Study in Adult Patients With Moderate to Severe Asthma (FEEL)

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

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 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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A); Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence Inhaler A - Inhaler B (Period 1); 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.	Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A); 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.; Other Names: CHF1535 100/6 µg pMDI; Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B); 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.; Other Names: CHF1535 100/6 µg pMDI
Active Comparator: Sequence Inhaler B - Inhaler A (Period 2); 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.	Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A); 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.; Other Names: CHF1535 100/6 µg pMDI; Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B); 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.; Other Names: CHF1535 100/6 µg pMDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Treatment Day 14 within each treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Treatment Emergent Adverse Event (TEAEs), adverse drug reactions (ADRs), severe ADRs, serious ADRs, serious TEAEs (Serious Adverse Events), non-serious TEAEs, severe TEAEs	Occurrence of Treatment Emergent Adverse Event (TEAEs), adverse drug reactions (ADRs), severe ADRs, serious ADRs, serious TEAEs (Serious Adverse Events), non-serious TEAEs, severe TEAEs, TEAEs leading to discontinuation from study treatment and TEAEs leading to death. Summarised on the safety set by treatment group as the number of subjects, percentage of subjects, and number of events. All adverse events starting on or after the time of first study drug intake will be classified as TEAE. Any adverse events started after the informed consent signature and before the time of first study drug intake will be classified as pre-treatment adverse event.	From date of the first study drug intake unil date of study treatment, or date of death or up to 14 days after date of the last study drug intake, whichever came first

