Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Fluticasone Propionate/Salmeterol; Drug: Placebo MDPI; Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02980133

2016-003835-39 (EudraCT Number)

FSS-AS-30003

Details and patient eligibility

About

This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma.

Enrollment: 841 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant has a diagnosis of asthma as defined by the National Institutes of Health (NIH).

• The participant has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for age, height, sex, and race at the screening visit (SV).

• The participant's persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV. Participants currently on a short-acting β2-agonist (SABA) only, regimen or as needed (PRN), are not eligible.

• The participant has demonstrated ≥10% response to a bronchodilator from screening FEV1 within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol.

• The participant (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device.

• All participants must be able to replace their current SABA with albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) inhalation aerosol at the SV for use as needed for the duration of the study.

  • Additional criteria apply, please contact the investigator for more information

Exclusion criteria

• The participant has a history of life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.

• The participant is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the participant's last study-related visit.

• The participant has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the investigational medicinal product (IMP) or rescue medication formulation (that is, lactose).

• The participant has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (for example, ketoconazole, ritonavir, clarithromycin) within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study.

• The participant currently smokes or has a smoking history. The participant must not have used tobacco products within the past year (for example, cigarettes, cigars, chewing tobacco, or pipe tobacco).

• The participant has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV or has had any hospitalization for asthma within 2 months before the SV.

• The participant has used immunosuppressive medications within 30 days before the SV.

• The participant has untreated oral candidiasis at the SV. Participants with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the run-in period.

• The participant has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection.

• The participant is an immediate relative of an employee of the clinical investigational center.

• A member of the participant's household is participating in the study at the same time.

• Vulnerable participants (that is, people kept in detention) are excluded from participation.

  • Additional criteria apply, please contact the investigator for more information

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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841 participants in 4 patient groups, including a placebo group

Placebo MDPI

Placebo Comparator group

Description:

Participants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks.

Treatment:

Drug: Placebo MDPI

Fp MDPI 25 mcg BID

Experimental group

Description:

Participants received 1 inhalation of 25 mcg fluticasone propionate (Fp) via MDPI twice daily (BID) (total daily dose: 50 mcg) for 12 weeks.

Treatment:

Drug: Fluticasone Propionate

Fp MDPI 50 mcg BID

Experimental group

Description:

Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.

Treatment:

Drug: Fluticasone Propionate

FS MDPI 50/12.5 mcg BID

Experimental group

Description:

Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol (FS) via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.

Treatment:

Drug: Fluticasone Propionate/Salmeterol