Single-Dose Clinical Pharmacology Study in Asthmatic Adolescent and Adult Patients

NCT01803087 | Completed Phase 2

• 1 other identifier: CCD-1104-PR-0062
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products; this will be additionally compared to the systemic exposure in adults without the spacer device.

Conditions

Asthma

Keywords

adolescents; adults

Outcome Measures

Primary Outcomes (1)

• AUC0-t of B17MP CHF 1535 100/6 pMDI with and without spacer vs free combination of BDP pMDI and formoterol pMDI

  In adolescents, the systemic exposure of B17MP as AUC0-t, after inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) vs already licensed free combination of BDP pMDI and formoterol pMDI without spacer.

  : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.

Secondary Outcomes (5)

• AUC0-t, AUC0-inf, Cmax, tmax and t½ for BDP and formoterol

  : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.

• AUC0-0.5h, AUC0-inf, Cmax, tmax and t½ for B17MP

  : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.

• plasma glucose and plasma potassium AUC0-t; Cmin; Tmin; Cmax; Tmax

  : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.

• Heart rate as AUC0-8h of CHF 1535 100/6 pMDI

  pre-dose (within 5 min from dosing), 5 min; 10 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.

• FEV1; time everaged FEV1 value AUC0-8h; peak FEV1

  pre-dose; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.

Study Arms (4)

CHF 1535 100/6 pMDI (Foster®) TEST 1

ACTIVE COMPARATOR

Adolescents CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI

Drug: Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1

CHF 1535 100/6 pMDI (Foster®) AeroChamber Plus™ (TEST 2).

ACTIVE COMPARATOR

CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ spacer device in adolescents (TEST 2)

Drug: CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2).

(Qvar®: BDP 400 µg)+(Atimos®: formoterol 24 µg)

ACTIVE COMPARATOR

BDP 100 µg pMDI, 4 puffs (Qvar®, total dose: BDP 400 µg) + formoterol fumarate 6 µg pMDI, 4 puffs (Atimos®, total dose: formoterol 24 µg)

Drug: BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF)

CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI

ACTIVE COMPARATOR

Adults CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI

Drug: CHF 1535 100/6 pMDI (Foster®) (CTR)

Interventions

Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1 DRUG

CHF 1535 100/6 pMDI (Foster®) TEST 1

CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2). DRUG

CHF 1535 100/6 pMDI (Foster®) AeroChamber Plus™ (TEST 2).

BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF) DRUG

Also known as: Free combination of BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) in adolescents (REF)

(Qvar®: BDP 400 µg)+(Atimos®: formoterol 24 µg)

CHF 1535 100/6 pMDI (Foster®) (CTR) DRUG

Also known as: CHF 1535 100/6 pMDI (Foster®) in adults (CTR)

CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients will be enrolled if they meet all of the following criteria:
• Male and female adolescents, aged ≥ 12 and \< 18 years at the time of Screening Visit or male and female adults, aged ≥ 18 and ≤ 65 years at the time of Screening Visit.
• Written informed consent obtained by the patient in case of adult patients and by parents/legal representative and by the minor (according to local regulation).
• A diagnosis of asthma as defined in the GINA guidelines (updated 2010) 6 months before the screening visit.
• Male/female adolescent and adult patients with asthma stable enough, according to GINA guidelines (updated 2010) and based on the Investigator's opinion, to allow a wash out period from inhaled BDP of 2 days before each single day study treatments and any ICS other than BDP of 1 day before each single day study treatments.
• Male/female adolescents and adults asthmatic patients already treated with ICS or ICS/long-acting inhaled β2-agonists or using short-acting inhaled β2-agonists as reliever to control asthma symptoms.
• Adolescents and adults with a forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding short acting β2-agonist treatment for a minimum of 6 h prior to screening or 24 hours in case of long acting β2-agonist.
• Non- or ex-smokers who smoked less than 5 pack-years (e.g. \< 20 cigarettes per day for 5 years) and stopped smoking for at least 1 year.
• A cooperative attitude and ability to be trained about the proper use of pMDI with and without a spacer device and compliant to study procedures.
• Body mass index (BMI) ≥18.5 and ≤ 32 kg/m2

You may not qualify if:

• Patients will not be enrolled if one or more of the following criteria are present:
• Pregnant or breast-feeding female patients. Sexually active female not using efficient contraception throughout the entire study period (e.g. oestro-progestatives, condoms, intrauterine devices). A urinary pregnancy test will be performed at screening and treatment visits (mandatory in the adult population and at discretion of the investigator in the adolescent population) in women of childbearing potential;
• Having received an investigational drug within 2 months before the screening visit (Visit 1).
• Diagnosis of COPD, in the adult patients, as defined by the current GOLD guidelines (updated 2010).
• Known hypersensitivity to the active treatments.
• Inability to perform the required breathing technique and blood sampling.
• Hospitalization due to exacerbation of asthma within 1 month prior to the screening visit.
• Lower respiratory tract infection within 1 month prior to screening visit.
• Obesity, i.e. \> 97% weight percentile by local standards.
• Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, that may interfere with patient's safety, compliance, or study evaluations, according to the Investigator's opinion;
• History of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units alcohol; one unit being a glass of beer, wine or a measure of spirits), or excessive consumption of xanthine containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc) or psychological or other emotional problems likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements;
• Treatment with a xanthine derivative (e.g. theophylline) formulations in the 4 weeks prior to screening;
• Blood donation (450 mL or more) (for the adult population) or significant blood loss in the 12 weeks before the screening visit.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Uniwersytecki Szpital Kliniczny nr 1

Lodz, 90153, Poland

Location

Related Publications (1)

• Kuna P, Govoni M, Lucci G, Scuri M, Acerbi D, Stelmach I. Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma. Br J Clin Pharmacol. 2015 Sep;80(3):569-80. doi: 10.1111/bcp.12640. Epub 2015 Jun 1.

  PMID: 25808292 RESULT

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma

Interventions

Foster Home Care; Beclomethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

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: October 4, 2012
• First Posted: March 4, 2013
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

PL (1)