CompletedNCT00862264Updated Mar 30, 2017

Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma

A Phase 3 interventional study of Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-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 2017-03-30.

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

Phase: Phase 3
Study type: Interventional
Enrollment: 286
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.

Read the detailed description

The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.

Conditions studied

Asthma

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Asthma 3,921

In context

Asthma

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

This study's enrollment of 286 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

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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.

Who can participate

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

Inclusion criteria

Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)
FEV1 > or = 60% and \< or = 85% of predicted normal values
Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three 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
Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities
Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability > or = 30% during 2 consecutive days, SABA use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 286 participants (actual)

Study arms

Experimental
CHF 1535 pMDI
CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose
Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Active comparator
BDP pMDI
Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose
Drug: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI

Interventions

DrugFixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI

What researchers measure

Primary outcomes

Pre-dose morning PEF
Time frame: At the end of treatment after 3 month of treatment

Secondary outcomes

Pre-dose FEV1 - Other spirometric parameters -
Time frame: Every 6 weeks
Percentage of night and/or days free of clinical symptoms
Time frame: End of treatment after 3 month of treatment
Morning and evening asthma clinical symptom scores
Time frame: End of treatment after 3 month of treatment
Use of rescue short-acting b2-agonists
Time frame: End of treatment after 3 month of treatment
Asthma exacerbations
Time frame: Every 6 weeks
Safety and Tolerability
Time frame: Every 6 weeks

Study locations

No study locations are listed for this record.

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00862264
Lead sponsor: Chiesi Farmaceutici S.p.A.
Responsible party: Sponsor
First posted: Mar 16, 2009
Start date: Aug 2004
Completion: Sep 2005
Last update: Mar 30, 2017

Study contacts

Françoise 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 Mar 2017. You cannot join it, but the record below documents what was studied.

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