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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Severe Asthma Exacerbation
Timeframe: From First IMP dose to week 48 (EOT)
2
Cumulative Number of Patients With Severe Asthma Exacerbation by Inter-visit (Measured in Weeks)
Timeframe: From First dose to end of each interval: 0-4, 4-12, 12-24, 24-36, 36-48 weeks
. 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.
. FEV1 ≥ 60% of predicted for the patient normal value;
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:
. Double-barrier methods (any double combination of: IUD, male or female condom, diaphragm, sponge, cervical cap).
. 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;