Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics

Asthma Clinical Trial

Official title:

48-week,Multinational,Randomized,Double-blind,2-parallel Groups,Comparing the Efficacy of Foster for Maintenance and Reliever Versus Fixed-dose Foster for Maintenance Plus Salbutamol as Reliever in Asthmatics >=18 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861926
• Other study ID #: CCD-0804-PR-0034
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2009
• Last updated: March 28, 2017
• Start date: March 2009
• Est. completion date: April 2011

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

Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study

Description:

To compare efficacy of Foster as maintenance therapy plus additional inhalations as reliever with Foster as maintenance plus salbutamol as reliever in asthmatics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2079
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written signed and dated informed consent obtained.

• Male or female patients aged = 18 years.

• A positive reversibility test

• Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month)

• Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting beta2 agonists (LABA) at a constant dose for two months before screening visit

• Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007) in the last month before screening visit

• Forced expiratory volume in the first second (FEV1) = 60% of predicted for the patient normal value.

• Non smokers or ex-smokers

Exclusion Criteria:

• Pregnant or nursing (lactating) women. Women of child-bearing potential UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or are using one or more of acceptable methods of contraception

• Body Mass Index (BMI) > 34 kg/m2.

• Patient with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit.

• Use of systemic steroids in the last month.

• Patients with other lung diseases such as COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder.

• Patients who have an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease.

• Clinically relevant laboratory abnormalities

• Patients who have an abnormal QTcF interval value

• Intolerance or contra-indication to treatment with beta2-agonists and/or ICS or allergy to any component of the study treatments.

• Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.

• Patients being treated with anti-IgE antibodies.

• Patients treated with LABA or ICS/LABA fixed combination in the 24h before screening visit

• Severe asthma exacerbation in the last month before screening visit

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ventolin
Ventolin : salbutamol sulfate 100µg
• beclometasone /formoterol
BDP 100µg/FF 6µg, 1 inhalation bid

Locations

Country	Name	City	State
Italy	Pr Papi	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Papi A, Corradi M, Pigeon-Francisco C, Baronio R, Siergiejko Z, Petruzzelli S, Fabbri LM, Rabe KF. Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. Lancet Respir Med. 2013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first severe asthma exacerbation		At each clinic visit
Secondary	Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs		At each clinic visit

External Links

•   Study Record on EU Clinical Trials Register including results