Armonair Respiclick (fluticasone propionate MDPI) / Teva - LARVOL DELTA

Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Recruiting ➔ Completed | N=22 ➔ 30

Enrollment change • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

FDA Approvals Roundup: Kerendia, Padcev, Darzalex Faspro (Regulatory Affairs Professionals Society) - "ArmonAir RespiClick use expanded to children younger than 12 years: Teva’s ArmonAir RespiClick (fluticasone propionate inhalation powder) has been granted an extended approval as a maintenance treatment of asthma as prophylactic therapy in children aged 4 to 11 years. Approval for this younger population was based on findings from a multicenter, randomized, double-blind, placebo-controlled trial (Trial 3) in 841 children randomized 1:1 to the study drug (30 or 55 mcg) or placebo. The predefined endpoint was change from baseline in weekly average trough percent predicted forced expiratory volume in one second (ppFEV1) at 12 weeks."

sNDA • Asthma • Respiratory Diseases

Teva Canada Announces Availability of Aermony RespiClick, an Innovative New Device for the Treatment of Bronchial Asthma (Businesswire) - "Teva Canada... today announced product availability of Aermony RespiClick™, indicated for the maintenance treatment of steroid-responsive bronchial asthma as prophylactic therapy in patients 12 years of age and older and offered in a simple-to-use inhaler....Fluticasone propionate, the active ingredient in Aermony RespiClick...Aermony RespiClick™ will enter the market offering a price advantage compared to the branded fluticasone propionate inhalation powder and will come in three dose options..."

Launch Canada • Asthma

A Double Blind Open Label Comparator Study to Compare Treatments in 4 to 11 Year Old Patients With Asthma (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.

New P1 trial • Asthma • Biosimilar • Immunology

The Pharmacokinetics, Safety, and Tolerability of Single, High-Strength Doses of Fluticasone Propionate and Fluticasone Propionate/Salmeterol Delivered Via a Novel Multidose Dry Powder Inhaler in Adolescents and Adults with Persistent Asthma. (PubMed, J Asthma) - "Fp MDPI and FS MDPI produced similar or lower systemic exposure to Fp and salmeterol, despite lower doses, versus conventional DPI devices, suggesting improved efficiency due to formulation and device differences."

Journal

Randomized, double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older. (PubMed, J Asthma) - P3; "Pulmonary function was significantly improved with Fp MDPI and FS MDPI versus placebo and FS MDPI versus Fp MDPI. Active treatments had a safety profile comparable to placebo."

Clinical • Journal

Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (clinicaltrials.gov) - P3; N=841; Completed; Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.; Recruiting ➔ Completed

Clinical • Trial completion