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #4	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. 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 #4 (How burdensome was your asthma yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), requiring subjects to rate the burden of their asthma symptoms from the previous day on a VAS scale ranging from 0 to 100, where 0=no burden at all and 100=very burdensome. Lower scores corresponded to better health and lower perceived burden of asthma. 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 by treatment are reported with their relative 95% IC.	Baseline and Treatment Day 14 within each treatment period
Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #5	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed 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). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #5 ("Did your asthma symptoms improve yesterday?") was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), using a VAS scale from 0 to 100 (0 = no improvement; 100 = maximum improvement), where higher scores indicated 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 with their 95% IC.	Baseline and Treatment Day 14 within each treatment period
Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #6	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed 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). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #6 ("Did your asthma symptoms worsen yesterday?") was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), using a VAS scale from 0 to 100 (0 = no worsening; 100 = maximum worsening), where lower scores indicated 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 with their relative 95% IC.	Baseline and Treatment Day 14 within each treatment period
Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #3	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed 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). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma symptoms were assessed using a VAS, ranging from 0=no symptoms to 100=very severe symptoms. Question #3 (How would you score your asthma symptoms yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43). First week value for each treatment period was defined as the average of the VAS scores that had been collected over the first week of treatment within each period. Change from baseline was calculated as the difference between the average VAS score from baseline (Day 1) and the average VAS score over the first 7 days of treatment. Adjusted means reported with their 95%IC.	Baseline and Treatment Day 7 within each treatment period
Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #4	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed 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). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma burden was assessed using a Visual Analogue Scale (VAS) ranging from 0=no burden to 100=very burdensome condition. Lower scores corresponded to better health. Question #4 (How burdensome was your asthma yesterday?) was recorded daily in the morning over the first 7 days of treatment. First week value for each treatment period = average of the VAS scores collected over the first week of treatment within each period. Here the change from baseline was calculated as the difference between the average VAS score from baseline (Day 1) and the average VAS score over the first 7 days of treatment.	Baseline and Treatment Day 7 within each treatment period
Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #5	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed 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). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma symptom improvement was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100, where 0 indicated no improvement at all and 100 indicated maximum improvement. Question #5 ("Did your asthma symptoms improve yesterday?") was recorded daily in the morning over the first 7 days of treatment. First week value for each treatment period was defined as the average of the VAS scores that had been collected over the first week of treatment within each period. The change from baseline was calculated as the difference between the average VAS score. Adjusted means are reported with their 95%IC	Baseline and Treatment Day 7 within each treatment period
Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #6	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed 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). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma symptom worsening was assessed using a VAS, ranging from 0=no worsening at all to 100= maximum worsening. Question #6 (Did your asthma symptoms worsen yesterday?) was recorded daily in the morning over the first 7 days of treatment. First week value for each treatment period was defined as the average of the VAS scores that had been collected over the first week of treatment within each period. The change from baseline was calculated as the difference between the average VAS score from baseline (Day 1) and the average VAS score over the first 7 days of treatment. Adjusted means are reported.	Baseline and Treatment Day 7 within each treatment period
Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #7	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #7 (Do you expect any improvement in asthma symptoms with this treatment?) was recorded at V2 (Day 15) and V3 (Day 29), before starting each treatment period. Expected asthma symptom improvement was assessed using a Visual Analogue Scale (VAS) ranging from 0=no expected improvement to 100=maximum expected improvement. Higher scores corresponded to greater expectations of benefit.Summary measures for this question were presented separately as descriptive statistics for the ITT population.	Baseline - V2 (Day 15)
Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #8	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #8 (Do you expect any worsening of your asthma symptoms with this treatment?) was recorded at V2 (Day 15) and V3 (Day 29), before starting each treatment period. Expected asthma symptom improvement was assessed using a Visual Analogue Scale (VAS) ranging from 0=none to 100=maximum worsening. Lower scores corresponded to better health. Summary measures for this question were presented separately as descriptive statistics for the ITT population.	Baseline - V2 (Day 15)
Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #9	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #9 ("How much do you think this treatment improved your overall asthma symptoms?") was recorded at V3 (Day 29) and V4 (Day 43), after each treatment period. Perceived improvement in overall asthma symptoms was assessed using a Visual Analogue Scale (VAS) ranging from 0 = none to 100 = maximum improvement. Higher scores corresponded to better health. Summary measures for this question were presented separately as descriptive statistics for the ITT population.	Study Day 14 of each treatment period
Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #10	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #10 ("How much do you think this treatment worsened your overall asthma symptoms?") was recorded at V3 (Day 29) and V4 (Day 43), after each treatment period. Perceived worsening of overall asthma symptoms was assessed using a Visual Analogue Scale (VAS) ranging from 0 = none to 100 = maximum worsening. Lower scores corresponded to better health. Summary measures for this question were presented separately as descriptive statistics for the ITT population.	Study Day 14 of each treatment period (V3 - Day 29 for Period 1 and V4 - Day 43 Period 2)
Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #11	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions was completed via an e-Diary. Questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' visual preference for the inhalers was assessed through Question #11 ("Which inhaler did you visually prefer?"). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Inhaler A, Inhaler B, or No preference. The number and percentage of subjects selecting one of the three options was summarized separately for the ITT population by treatment group.	Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview)
Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #12	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' preference for inhaler use was assessed through Question #12 ("Which inhaler did you prefer to use?"), which was answered only at V4 (Day 43). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Inhaler A, Inhaler B, or No preference. The number and percentage of subjects selecting one of the three options was summarized separately for the ITT population by treatment group.	Day 43 (V4, i.e.at the end of the entire treatment period during the Exit Interview)
Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #13	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of changes in the inhalers was assessed through Question #13 ("Do you think that changes were made to the inhalers?"), which was answered only at V4 (Day 43). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Yes, No, or I don't know. The number and percentage of subjects selecting one of the three options was summarized separately for the ITT population by treatment group.	Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview)
Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #14	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of the impact of inhaler changes on asthma symptoms was assessed through Question #14 ("Do you think that changes made across the inhalers have impacted your asthma symptoms?"), which was answered only at V4 (Day 43). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Yes, No, or I don't know. The number and % of subjects selecting one of the options was summarized separately for the ITT population by treatment group.	Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview)
Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #15	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of asthma symptoms after receiving information about the inhalers was assessed through Question #15 ("Based on the information you have received, did it impact your perception of your asthma symptoms?"), which was answered only at V4 (Day 43), after revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Yes, No, or I don't know. The number and % of subjects selecting one of the options was summarized separately for the ITT population by treatment group.	Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview)
Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #16	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of which inhaler had the biggest impact on their asthma symptoms was assessed through Question #16 ("Which of Inhaler A or Inhaler B had the biggest impact on the perception of your asthma symptoms?"), which was answered only at V4 (Day 43), after revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Inhaler A, Inhaler B, or I don't know. The number and % of subjects selecting one of the 3 options was reported separately by treatment group.	Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview)
Change From Baseline in Average Reliever Medication Use - Over the Entire 14-day Treatment - Question #2	A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while others were answered at specific study visit timepoints. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Rescue medication use was assessed through Question #2 (How many puffs of rescue medication have you taken yesterday?), answered daily every morning throughout the entire 14-day treatment period, from the day after V1 (Day 2) to the end of the study at V4 (Day 43). The average number of puffs per day was calculated for both the baseline and treatment periods, and the change from baseline was summarized separately for the ITT population by treatment group. Average value for each treatment period = mean number of puffs per day collected over Study Day 1 to Study Day 14 of each treatment period.	Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 for Period 2)
Change From Baseline in AQLQ Activity Limitation Score - After 14 Days of Treatment	Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains: Symptoms; Activity Limitation; Emotional Function; Environmental Stimuli Subjects were asked to respond on their condition over the previous 2 weeks via a 7-point scale, (7=not impaired at all; 1=severely impaired; higher score, better quality of life). AQLQ was administered at V2 (Day15) and V3 (Day29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered: improved: change in score>=0.5; worsened: change in score<=0.5; no change: -0.5<change score<0.5	Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2)
Change From Baseline in AQLQ Symptoms Score - After 14 Days of Treatment	Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains: Symptoms; Activity Limitation; Emotional Function; Environmental Stimuli Subjects were asked to respond on their condition over the previous 2 weeks via a 7-point scale, (7=not impaired at all; 1=severely impaired; higher score, better quality of life). AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered: improved: change in score>=0.5; worsened: change in score<=0.5; no change: -0.5<change score<0.5	Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2)
Change From Baseline in AQLQ Emotional Function Score - After 14 Days of Treatment	Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains: Symptoms; Activity Limitation; Emotional Function; Environmental Stimuli Subjects were asked to respond on their condition over the previous 2 weeks via a 7-point scale, (7=not impaired at all; 1=severely impaired; higher score, better quality of life). AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered: improved: change in score>=0.5; worsened: change in score<=0.5; no change: -0.5<change score<0.5	Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2)
Change From Baseline in AQLQ Environmental Stimuli Score - After 14 Days of Treatment	Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains: Symptoms; Activity Limitation; Emotional Function; Environmental Stimuli Subjects were asked to respond on their condition over the previous 2 weeks via a 7-point scale, (7=not impaired at all; 1=severely impaired; higher score, better quality of life). AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered: improved: change in score>=0.5; worsened: change in score<=0.5; no change: -0.5<change score<0.5	Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2)
Change From Baseline in AQLQ Overall Score - After 14 Days of Treatment	Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains: Symptoms; Activity Limitation; Emotional Function; Environmental Stimuli Subjects were asked to respond on their condition over the previous 2 weeks via a 7-point scale, (7=not impaired at all; 1=severely impaired; higher score, better quality of life). AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). Overall score = Σ scores of each 32 domains/ no. of available items in overall AQLQ (0-1)	Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2)
Occurrence of Treatment Emergent Adverse Event (TEAEs), Adverse Drug Reactions (ADRs), Severe ADRs, Serious ADRs, Serious TEAEs (Serious Adverse Events), Non-serious TEAEs, Severe TEAEs	An adverse event (AE) was defined as "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment". An AE could therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An adverse drug reaction (ADR) was defined as an "untoward and unintended response to an investigational medicinal product related to any dose administered". A serious adverse event (SAE)/serious ADR was defined as any untoward medical occurrence or effect that at any dose: Resulted in death; Was life-threatening; Required hospitalisation or prolongation of existing hospitalisation; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect; Was a medically significant AE.	From V1 (Day 1) to V4 (Day 43)

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Study Director: Eva Topole, MD, Chiesi Farmaceutici S.p.A.

Publications and helpful links

General 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.

Helpful Links

• Study Record on EU Clinical Trials Register including results

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Adherence; Asthma; Quality of life; Pressurised Metered-Dose Inhalers; Psychopharmacological; Authorized deception; CHF1535 100/6 µg pMDI; Inhaler A (white actuator); Inhaler B (pink actuator)
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Organic Chemicals; Polycyclic Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Alcohols; Pregnadienetriols; Amino Alcohols; Ethanolamines; Steroids, Chlorinated; Formoterol Fumarate; Beclomethasone
• Other Study ID Numbers: CLI-01535AA0-02; 2021-001449-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No