NCT00862394

Brief Summary

To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids

Trial Health

87
On Track

Trial Health Score

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

Enrollment
783

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

March 13, 2009

Last Update Submit

April 12, 2018

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic

    3 month period

Secondary Outcomes (8)

  • Pre-dose FEV1

    every month

  • Post-dose FEV1 AUC 0-8 h

    3 month period

  • FVC and FEF 25-75%

    every month

  • PEF

    every day

  • Morning and evening asthma clinical symptoms scores

    every day

  • +3 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg

Drug: BDP/Formoterol Next DPI

2

ACTIVE COMPARATOR

CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg

Drug: Foster

3

EXPERIMENTAL

CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg

Drug: BDP/Formoterol Next DPI

4

ACTIVE COMPARATOR

CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg

Drug: Foster

Interventions

BDP/Formoterol Next DPIDRUG

BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)

1
FosterDRUG

BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)

2

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Outpatients of both sexes, aged \> 12 years
  • Moderate to severe symptomatic asthma
  • Forced expiratory volume in the first second (FEV1) \> 40% and \< 80% of the predicted normal values
  • Reversibility test
  • "Partly controlled" asthma (GINA revised 2006)
  • Patients free of long-acting beta2-agonists (LABAs) treatment
  • Under inhaled corticosteroids (ICS) treatment
  • A minimum inspiratory flow ≥ 40 L/min 10.
  • Non-smokers or ex smokers
  • Asthma Control Questionnaire ACQ score ≥ 1.5

You may not qualify if:

  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception
  • Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
  • History of near fatal asthma
  • Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
  • Diagnosis COPD
  • 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 (3 months for parenteral depot corticosteroids)
  • Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
  • Allergy to any component of the study treatments
  • Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
  • Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
  • Patients with abnormal QTc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oliver Kornmann - National Coordinator in Germany

Mainz, 55131, Germany

Location

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 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

March 13, 2009

First Posted

March 16, 2009

Study Start

February 1, 2009

Primary Completion

October 1, 2009

Study Completion

January 1, 2010

Last Updated

April 13, 2018

Record last verified: 2018-04

Locations

DE(1)