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AsthmaPhase 2ADO pMDINCT01803087

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

A Phase 2 study testing Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1, CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2). and BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF) in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Asthma
What is being tested?
Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1, CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2). and BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePoland
Study dates
Feb 2012to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Uniwersytecki Szpital Kliniczny nr 1

    Lodz, 90153

Other trials in Poland

About this study

Official title: A SINGLE-DOSE, OPEN LABEL, RANDOMIZED, 3-WAY CROSSOVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 100/6 pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg) WITH OR WITHOUT SPACER DEVICE VERSUS THE FREE COMBINATION OF LICENSED BECLOMETHASONE pMDI AND FORMOTEROL pMDI IN ASTHMATIC ADOLESCENT PATIENTS AND ONE OPEN ARM FOR ADULT PATIENTS AS CONTROL GROUP TREATED WITH CHF 1535 100/6 pMDI.

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.

Read the detailed description

The proposed clinical pharmacology study is aimed to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI (to reach a total dose of BDP 400 µg and formoterol 24 µg) with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products (to reach the same total dose of BDP and formoterol) in adolescent asthmatic patients. The systemic exposure to BDP/B17MP and formoterol after inhalation of CHF 1535 pMDI in adolescents will be additionally compared to the systemic exposure in adults without the spacer device.

The chosen doses correspond to the maximum daily dose of the two components administered as fixed combination.

Conditions
Asthma
Being tested
Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1, CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2)., BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF), CHF 1535 100/6 pMDI (Foster®) (CTR)
Keywords
adolescents, adults
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1Drug

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

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

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

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

    Also called CHF 1535 100/6 pMDI (Foster®) in adults (CTR)

Study groups in NCT01803087
Study groupRoleWhat they receive
CHF 1535 100/6 pMDI (Foster®) TEST 1Active comparatorAdolescents CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI
Receives: Drug: Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1
CHF 1535 100/6 pMDI (Foster®) AeroChamber Plus™ (TEST 2).Active comparatorCHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ spacer device in adolescents (TEST 2)
Receives: Drug: CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2).
(Qvar®: BDP 400 µg)+(Atimos®: formoterol 24 µg)Active comparatorBDP 100 µg pMDI, 4 puffs (Qvar®, total dose: BDP 400 µg) + formoterol fumarate 6 µg pMDI, 4 puffs (Atimos®, total dose: formoterol 24 µg)
Receives: 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) pMDIActive comparatorAdults CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI
Receives: Drug: CHF 1535 100/6 pMDI (Foster®) (CTR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: : 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)

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

    In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs a free combination of licensed BDP and Formoterol pMDIs.

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

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

    In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs a free combination of licensed BDP and Formoterol pMDIs.

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

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

    In adolescents, after inhalation of CHF 1535 100/6 pMDI with and without spacer (AeroChamber Plus™)vs fre combination

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

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

    In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs free combination

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

  5. FEV1; time everaged FEV1 value AUC0-8h; peak FEV1

    In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs a free combination of licensed BDP and Formoterol pMDIs.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2013 (estimated)
  2. Study startFeb 2012
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01803087
Sponsor's protocol ID
CCD-1104-PR-0062
Acronym
ADO pMDI
Status last verified
Jul 2020
First submitted
4 Oct 2012
Last updated
31 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25808292

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1, CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2). and BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF) in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-t of B17MP CHF 1535 100/6 pMDI with and without spacer vs free combination of BDP pMDI and formoterol pMDI (time frame: : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01803087, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.

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