NCT02676076

Brief Summary

The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,153

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Feb 2016

Typical duration for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

February 17, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2018

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

February 3, 2016

Last Update Submit

April 6, 2021

Conditions

Asthma

Keywords

asthma, anticholinergics, triple combination

Outcome Measures

Primary Outcomes (2)

  • Pre-dose FEV1 (Forced Expiratory Volume in the first second)

    at Week 26

  • Reduction of moderate and severe asthma exacerbations rate

    Week 0 to Week 52

Secondary Outcomes (3)

  • Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose

    at Week 26

  • Change from baseline in morning PEF (Peak Expiratory Flow)

    Week 0 to Week 26

  • Reduction of severe asthma exacerbations rate

    Week 0 to Week 52

Other Outcomes (2)

  • Adverse Events and Adverse Drug reactions

    Up to Week 52

  • Collection of Health Economics outcomes

    Week 0 to Week 52

Study Arms (2)

CHF 5993 100/6/12.5 µg

EXPERIMENTAL

Treatment A: CHF 5993 100/6/12.5 µg: 2 inhalations bid Total daily dose: 400/24/50 µg BDP/FF/GB

Drug: CHF 5993 100/6/12.5 µg

CHF 1535 100/6 µg

ACTIVE COMPARATOR

Treatment B : CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF

Drug: CHF 1535 100/6 µg

Interventions

CHF 5993 100/6/12.5 µgDRUG
CHF 5993 100/6/12.5 µg
CHF 1535 100/6 µgDRUG
CHF 1535 100/6 µg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of asthma ≥ 1 year and diagnosed before 40 years old
  • Uncontrolled asthma with double therapy only on medium doses of Inhaled CorticoSteroid (ICS) in combination with Long-acting beta2 Agonist (LABA) with ACQ-7 (Asthma Control Questionnaire) ≥1.5
  • Pre-bronchodilator FEV1 \<80% of the predicted normal value
  • Positive reversibility test
  • At least 1 documented asthma exacerbation in the previous year

You may not qualify if:

  • Pregnant or lactating women
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior screening
  • Current or ex-smokers (\>= 10 packs year)
  • Any change in dose, schedule or formulation of ICS + LABA combination in the 4 weeks prior screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiesi Clinical Trial Site 276814

Rostock, Germany

Location

Related Publications (6)

  • Virchow JC, Kuna P, Paggiaro P, Papi A, Singh D, Corre S, Zuccaro F, Vele A, Kots M, Georges G, Petruzzelli S, Canonica GW. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019 Nov 9;394(10210):1737-1749. doi: 10.1016/S0140-6736(19)32215-9. Epub 2019 Sep 30.

    PMID: 31582314RESULT

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PMID: 36472162DERIVED

  • Orlovic M, Magni T, Lukyanov V, Guerra I, Madoni A. Cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium in patients with uncontrolled asthma in England. Respir Med. 2022 Sep;201:106934. doi: 10.1016/j.rmed.2022.106934. Epub 2022 Jul 19.

    PMID: 35872377DERIVED

  • Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.

    PMID: 35450196DERIVED

  • Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER. Respir Res. 2020 Oct 29;21(1):285. doi: 10.1186/s12931-020-01558-y.

    PMID: 33121501DERIVED

  • Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Extrafine triple therapy in patients with asthma and persistent airflow limitation. Eur Respir J. 2020 Sep 24;56(3):2000476. doi: 10.1183/13993003.00476-2020. Print 2020 Sep. No abstract available.

    PMID: 32430414DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Christian Virchow, MD

    Facharzt für Innere Medizin Rostock, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 8, 2016

Study Start

February 17, 2016

Primary Completion

May 17, 2018

Study Completion

May 17, 2018

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Access Criteria
Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
More information

Locations

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