A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TACROLIMUS MDI AS ADD-ON THERAPY TO ICS AND LABA

INTERVENTION: Product Name: Tacrolimus Inhalation Aerosol Product Code: FK506 Pharmaceutical Form: Pressurised inhalation, solution INN or Proposed INN: Tacrolimus CAS Number: 104987‐11‐3 Current Sponsor code: FK506 Concentration unit: % percent Concentration type: equal Concentration number: 0.05‐ Pharmaceutical form of the placebo: Pressurised inhalation, solution Route of administration of the placebo: Inhalation use Product Name: Tacrolimus Inhalation Aerosol Product Code: FK506 Pharmaceutical Form: Pressurised inhalation, solution INN or Proposed INN: Tacrolimus CAS Number: 104987‐11‐3 Current Sponsor code: FK506 Concentration unit: % percent Concentration type: equal Concentration number: 0.1‐ Pharmaceutical form of the placebo: Pressurised inhalation, solution Route of administration of the placebo: Inhalation use Trade Name: SERETIDE 25/125 INHALER inh. sus. pss. Product Name: SERETIDE 25/125 INHALER inh. sus. pss. Pharmaceutical Form: Pressurised inhalation, suspension INN or Proposed INN: Salmeterol CAS Number: 89365‐50‐4 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 25‐ INN or Proposed INN: Fluticasone CAS Number: 90566‐53‐3 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 125‐ CONDITION: Asthma ; MedDRA version: 7.0 Level: LLT Classification code 10003553 PRIMARY OUTCOME: Main Objective: To assess the efficacy of inhaled tacrolimus as add‐on therapy to an inhaled reference corticosteroid (ICS) in combination with a long‐acting beta‐2‐agonist (LABA) in patients with moderate to severe persistent asthma. ICS+LABA+50 µg tacrolimus BID and ICS+LABA+100 µg tacrolimus BID will be compared (combined and separate) to ICS+LABA+placebo BID. Primary end point(s): The primary endpoint is the absolute change in patient's maximum value of FEV1 from baseline (day 1) to day 84 / end of treatment. Secondary Objective: To investigate efficacy and safety of the two inhaled tacrolimus doses. ; To obtain tacrolimus blood levels in this asthma population. INCLUSION CRITERIA: Inclusion criteria in general 1. Male or female asthmatic patients between 18 to 70 years of age, inclusive 2. Patients must have a diagnosis of asthma for at least 12 months 3. Patients pre‐treated with ICS for at least 3 months prior to study entry (inhaled daily ICS doses of 800 to 1600 µg budesonide, 1000 to 2000 µg beclomethasone, 500 to 1000 µg fluticasone, 800 to 1600 µg mometasone or equivalent doses of other ICS) and 4. Patients pre‐treated with LABAs (formoterol or salmeterol) for at least 3 months prior to study entry or (alternative to inclusion criteria 3. and 4.) 5. Patients pre‐treated with ICS and LABA in fixed combination for at least 3 months prior to study entry 6. Patients not well controlled on ICS and LABA, i.e. some asthma symptoms still occurring: ‐ additional usage of an inhaled short‐acting beta‐2‐agonist, or ‐ daily asthma symptoms or

Epistemonikos ID: 5dfc38c076a497a4432d9d37acb15af2464863c1
First added on: Aug 21, 2024