Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder

NCT01738087 | Completed Phase 2

• 2 other identifiers: CCD-1205-PR-00872012-002370-30
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths. At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.

Conditions

Asthmatic

Keywords

patients; Adult

Outcome Measures

Primary Outcomes (1)

• Formoterol AUC0-t and B17MP AUC0-t

  from predose until 12 hr post dose

Secondary Outcomes (2)

• BDP pharmacokinetic (PK) parameters

  from predose until 12 hr post dose

• Other PK parameter of B17MP and formoterol

  from predose until 12 hours postdose

Other Outcomes (5)

• Plasma glucose

  from predose until 12 hours postdose

• Heart rate (HR)

  from predose until 12 hours postdose

• Plasma cortisol

  from predose until 24 hours postdose

Study Arms (6)

NEXThaler 100/6 mcg DPI

EXPERIMENTAL

Single dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg

Drug: NEXThaler 100/6 mcg DPI

NEXThaler 200/6 mcg DPI

EXPERIMENTAL

Single dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg

Drug: NEXThaler 200/6 mcg DPI

NEXThaler placebo

PLACEBO COMPARATOR

Single dose (4 inhalations)

Drug: NEXThaler placebo

NEXThaler 100/6 mcg plus CB

EXPERIMENTAL

Single dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg

Drug: NEXThaler 100/6 mcg DPI

NEXThaler 200/6 mcg plus CB

EXPERIMENTAL

Single dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg

Drug: NEXThaler 200/6 mcg DPI

Flixotide Accuhaler 500 mcg

ACTIVE COMPARATOR

Single dose (2 inhalations) of fluticasone propionate

Drug: Flixotide Accuhaler 500 mcg

Interventions

NEXThaler 100/6 mcg DPI DRUG

Also known as: Fixed combination of BDP plus formoterol fumarate

NEXThaler 100/6 mcg DPI; NEXThaler 100/6 mcg plus CB

Flixotide Accuhaler 500 mcg DRUG

Active comparator

Also known as: Fluticasone Propionate

Flixotide Accuhaler 500 mcg

NEXThaler 200/6 mcg DPI DRUG

Also known as: Fixed combination of BDP plus formoterol fumarate

NEXThaler 200/6 mcg DPI; NEXThaler 200/6 mcg plus CB

NEXThaler placebo DRUG

Placebo comparator

NEXThaler placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2011
• Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations.
• Patients with Forced Expiratory Volume in 1 sec (FEV1) \>= 70 % of predicted values
• Non or ex-smokers
• Body Mass Index (BMI) \>= 18.5 and \<= 32 kg/m2

You may not qualify if:

• Pregnant or lactating women unless using acceptable methods of contraception
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• History of near fatal asthma
• Patients with abnormal QTcF at screening Visit
• Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
• Lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
• History of drug addiction or excessive use of alcohol ;
• Diagnosis of restrictive lung disease.
• Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
• Significant medical history or any laboratory abnormality indicative of a significant underlying condition

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

The Medicine Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Related Links

• Study Record on EU Clinical Trials Register including results
• CSR Synopsis available in the CHIESI Clinical Study Register

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate; Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 30, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

GB (1)