Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old

NCT02787967 | Completed Phase 2

• 2 other identifiers: CCD-01535BB1-012015-005152-10
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP

  B17MP: Profile of Pharmacokinetics

  predose, 15,30min, 1,2,4,6,8 hours post dose

Secondary Outcomes (15)

• B17MP Cmax

  predose, 15min,30min,1,2,4,6,8 hours post dose

• BDP Area Under Curve (AUC)

  predose, 15min,30min,1,2,4,6,8 hours post dose

• Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 [

  predose, 15min, 30 min, 1,2,4,6,8 hours postdose

• Formoterol Cmax

  predose, 15min, 30 min, 1,2,4,6,8 hours postdose

• Formoterol Tmax

  predose, 15min, 30 min, 1,2,4,6,8 hours postdose

Study Arms (2)

NEXThaler® 35/4µg

EXPERIMENTAL

CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations. Total Dose: BDP 200µg FF 16µg

Drug: CHF 1535 35/4µg NEXThaler®

Reference treatment

ACTIVE COMPARATOR

Drug: free comb. beclomethasone DPI and formoterol DPI 2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg

Drug: free comb. beclomethasone DPI and formoterol DPI

Interventions

CHF 1535 35/4µg NEXThaler® DRUG

4 (four) inhalations (total dose: BDP/FF 140/16 µg)

NEXThaler® 35/4µg

free comb. beclomethasone DPI and formoterol DPI DRUG

2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg

Reference treatment

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male/female children with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
• Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.
• Age ≥ 5 \< 12 years (8 to 10 children in the age range 5-8 years old).
• Children with a forced expiratory volume in one second (FEV1)\>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
• A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures

You may not qualify if:

• Past or present diagnosis of cardiovascular, renal or liver disease.
• Known hypersensitivity to the active treatmen
• Exacerbation of asthma symptoms within 4 weeks prior to screening.
• Inability to perform the required breathing technique and blood sampling.
• Hospitalization due to exacerbation of asthma within 1 month prior to screening (Visit 1).
• Lower respiratory tract infection within 1 month prior to screening (Visit 1).
• Disease (other than asthma) which might influence the outcome of the study.
• Obesity, i.e. \> 97% weight percentile by local standards

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

BørneAstmaKlinikken, Hans Knudsens Plads 1A,

Copenhagen, Denmark

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Hans Bisgaard, MD

  Copenhagen Studies on Asthma in Childhood

  PRINCIPAL INVESTIGATOR

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: March 15, 2016
• First Posted: June 2, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)