Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old

NCT01848769 | Completed Phase 2

• 1 other identifier: CCD-0902-PR-0013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).

Conditions

Asthma

Keywords

Asthma; ICS+LABA; Children; Inhalation; pMDI

Outcome Measures

Primary Outcomes (1)

• B17MP AUC0-t

  B17MP (active metabolite of BDP) systemic exposure as AUC0-t

  pre-dose until 8hours post dose

Secondary Outcomes (8)

• B17MP PK profile

  pre-dose until 8 hours post-dose

• BDP PK prolile

  Pre-dose until 8 hours post-dose

• Formoterol PK profile

  Pre-dose until 8 hours post-dose

• Plasma potassium AUC, Cmin, tmin

  Pre-dose until 8 hours post-dose

• Urinary Cortisol excretion

  Pre-dose until 8 hours post-dose

Study Arms (2)

CHF1535 pMDI + AC Plus

EXPERIMENTAL

Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device

Drug: CHF1535 pMDI + AC Plus

BDP and Formoterol + AC Plus

ACTIVE COMPARATOR

Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device

Drug: BDP + AC Plus; Drug: Formoterol + AC Plus

Interventions

CHF1535 pMDI + AC Plus DRUG

Four inhalations for a total dose of BDP/FF 200/24 mcg

Also known as: Fixed combination of BDP and FF 50/6 mcg

CHF1535 pMDI + AC Plus

BDP + AC Plus DRUG

Four inhalations for a total dose of BDP 200 mcg

Also known as: Beclomethasone Dipropionate 50 mcg with Aerochamber Plus

BDP and Formoterol + AC Plus

Formoterol + AC Plus DRUG

Four inhalations for a total dose of Formoterol 24 mcg

Also known as: Formoterol 6 mcg with Aerochamebr Plus

BDP and Formoterol + AC Plus

Eligibility Criteria

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

You may qualify if:

• Male/Female children aged 5-11 years
• Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
• children with stable asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
• Forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period.
• \. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.

You may not qualify if:

• Past or present diagnoses of cardiovascular, renal or liver disease
• Known hypersensitivity to the active treatments
• Exacerbation of asthma symptoms within the previous 4 weeks
• Inability to perform the required breathing technique and blood sampling
• 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)

BorneAstmaKlinikken

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16.

  PMID: 24746942 BACKGROUND

• Chawes BL, Piccinno A, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Sergio F, Ciurlia G, Poli G, Acerbi D, Bisgaard H. Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children. Br J Clin Pharmacol. 2013 Apr;75(4):1081-8. doi: 10.1111/j.1365-2125.2012.04459.x.

  PMID: 22978252 RESULT

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma; Respiratory Aspiration

Interventions

alpha-ketoisovalerate dehydrogenase phosphatase; Beclomethasone; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Hans Bisgaard, MD DMSci

  BorneAstmaKlinikken

  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: May 3, 2013
• First Posted: May 7, 2013
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

DK (1)