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CompletedNCT00476268Updated Oct 31, 2024

Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma

A Phase 3 interventional study of beclomethasone/formoterol (100/6µg) pMDI and Beclometasone dipropionate 250 µg/unit dose pMDI in Asthma, sponsored by Chiesi Farmaceutici S.p.A.. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Chiesi Farmaceutici S.p.A. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
824
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

The purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. Patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: BDP/FF 400/24 mcg) or beclometasone CFC + formoterol DPI (total daily dose: BDP 1000 mcg + FF 24 mcg) or beclometasone CFC (total daily dose: BDP 1000 mcg) during 24 weeks of treatment.

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Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 824 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Chiesi Farmaceutici S.p.A. is the lead sponsor of 182 studies on the registry; 22 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 11 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)

  • Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms > 3 times in the week prior to inclusion
  • A documented positive response to the reversibility test.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating females or women of childbearing potential without any efficient contraception.
  • Heavy smokers defined as smoking for > 10 pack years.
  • Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids).
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
824 participants (actual)

Study arms

  • Experimental
    beclometasone /formoterol

    beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI

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

  • Active comparator
    Beclomethasone

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

    Drug: Beclometasone dipropionate 250 µg/unit dose pMDI

  • Active comparator
    Formoterol powder 12 µg/unit dose

    Formoterol powder 12 µg/unit dose (Foradil™)

    Drug: Formoterol powder 12 µg/unit dose

Interventions

  • Drugbeclomethasone/formoterol (100/6µg) pMDI

    Two puffs b.i.d

  • DrugBeclometasone dipropionate 250 µg/unit dose pMDI

    2 inhalations bid

    Also known as: BecotideTM

  • DrugFormoterol powder 12 µg/unit dose

    2 inhalations bid

    Also known as: Foradil™

06

What researchers measure

Primary outcomes

  1. Pre-dose morning PEF

    Time frame: End of treatment

Secondary outcomes

  1. Pre-dose FEV1

    Time frame: At clinic visits

  2. Other spirometric parameters

    Time frame: At clinic visits

  3. Morning and evening asthma clinical symptom scores

    Time frame: End of treatment

  4. Percentage of night and/or days free of clinical symptoms

    Time frame: End of treatment

  5. Use of rescue short-acting b2-agonists

    Time frame: End of treatment

  6. Asthma exacerbations

    Time frame: end of treatment

  7. safety and tolerability

    Time frame: end of treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18977646 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00476268
Lead sponsor
Chiesi Farmaceutici S.p.A.
Responsible party
Sponsor
First posted
May 21, 2007
Start date
Feb 2004
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Oct 31, 2024

Study contacts

Francoise Bonnet-Gonod
study director · Chiesi Farmaceutici

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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