Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)

Study Identifier:
CCD-0804-PR-0034
ClinicalTrials.gov Identifier:
NCT00861926
EudraCT Identifier:
2008-004671-22
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: Salbutamol
  • Drug: Beclomethasone dipropionate + Formoterol
Date
Mar 2009 - Dec 2010
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Written signed and dated informed consent obtained from patient;
  • Male or female patients aged ≥ 18 years;
  • Clinical diagnosis of asthma for ≥ 6 months;
  • A positive reversibility test, defined as an increase of at least 12% and at least 200 mL from pre-dose in FEV1 30 minutes following 4 puffs (4 × 100 μg) of inhaled salbutamol pMDI. If this could not be achieved, a documented reversibility test to salbutamol within the last 6 months was acceptable for eligibility;
  • Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month), defined as deterioration in asthma resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for at least 3 days because of asthma;
  • Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting β2 agonists (LABA) at a constant dose (changes in doses for less than seven days were accepted) for two months before V1.
  • If patients were under ICS only, the daily dose had to be ≥ non-extrafine 1000 μg BDP or equivalent.
  • If patients were under ICS + LABA, the ICS daily dose had to be ≥ non-extrafine 500 μg BDP or equivalent. LABA were to be stopped at least 24 hours before V1.
  • Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007) (apart from asthma exacerbation criteria) in the last month before V1.
  • Asthma control was assessed in terms of:
  • Daytime symptoms (more than twice a week);
  • Limitation of activities (any);
  • Nocturnal symptoms/awakening (any);
  • Need for rescue (more than twice a week);
  • Forced expiratory volume in the first second (FEV1) \< 80% predicted (or personal best, if known) on any day.
  • Partly controlled patients were those with at least one of the above mentioned symptoms/signs in any week of the last month before V1.
  • Uncontrolled patients were those with 3 or more features of partly controlled asthma present in any week of the last month before V1.
  • FEV1 ≥ 60% of predicted for the patient normal value;
  • Non smokers or ex-smokers (defined as those who have stopped smoking for more than one year and with a smoking history of less than 10 pack/years); Pack/year: number of cigarettes smoked per day multiplied by the number of years of smoking/20.
  • A co-operative attitude and ability to be trained to correctly use the pMDI;
  • Subjects who were willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Not fully controlled asthma (defined according to criterion No. 7) in the last week of the run-in was to be confirmed at Visit 2.
Exclusion Criteria
  • Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (\> 5 mIU/mL). Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precluded intercourse with a male partner and women whose partners had been sterilized by vasectomy or other means, unless they met 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 were using one or more of the following acceptable methods of contraception:
  • Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy);
  • Hormonal contraception (implantable, patch, oral);
  • Double-barrier methods (any double combination of: IUD, male or female condom, diaphragm, sponge, cervical cap).
  • Acceptable methods of contraception could include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensured compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal were not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation;
  • Body Mass Index (BMI) \> 34 kg/m2;
  • Patients 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 (but not limited to) COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder;
  • Patients who had an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that could, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study;
  • History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias;
  • Cancer or any other chronic disease with poor prognosis (less than 2 years) and /or affecting patient status;
  • Clinically relevant laboratory abnormalities such as (but not limited to) hypokaliemia (\<3.5 mEq/L), that could compromise patient's safety or compliance, interfere with evaluation, or preclude completion of the study, in the judgment of the investigator. Patients with uncontrolled diabetes, including patients with a history of serum glucose levels consistently out of the normal range (\> 140 mg/dl) or HbA1c \> 8.0%, were to be excluded from the study;
  • Patients who had an abnormal QTcF interval value in the screening visit ECG test (i.e., \> 450 msec in males or \> 470 msec in females);
  • Intolerance or contra-indication to treatment with β2-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 unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments;
  • Patients being treated with anti-IgE antibodies;
  • Patients treated with LABA or ICS/LABA fixed combination in the 24 hours before visit 1;
  • Patients having received an investigational drug within 2 months before the screening visit;
  • Inability to comply to study procedures or to study treatment intake;
  • Inability to carry out a valid spirometry;
  • Severe asthma exacerbation in the last month before screening visit;
  • Severe asthma exacerbation during the run-in period.
Healthy Volunteers
No

Protocol Summary

Primary objective:

The primary objective of the study was to compare the efficacy of Maintenance and Reliever Therapy (MART) with Foster® 100/6 μg (one inhalation bid) plus additional inhalations as needed, with the standard treatment of Foster® 100/6 μg (one inhalation bid) plus salbutamol 100 μg (Ventolin ®) additional inhalations as needed in not fully controlled asthmatic patients.

Secondary objectives:

The secondary objectives of the study were:

  • to evaluate the effect of treatments on lung function parameters and on other clinical outcome measures, and
  • to assess the safety and the tolerability of Foster® as MART.

Study Locations

Location
Status
Location
Chiesi Site No 103
Burgas, Bulgaria
Status
N/A
Location
Chiesi Site No 107
Pleven, Bulgaria
Status
N/A
Location
Chiesi Site No 105
Plovdiv, Bulgaria
Status
N/A
Location
Chiesi Site No 111
Plovdiv, Bulgaria
Status
N/A
Location
Chiesi Site No 115
Plovdiv, Bulgaria
Status
N/A
Location
Chiesi Site No 102
Rousse, Bulgaria
Status
N/A
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Study Publications

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.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.