Fluticasone propionate; Salbutamol sulfate for Asthma

Inclusion criteria

• {"criterion_text":"- a.\tThe patient is capable of giving signed informed consent (age ≥18 years). Patients ages 4 to <18 years (or as applicable and required by local regulation) are able to provide assent and written consent must be provided by a parent/legally acceptable representative before any study procedures are performed."}
• {"criterion_text":"- b.\tThe patient is a male or female 4 years of age or older at the time of informed consent/assent or age as allowed by local regulation."}
• {"criterion_text":"- c.\tThe patient has a documented diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines."}
• {"criterion_text":"- d.\tThe patient has an ACQ-5 score of ≥1.5 at the screening visit. (Patients aged 4-5 years are not required to meet this criteria)."}
• {"criterion_text":"- e.\tThe patient has a documented history of at least 1 severe CAE ending within the past 12 month."}
• {"criterion_text":"- f.\tThe patient is using any prescribed inhaled asthma controller medication (at a stable dose for 1 month prior to the screening visit)."}
• {"criterion_text":"- g.\tPatients aged 18 years and older must have a screening (V1) prebronchodilator FEV1 of ≥40 to <90% predicted normal value. Patients aged 4 to 17 years at the time of screening must have an FEV1 of ≥60% predicted normal value (Quanjer et al 2012) after withholding specified medications including SABA (rescue medication) for spirometry testing. Patients are not required to meet these criteria at V3. Patients failing to meet these criteria are allowed a single additional retest during the screening period in advance of the second visit."}

Exclusion criteria

• {"criterion_text":"- a.\tThe patient has any asthma worsening requiring a change in asthma treatment other than SABA and/or short-acting anticholinergic agent within 30 days prior to screening or during the run-in period."}
• {"criterion_text":"- j.\tThe patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis,pulmonary fibrosis), or participants with a diagnosis of asthma COPD overlap syndrome (ACOS)."}
• {"criterion_text":"- k.\tThe patient is a current smoker and/or has a history of ≥10 pack – years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months or any orally inhaled products including but not limited to cigarettes, beedis vaping, e-cigarettes, hookah/waterpipes or marijuana. Note: participants with a positive urinary cotinine test will be excluded."}
• {"criterion_text":"- b.\tThe patient has life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years before screening."}
• {"criterion_text":"- c.\tThe patient has a suspected bacterial or viral infection (other than Coronavirus Disease [COVID-19]) of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period."}
• {"criterion_text":"- d.\tPatients with a confirmed infection with COVID-19 within 6 weeks prior to the screening visit, or with residual COVID-19 symptoms (\"long COVID-19”)."}
• {"criterion_text":"- e.\tPatients with clinical symptoms that may indicate COVID-19 infection."}
• {"criterion_text":"- f.\tThe patient is currently being treated with a prohibited medication (Appendix G) including SCS or biological medications used to treat asthma or malignancy."}
• {"criterion_text":"- g.\tThe patient has cancer not in complete remission for at least 5 years."}
• {"criterion_text":"- h.\tThe patient has had a CAE requiring systemic corticosteroids within 30 days before screening, or any hospitalization for asthma within 2 months before screening."}
• {"criterion_text":"- i.\tThe patient has used SCS (any dose and any indication) within 30 days prior to screening."}

Primary endpoints

• {"endpoint_text":"- Time to first severe CAE with HD Fp/ABS eMDPI.","definition_or_measurement_approach":"Time from randomization to the first occurrence of a severe clinical asthma exacerbation (CAE) while using high-dose (HD) fluticasone propionate/albuterol sulfate eMDPI as rescue medication (as described in the primary objective)."}

Secondary endpoints

• {"endpoint_text":"- The key efficacy endpoints: - annualized severe CAE rate '- total annualized SCS exposure over the treatment period","definition_or_measurement_approach":"Key efficacy endpoints are (1) annualized rate of severe clinical asthma exacerbations (CAE) and (2) total annualized systemic corticosteroid (SCS) exposure during the treatment period (as stated in the secondary objectives)."}
• {"endpoint_text":"- Asthma Control Questionnaire-5 (ACQ-5) response at week 24, defined as achieving a decrease in score from baseline value of at least 0.5","definition_or_measurement_approach":"Responder defined as ≥0.5 decrease from baseline ACQ-5 at Week 24."}
• {"endpoint_text":"- Asthma Quality of Life Questionnaire + 12 (AQLQ+12) response at week 24, defined as achieving an increase from baseline of at least 0.5","definition_or_measurement_approach":"Responder defined as ≥0.5 increase from baseline AQLQ+12 (or pediatric equivalent PAQLQ) at Week 24."}
• {"endpoint_text":"- Safety/Tolerability endpoints: '- occurrence of adverse events during the study '- occurrence of serious adverse events during the study '- study withdrawal due to treatment-emergent adverse events","definition_or_measurement_approach":"Standard safety endpoints capturing incidence of adverse events (AEs), serious adverse events (SAEs), and withdrawals due to treatment-emergent AEs during the study period."}
• {"endpoint_text":"- Time to first severe CAE with LD Fp/ABS eMDPI","definition_or_measurement_approach":"Time from randomization to first severe CAE while using low-dose (LD) fluticasone propionate/albuterol sulfate eMDPI as rescue medication."}

Methods

• Printed patient and caregiver brochures and posters distributed in clinics (multilingual patient/caregiver brochures and posters targeted at patients and parents/legal guardians).
• Digital recruitment: social media ads, Google Ads, website informational pages and website images (multilingual; country-specific language variants provided).
• Healthcare professional outreach: GP letters and doctor-to-doctor (Dr-to-Dr) emails to clinicians to notify about the study and refer eligible patients.
• Mass media: radio advertisement scripts and print advertisements targeted to the general public in participating regions.
• Direct contact: phone scripts for site staff to contact potential participants.
• Study listings/clinical trial listing materials for public registries/webpages to inform patients and carers in participating countries.
• Site-based recruitment using site databases and local clinic patient lists (site-specific approaches described in recruitment arrangements).

Germany

Earliest CTIS Part Ii Submission Date

11-04-2024

Latest Decision Or Authorization Date

16-04-2024

Processing Time Days

5

Number Of Sites

21

Number Of Participants

150

Bulgaria

Earliest CTIS Part Ii Submission Date

05-03-2024

Latest Decision Or Authorization Date

01-04-2024

Processing Time Days

27

Number Of Sites

16

Number Of Participants

175

Denmark

Earliest CTIS Part Ii Submission Date

08-07-2024

Latest Decision Or Authorization Date

16-07-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

27

Poland

Earliest CTIS Part Ii Submission Date

04-03-2024

Latest Decision Or Authorization Date

25-03-2024

Processing Time Days

21

Number Of Sites

15

Number Of Participants

190

Spain

Earliest CTIS Part Ii Submission Date

29-01-2024

Latest Decision Or Authorization Date

22-03-2024

Processing Time Days

53

Number Of Sites

7

Number Of Participants

45

Czechia

Earliest CTIS Part Ii Submission Date

26-01-2024

Latest Decision Or Authorization Date

28-03-2024

Processing Time Days

62

Number Of Sites

8

Number Of Participants

55

Slovakia

Earliest CTIS Part Ii Submission Date

05-03-2024

Latest Decision Or Authorization Date

19-03-2024

Processing Time Days

14

Number Of Sites

6

Number Of Participants

40

Romania

Earliest CTIS Part Ii Submission Date

21-06-2024

Latest Decision Or Authorization Date

23-09-2024

Processing Time Days

94

Number Of Sites

6

Number Of Participants

97

Hungary

Earliest CTIS Part Ii Submission Date

02-02-2024

Latest Decision Or Authorization Date

26-03-2024

Processing Time Days

53

Number Of Sites

5

Number Of Participants

95

Italy

Earliest CTIS Part Ii Submission Date

24-06-2024

Latest Decision Or Authorization Date

13-09-2024

Processing Time Days

81

Number Of Sites

4

Number Of Participants

6

Greece

Earliest CTIS Part Ii Submission Date

12-07-2024

Latest Decision Or Authorization Date

12-09-2024

Processing Time Days

62

Number Of Sites

5

Number Of Participants

25

Latvia

Earliest CTIS Part Ii Submission Date

29-02-2024

Latest Decision Or Authorization Date

27-03-2024

Processing Time Days

27

Number Of Sites

8

Number Of Participants

95

Primary sponsor

Full Name

Teva Branded Pharmaceutical Products R&D LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Pharmaceutical Product Development LLC

Responsibilities

CRO services (sponsorDuties code 4 listed)

Name

Syneos Health Netherlands B.V.

Responsibilities

Operational trial management and multiple study support roles

Name

Syneos Health Hellas Single Member S.A.

Responsibilities

Local operational support and study services

Third parties

• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Codes/roles: 1,11,12,13,2,5,6,7,8 (multiple operational and project roles listed in Part II)","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Syneos Health Hellas Single Member S.A.","duties_or_roles":"Codes/roles: 1,12,3,6,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA, Spirometry and Cardiac Services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Yourway Transport Inc.","duties_or_roles":"Inhaler data extraction","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Packaging labeling and distribution (codes 14, 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Label text and Artwork Approvals, Label Translations Country Approvals/Regulatory","organisation_type":"Pharmaceutical company"}