search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ventolin
beclometasone /formoterol
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Maintenance and Reliever Treatments

Eligibility Criteria

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

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

Sites / Locations

  • Pr Papi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Beclometasone/formoterol (100/6 µg)

salbutamol

Arm Description

Foster : fixed combination of BDP extrafine 100 µg plus formoterol fumarate 6 µg administered via a pMDI standard actuator

Ventolin : salbutamol sulphate 100 µg per metered dose

Outcomes

Primary Outcome Measures

Time to first severe asthma exacerbation

Secondary Outcome Measures

Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs

Full Information

First Posted
March 13, 2009
Last Updated
March 28, 2017
Sponsor
Chiesi Farmaceutici S.p.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT00861926
Brief Title
Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Double-blind, multinational, multicentre, randomized, 2-arm parallel-group study
Detailed Description
To compare efficacy of Foster as maintenance therapy plus additional inhalations as reliever with Foster as maintenance plus salbutamol as reliever in asthmatics

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Maintenance and Reliever Treatments

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2079 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beclometasone/formoterol (100/6 µg)
Arm Type
Experimental
Arm Description
Foster : fixed combination of BDP extrafine 100 µg plus formoterol fumarate 6 µg administered via a pMDI standard actuator
Arm Title
salbutamol
Arm Type
Active Comparator
Arm Description
Ventolin : salbutamol sulphate 100 µg per metered dose
Intervention Type
Drug
Intervention Name(s)
Ventolin
Intervention Description
Ventolin : salbutamol sulfate 100µg
Intervention Type
Drug
Intervention Name(s)
beclometasone /formoterol
Other Intervention Name(s)
Foster
Intervention Description
BDP 100µg/FF 6µg, 1 inhalation bid
Primary Outcome Measure Information:
Title
Time to first severe asthma exacerbation
Time Frame
At each clinic visit
Secondary Outcome Measure Information:
Title
Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs
Time Frame
At each clinic visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Papi, Professor
Organizational Affiliation
Universita degli Studi di Ferrara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pr Papi
City
Ferrara
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24321801
Citation
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 Mar;1(1):23-31. doi: 10.1016/S2213-2600(13)70012-2. Epub 2013 Mar 4.
Results Reference
result
PubMed Identifier
31695864
Citation
Morjaria JB, Rigby AS, Morice AH. Symptoms and exacerbations in asthma: an apparent paradox? Ther Adv Chronic Dis. 2019 Oct 24;10:2040622319884387. doi: 10.1177/2040622319884387. eCollection 2019.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2008-004671-22
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

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

We'll reach out to this number within 24 hrs