Experimental	Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A), Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler A (white actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator. After completing the first treatment period, participants switched to Inhaler B (pink actuator) for another 14 days. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate. There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption.
Sequence Inhaler B - Inhaler A (Period 2)	Active comparator	Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A), Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler B (pink actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator. After completing the first treatment period, participants switched to Inhaler A (white actuator) for another 14-day treatment period. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate. There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject's and/or subject legal representative's written informed consent obtained prior to any study related procedure.
Age: ≥18 and ≤75 years of age.
Established diagnosis of permanent asthma for at least 6 months prior to screening/randomisation visit
Subject on maintenance therapy treated by Foster® (CHF1535 100/6 µg pMDI) for at least 6 months prior to screening/randomisation visit
Asthma Control Test (ACT) ≥ 20 at screening/randomisation visit.

Key exclusion criteria (18 listed)

Pregnant or lactating woman
History of 'at risk' asthma
Recent exacerbation
Non-permanent asthma
Asthma requiring more than 1 inhaler for maintenance treatment and more than 1 inhaler for reliever treatment.

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
Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A)Also: CHF1535 100/6 µg pMDIAdministered via Inhaler A (white actuator) as two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study.	Drug	Sequence Inhaler A - Inhaler B (Period 1), Sequence Inhaler B - Inhaler A (Period 2)
Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)Also: CHF1535 100/6 µg pMDIAdministered via Inhaler B (pink actuator) as two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study.	Drug	Sequence Inhaler A - Inhaler B (Period 1), Sequence Inhaler B - Inhaler A (Period 2)

Primary outcome

Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3
Time frame: Baseline and Treatment Day 14 within each treatment period
A study-specific questionnaire was developed to evaluate medication use, asthma symptoms, and treatment perception. It consisted of 16 questions, completed by subjects via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). The questionnaire included Visual Analogue Scale (VAS) ratings, numerical responses, and multiple-choice questions, with VAS primarily used to assess symptom perception and psychopharmacological effects. Question #3 (How would you score your asthma symptoms yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), with subjects rating their asthma symptoms from the previous day on a VAS scale from 0=no symptoms to 100=very symptomatic, with lower scores corresponding to better health. The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means are reported.

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence: Inhaler A - Inhaler B	39	36
Sequence: Inhaler B - Inhaler A	39	36

Primary outcome: Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3

Time frame: Baseline and Treatment Day 14 within each treatment period. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Inhaler A n = 71	Inhaler B n = 71
Value	2.68 (0.99 to 4.37)	1.63 (-0.06 to 3.32)

Inhaler A vs Inhaler B: Adjusted Mean Difference: 1.05 (95% CI -1.34 to 3.45), p = 0.385, Mixed Models Analysis

Population analysed: Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account for the calculation of the treatment difference. n=71 is the number of patients with available data, not the general number of subjects in the ITT set (N=72 for Inhaler A and N=74 for the Inhaler B).

Adverse events

Time frame: Throughout the study, from Visit 1 (Day 1 - study screening and along the baseline period [Day 1- Day 14]) until Visit 4 (Day 43 ± 1 day, i.e. the end of the second treatment period).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inhaler A - SAF Population	0 of 72 (0%)	7 of 72 (9.7%)	0 of 72
Inhaler B - SAF Population	0 of 74 (0%)	6 of 74 (8.1%)	0 of 74
Overall	0 of 74 (0%)	11 of 74 (14.9%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 39772981Blasi F, D'Amato M, Patella V, Topole E, Bucchioni E, Martini M, Geraci S, Grapin F, Van der Deijl M, Colloca L. Evaluating the impact of changing inhaler color on perception of symptoms and disease burden in patients with asthma: the FEEL study. J Asthma. 2025 May;62(5):841-849. doi: 10.1080/02770903.2024.2448317. Epub 2025 Jan 17.
Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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.

Eva Topole, MD study director

Chiesi Farmaceutici S.p.A.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 18 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3 (time frame: Baseline and Treatment Day 14 within each treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04886999, which also lists 1 linked publication.

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 27 Mar 2026.