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

Primary Purpose

Asthma

Status
Active
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Exploratory study on patient's perception of Asthma symptoms
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; autoimmune disorders
  • Alcohol/drug abuse

Sites / Locations

  • Chiesi 38011
  • Chiesi 38009
  • Chiesi 38006
  • Chiesi 38010
  • Chiesi 38003
  • Chiesi 38001
  • Chiesi 38005
  • Chiesi 38004
  • Chiesi 38002
  • Chiesi 38007

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhaler A CHF1535 100/6 µg pMDI

Inhaler B CHF1535 100/6 µg pMDI

Arm Description

Active ingredient: Fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg. Excipients: HFA-134a, Ethanol anhydrous, Hydrochloric acid. Presentation: Canister containing 120 doses plus actuator.

Active ingredient: Fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg. Excipients: HFA-134a, Ethanol anhydrous, Hydrochloric acid. Presentation: Canister containing 120 doses plus actuator

Outcomes

Primary Outcome Measures

Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 15 (Visit 2)
Assessed by Visual Analogue Scale (VAS) that ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome. Each question will be analysed separately.
Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 29 (Visit 3)
Assessed by Visual Analogue Scale (VAS) that ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome. Each question will be analysed separately.
Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 43 (Visit 4)
Assessed by Visual Analogue Scale (VAS) that ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome. Each question will be analysed separately.
Percentages of subjects (for questions with categorical outcome) to evaluate patients' preference of device at Day 43 (Visit 4)
Questions covering patients' preference of device and outcome assessments will be reported on the ITT and PP set by treatment group. This analysis will be applied on questions not collected daily. Each question will be analysed separately.
Percentages of subjects (for questions with categorical outcome) to evaluate patients' perception of inhalers changes at Day 43 (Visit 4)
Questions covering patients' preference of device and outcome assessments will be reported on the ITT and PP set by treatment group. This analysis will be applied on questions not collected daily. Each question will be analysed separately.
Change from baseline in average Visual Analogic Scale score of subjects' perceptions of asthma symptoms after 14 days of treatment
Visual Analogue Scale (VAS) ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome.
Change from baseline in average Visual Analogic Scale score of subjects' perceptions of asthma symptoms after the first 7 days of treatment
Visual Analogue Scale (VAS) ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome.
Change from baseline in rescue medication use
To be summarised on the "Intention To Treat" set by treatment group by descriptive statistics. Baseline value is defined as the average value (puffs/day) collected during the baseline period.
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score
There are 32 questions in the AQLQ that are divided in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). Answers are done on a 7-point scale (7 = not impaired at all - 1 = severely impaired), with higher scores indicating better quality of life.

Secondary Outcome Measures

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.

Full Information

First Posted
April 27, 2021
Last Updated
June 12, 2023
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04886999
Brief Title
Study in Adult Patients With Moderate to Severe Asthma
Acronym
FEEL
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
July 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The CLI-01535AA02-2 Study is an exploratory study designed to compare two pressurised metered Dose inhalers on subject's perception of asthma symptoms.
Detailed Description
Outpatients attending the hospital clinics/study centers will be recruited. Moderate to severe asthma adult subjects will be recruited. A total of 75 subjects will be enrolled. The whole study will last approximately 6 weeks for each subject.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaler A CHF1535 100/6 µg pMDI
Arm Type
Experimental
Arm Description
Active ingredient: Fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg. Excipients: HFA-134a, Ethanol anhydrous, Hydrochloric acid. Presentation: Canister containing 120 doses plus actuator.
Arm Title
Inhaler B CHF1535 100/6 µg pMDI
Arm Type
Active Comparator
Arm Description
Active ingredient: Fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg. Excipients: HFA-134a, Ethanol anhydrous, Hydrochloric acid. Presentation: Canister containing 120 doses plus actuator
Intervention Type
Behavioral
Intervention Name(s)
Exploratory study on patient's perception of Asthma symptoms
Intervention Description
To assess the perception of symptoms and the psychopharmacological aspects in patients with moderate to severe asthma comparing two inhalers of CHF1535 100/6 µg pMDI
Primary Outcome Measure Information:
Title
Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 15 (Visit 2)
Description
Assessed by Visual Analogue Scale (VAS) that ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome. Each question will be analysed separately.
Time Frame
At Day 15 (Visit 2)
Title
Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 29 (Visit 3)
Description
Assessed by Visual Analogue Scale (VAS) that ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome. Each question will be analysed separately.
Time Frame
At Day 29 (Visit 3)
Title
Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 43 (Visit 4)
Description
Assessed by Visual Analogue Scale (VAS) that ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome. Each question will be analysed separately.
Time Frame
At Day 43 (Visit 4)
Title
Percentages of subjects (for questions with categorical outcome) to evaluate patients' preference of device at Day 43 (Visit 4)
Description
Questions covering patients' preference of device and outcome assessments will be reported on the ITT and PP set by treatment group. This analysis will be applied on questions not collected daily. Each question will be analysed separately.
Time Frame
At Day 43 (Visit 4)
Title
Percentages of subjects (for questions with categorical outcome) to evaluate patients' perception of inhalers changes at Day 43 (Visit 4)
Description
Questions covering patients' preference of device and outcome assessments will be reported on the ITT and PP set by treatment group. This analysis will be applied on questions not collected daily. Each question will be analysed separately.
Time Frame
At Day 43 (Visit 4)
Title
Change from baseline in average Visual Analogic Scale score of subjects' perceptions of asthma symptoms after 14 days of treatment
Description
Visual Analogue Scale (VAS) ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome.
Time Frame
After 14 days of treatment
Title
Change from baseline in average Visual Analogic Scale score of subjects' perceptions of asthma symptoms after the first 7 days of treatment
Description
Visual Analogue Scale (VAS) ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome.
Time Frame
After the first 7 days of treatment
Title
Change from baseline in rescue medication use
Description
To be summarised on the "Intention To Treat" set by treatment group by descriptive statistics. Baseline value is defined as the average value (puffs/day) collected during the baseline period.
Time Frame
After 14 days of treatment
Title
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score
Description
There are 32 questions in the AQLQ that are divided in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). Answers are done on a 7-point scale (7 = not impaired at all - 1 = severely impaired), with higher scores indicating better quality of life.
Time Frame
After 14 days of treatment
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; autoimmune disorders Alcohol/drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Topole, MD
Organizational Affiliation
Chiesi Farmaceutici S.p.A.
Official's Role
Study Director
Facility Information:
Facility Name
Chiesi 38011
City
Bari
Country
Italy
Facility Name
Chiesi 38009
City
Battipaglia
Country
Italy
Facility Name
Chiesi 38006
City
Cagliari
Country
Italy
Facility Name
Chiesi 38010
City
Catanzaro
Country
Italy
Facility Name
Chiesi 38003
City
Genova
Country
Italy
Facility Name
Chiesi 38001
City
Milan
Country
Italy
Facility Name
Chiesi 38005
City
Napoli
Country
Italy
Facility Name
Chiesi 38004
City
Palermo
Country
Italy
Facility Name
Chiesi 38002
City
Roma
Country
Italy
Facility Name
Chiesi 38007
City
Sassari
Country
Italy

12. IPD Sharing Statement

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Study in Adult Patients With Moderate to Severe Asthma

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