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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

beclomethasone/formoterol (100/6µg) pMDI

Beclometasone dipropionate 250 µg/unit dose pMDI

Formoterol powder 12 µg/unit dose

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

beclometasone /formoterol

Beclomethasone

Formoterol powder 12 µg/unit dose

Arm Description

beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI

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

Formoterol powder 12 µg/unit dose (Foradil™)

Outcomes

Primary Outcome Measures

Pre-dose morning PEF

Secondary Outcome Measures

Pre-dose FEV1

Other spirometric parameters

Morning and evening asthma clinical symptom scores

Percentage of night and/or days free of clinical symptoms

Use of rescue short-acting b2-agonists

Asthma exacerbations

safety and tolerability

Full Information

NCT ID

NCT00476268

First Posted

May 18, 2007

Last Updated

July 30, 2020

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT00476268

Brief Title

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

Official Title

A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

January 2005 (Actual)

Study Completion Date

January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

824 (Actual)

8. Arms, Groups, and Interventions

Arm Title

beclometasone /formoterol

Arm Type

Experimental

Arm Description

beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI

Arm Title

Beclomethasone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Formoterol powder 12 µg/unit dose

Arm Type

Active Comparator

Arm Description

Formoterol powder 12 µg/unit dose (Foradil™)

Intervention Type

Drug

Intervention Name(s)

beclomethasone/formoterol (100/6µg) pMDI

Intervention Description

Two puffs b.i.d

Intervention Type

Drug

Intervention Name(s)

Beclometasone dipropionate 250 µg/unit dose pMDI

Other Intervention Name(s)

BecotideTM

Intervention Description

2 inhalations bid

Intervention Type

Drug

Intervention Name(s)

Formoterol powder 12 µg/unit dose

Other Intervention Name(s)

Foradil™

Intervention Description

2 inhalations bid

Primary Outcome Measure Information:

Title

Pre-dose morning PEF

Time Frame

End of treatment

Secondary Outcome Measure Information:

Title

Pre-dose FEV1

Time Frame

At clinic visits

Title

Other spirometric parameters

Time Frame

At clinic visits

Title

Morning and evening asthma clinical symptom scores

Time Frame

End of treatment

Title

Percentage of night and/or days free of clinical symptoms

Time Frame

End of treatment

Title

Use of rescue short-acting b2-agonists

Time Frame

End of treatment

Title

Asthma exacerbations

Time Frame

end of treatment

Title

safety and tolerability

Time Frame

end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francoise Bonnet-Gonod

Organizational Affiliation

Chiesi Farmaceutici

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

18977646

Citation

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.

Results Reference

result

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

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