NCT00476268

Brief Summary

Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
824

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_3 asthma

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, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

May 18, 2007

Last Update Submit

October 30, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Pre-dose morning PEF

    End of treatment

Secondary Outcomes (7)

  • Pre-dose FEV1

    At clinic visits

  • Other spirometric parameters

    At clinic visits

  • Morning and evening asthma clinical symptom scores

    End of treatment

  • Percentage of night and/or days free of clinical symptoms

    End of treatment

  • Use of rescue short-acting b2-agonists

    End of treatment

  • +2 more secondary outcomes

Study Arms (3)

beclometasone /formoterol

EXPERIMENTAL

beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI

Drug: beclomethasone/formoterol (100/6µg) pMDI

Beclomethasone

ACTIVE COMPARATOR

Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant.

Drug: Beclometasone dipropionate 250 µg/unit dose pMDI

Formoterol powder 12 µg/unit dose

ACTIVE COMPARATOR

Formoterol powder 12 µg/unit dose (Foradil™)

Drug: Formoterol powder 12 µg/unit dose

Interventions

beclomethasone/formoterol (100/6µg) pMDIDRUG

Two puffs b.i.d

beclometasone /formoterol
Beclometasone dipropionate 250 µg/unit dose pMDIDRUG

2 inhalations bid

Also known as: BecotideTM
Beclomethasone
Formoterol powder 12 µg/unit doseDRUG

2 inhalations bid

Also known as: Foradil™
Formoterol powder 12 µg/unit dose

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines)
  • FEV1 \> 40% and \< 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
  • Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:
  • µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)
  • A documented positive response to the reversibility test.

You may not qualify if:

  • Pregnant or lactating females or women of childbearing potential without any efficient contraception.
  • Heavy smokers defined as smoking for \> 10 pack years.
  • Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer.
  • Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.
  • Patients with an abnormal QTc interval value in the ECG test, defined as \> 450 msec in males or \> 470 msec in females.
  • Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability \> 30% during 2 consecutive days, SABA use \> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Huchon G, Magnussen H, Chuchalin A, Dymek L, Gonod FB, Bousquet J. Lung function and asthma control with beclomethasone and formoterol in a single inhaler. Respir Med. 2009 Jan;103(1):41-9. doi: 10.1016/j.rmed.2008.09.002. Epub 2008 Nov 1.

    PMID: 18977646RESULT

MeSH Terms

Conditions

Asthma

Interventions

BeclomethasoneFormoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, ChlorinatedEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Francoise Bonnet-Gonod

    Chiesi Farmaceutici

    STUDY DIRECTOR

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

May 18, 2007

First Posted

May 21, 2007

Study Start

February 1, 2004

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

October 31, 2024

Record last verified: 2024-10