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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476268
• Other study ID #: DM/PR/033011/003/03
• Status: Completed
• Phase: Phase 3
• Start date: February 2004
• Est. completion date: January 2005

Study information

• Verified date: July 2020
• 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 beclometasone/formoterol in patients with moderate to severe persistent asthma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 824
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• beclomethasone/formoterol (100/6µg) pMDI
Two puffs b.i.d
• Beclometasone dipropionate 250 µg/unit dose pMDI
2 inhalations bid
• Formoterol powder 12 µg/unit dose
2 inhalations bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-dose morning PEF		End of treatment
Secondary	Pre-dose FEV1		At clinic visits
Secondary	Other spirometric parameters		At clinic visits
Secondary	Morning and evening asthma clinical symptom scores		End of treatment
Secondary	Percentage of night and/or days free of clinical symptoms		End of treatment
Secondary	Use of rescue short-acting b2-agonists		End of treatment
Secondary	Asthma exacerbations		end of treatment
Secondary	safety and tolerability		end of treatment