Study in Adult Patients With Moderate to Severe Asthma

NCT04886999 | Completed Phase 3 Results

• 2 other identifiers: CLI-01535AA0-022021-001449-11
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 10

Brief 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 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.

Conditions

Asthma

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)

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (24)

• Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #4

  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

  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

  Baseline and Treatment Day 14 within each treatment period

Study Arms (2)

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.

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.

Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A); Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)

Interventions

Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A) DRUG

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.

Also known as: CHF1535 100/6 µg pMDI

Sequence Inhaler A - Inhaler B (Period 1); Sequence Inhaler B - Inhaler A (Period 2)

Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B) DRUG

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.

Also known as: CHF1535 100/6 µg pMDI

Sequence Inhaler A - Inhaler B (Period 1); Sequence Inhaler B - Inhaler A (Period 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (10)

Chiesi Clinical Trial Site 38011

Bari, Italy

Location

Chiesi Clinical Trial Site 38009

Battipaglia, Italy

Location

Chiesi Clinical Trial Site 38006

Cagliari, Italy

Location

Chiesi Clinical Trial Site 38010

Catanzaro, Italy

Location

Chiesi Clinical Trial Site 38003

Genova, Italy

Location

Chiesi Clinical Trial Site 38001

Milan, Italy

Location

Chiesi Clinical Trial Site 38005

Naples, Italy

Location

Chiesi Clinical Trial Site 38004

Palermo, Italy

Location

Chiesi Clinical Trial Site 38002

Roma, Italy

Location

Chiesi Clinical Trial Site 38007

Sassari, Italy

Location

Related Publications (1)

• 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.

  PMID: 39772981 BACKGROUND

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Clinical Trial INFO
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+39 0521 2791

Study Officials

• Eva Topole, MD

  Chiesi Farmaceutici S.p.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 14, 2021
• Study Start: February 24, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)