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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00861926
First received: March 13, 2009
Last updated: February 14, 2012
Last verified: February 2012

March 13, 2009
February 14, 2012
March 2009
December 2010   (final data collection date for primary outcome measure)
Time to first severe asthma exacerbation [ Time Frame: At each clinic visit ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00861926 on ClinicalTrials.gov Archive Site
Number of severe asthma exacerbations Number of hospitalization Asthma symptoms Rescue medication LFTs [ Time Frame: At each clinic visit ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Comparing Foster Efficacy Maintenance and Reliever Versus Foster Maintenance + Salbutamol Reliever in Asthmatics
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

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: Ventolin
    Ventolin : salbutamol sulfate 100µg
    Other Name: Ventolin
  • Drug: beclometasone /formoterol
    BDP 100µg/FF 6µg, 1 inhalation bid
    Other Name: Foster
  • Experimental: Beclometasone/formoterol (100/6 µg)
    Foster : fixed combination of BDP extrafine 100 µg plus formoterol fumarate 6 µg administered via a pMDI standard actuator
    Intervention: Drug: beclometasone /formoterol
  • Active Comparator: salbutamol
    Ventolin : salbutamol sulphate 100 µg per metered dose
    Intervention: Drug: Ventolin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2079
April 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00861926
CCD-0804-PR-0034
No
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Principal Investigator: Alberto Papi, Professor Universita degli Studi di Ferrara
Chiesi Farmaceutici S.p.A.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP