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

Asthma Clinical Trial

Official title:

A 12-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Mild to Moderate Persistent Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862264
• Other study ID #: RA/PR/033011/005/04
• Secondary ID: 2004-000718-37
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2009
• Last updated: March 28, 2017
• Start date: August 2004
• Est. completion date: September 2005

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-dose morning PEF		At the end of treatment after 3 month of treatment
Secondary	Pre-dose FEV1 - Other spirometric parameters -		Every 6 weeks
Secondary	Percentage of night and/or days free of clinical symptoms		End of treatment after 3 month of treatment
Secondary	Morning and evening asthma clinical symptom scores		End of treatment after 3 month of treatment
Secondary	Use of rescue short-acting b2-agonists		End of treatment after 3 month of treatment
Secondary	Asthma exacerbations		Every 6 weeks
Secondary	Safety and Tolerability		Every 6 weeks

External Links

•   Study Record on EU Clinical Trials Register including results