NCT01345916

Brief Summary

The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
932

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Mar 2011

Shorter than P25 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

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

April 12, 2011

Last Update Submit

March 28, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow.

    at 8 weeks

Secondary Outcomes (8)

  • Pre-dose morning FEV1 (Forced Expiratory Volume in one second);

    at 2, 4, 6 and 8 weeks of treatment

  • Pre-dose morning FVC (Force Vital Capacity) ;

    at 2, 4, 6 and 8 weeks of treatment

  • ACQ (Asthma Control Questionnaire) score ;

    at eight weeks

  • pre-dose evening PEF ;

    at 2, 4, 6 and 8 weeks of treatment

  • daily PEF variability ;

    at 2, 4, 6 and 8 weeks of treatment

  • +3 more secondary outcomes

Study Arms (3)

CHF 1535 100/6 NEXT Dry Powder Inhaler®

EXPERIMENTAL

CHF1535 100/6 NEXT DPI® 1 inhalation bis in day (b.i.d) (daily dose BDP 200/FF 12 µg)

Drug: CHF 1535 100/6 NEXT DPI® 2 months

CHF1535 100/6 pMDI

ACTIVE COMPARATOR

CHF1535 100/6 pressurisedMeterDoseInhaler 1 inhalation b.i.d (total daily dose BDP 200/FF 12 µg)

Drug: CHF 1535 100/6 pMDI 2 months

beclomethasone dipropionate DPI

ACTIVE COMPARATOR

beclomethasone dipropionate 100 µg DPI, 1 inhalation b.i.d (total daily dose BDP 200 µg)

Drug: BDP DPI 2 months

Interventions

CHF 1535 100/6 NEXT DPI® 2 monthsDRUG

CHF 1535 100/6 NEXT DPI® 2 months

CHF 1535 100/6 NEXT Dry Powder Inhaler®
CHF 1535 100/6 pMDI 2 monthsDRUG

CHF 1535 100/6 pMDI 2 months

Also known as: Foster®
CHF1535 100/6 pMDI
BDP DPI 2 monthsDRUG

BDP DPI 2 months

Also known as: Clenil® Pulvinal®
beclomethasone dipropionate DPI

Eligibility Criteria

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

You may qualify if:

  • Male and female adults (≥18 years old).
  • Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL .
  • FEV1 \> 80% of the predicted values .
  • Asthma Control Questionnaire score \< 1.25.
  • Asthmatic patients
  • Non- or ex-smokers

You may not qualify if:

  • History of near fatal asthma.
  • COPD patients
  • Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period.
  • Lower respiratory tract infection within 1 month prior Visit1 (V1).
  • History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
  • Diagnosis of restrictive lung disease.
  • Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1
  • Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
  • Significant medical history of and/or treatments
  • Active cancer or a history of cancer .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSPZOZ Uniwersytecki Szpital Kliniczny

Lodz, 90-153, Poland

Location

Related Publications (1)

  • Kanniess F, Scuri M, Vezzoli S, Francisco C, Petruzzelli S. Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler((R))) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, double-blind trial. Pulm Pharmacol Ther. 2015 Feb;30:121-7. doi: 10.1016/j.pupt.2014.07.006. Epub 2014 Aug 1.

    PMID: 25088067RESULT

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Foster Home Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Frank KANNIESS, Dr

    Gemeinschaftspraxis Reinfeld - Raiffeisenpassage 15 - D-23858 Reinfeld - Germany

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 12, 2011

First Posted

May 2, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

PL(1)