An open label study to assess the utility of measuring markers of inflammation, to detect transition from optimal to sub-optimal Inhaled corticosteroid therapy in moderatesevere bronchial asthma
- Conditions
- Moderate severe bronchial asthma
- Registration Number
- EUCTR2006-002289-21-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 26
1. Male and/or female moderate to severe asthmatic patients, from 18-75 years of age.
2. Diagnosis of Moderate to severe asthma, according to the GINA guidelines, for at least one year with no exacerbations requiring hospitalization and/or oral steroids within the previous three months. No concomitant lung disease or significant medical conditions that would affect the subjects’ safety from participating in the study, or that would be expected to impact on the result from the study.
3. Fluticasone propionate 500mcg daily or greater, or equivalent (Mometasone 800 mcg, triamcinolone 2000 mcg, Flunisolide 2000 mcg, Budesonide DPI 800 mcg,
Beclomathasone HFA 500 mcg, Beclomethasone CFC 1000 mcg)
4. FEV1 at screening will be = 70% of the normal predicted FEV1.
5. Evidence of asthma, demonstrated by one of the following:
Historical evidence confirmed by their treating physician.
or
Demonstration of = 12% reversibility of FEV1 using a standard dose of salbutamol (up to 400 µg) within 30 minutes. This criterion for FEV1 will have to be demonstrated
after a washout period of at least 6 h during which no short-acting ß2-agonist has been inhaled, or longer as required for long-acting ß2-agonist.
or
Documented bronchial hyper-reactivity to (=8 mg/mL) metacholine or histamine
challenge.
6. Female subjects of child bearing potential must be using two forms of contraception,
either double-barrier local contraception, i.e. intra-uterine device plus condom, or
spermicidal gel plus condom, or the contraceptive pill plus condom.
or:
Postmenopausal women must have no regular menstrual bleeding for at least 2 years prior
to inclusion. Menopause will be confirmed by laboratory tests.
7. Body Mass Index between 18 and 30. Body weight should be less than 100 kg.
8. Able to provide written informed consent prior to study participation.
9. Able to communicate well with the investigator and comply with the requirements of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Smokers with a history of tobacco use greater than 10 pack years (use of tobacco products in the previous 3 months). Smokers will be defined as any subject who reports cigarette use.
2. Concomitant medications:
• Except for short acting ß2-agonists for symptom relief and long acting ß-agonists (in
case this was part of patients usually prescribed medication) medication associated
with study procedures and medication which may be required to treat adverse events, all other medications, other than study drug should be avoided from screening until all of the study completion evaluations have been conducted. Paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF. A washout period of 3 months is required for previous administration of any biologic therapy. The following wash-out periods should be adhered to for asthma treatments:
• Increase in Inhaled steroid use: 6 weeks before study start and during study.
• Oral steroids: 8 weeks before study and during study.
• Topical steroids: 4 weeks before study and during study (of if not possible, dose
should remain constant for the two weeks before and during the study).
• Antileukotrienes: 4 weeks before study start and during study.
• Antihistamines/cromoglycates: 4 weeks and during study.
• Theophyllin: 4 weeks before and during study.
3. Medical conditions:
• history of clinically significant drug allergy;
• any significant medical condition that in the opinion of the Investigator may
compromise subject safety, subject compliance, interfere with evaluations, or
preclude completion of the trial. For example, a history of any pulmonary disorder
other than asthma.
4. Any surgical or medical condition which might significantly alter the distribution,
metabolism or excretion of the drug.
5. Participation in any clinical investigation within 4 weeks prior to dosing or longer if
required by local regulation.
6. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or longer if required by local regulation.
7. Significant illness within the two weeks prior to dosing.
8. A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
9. History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus
arrhythmia).
10. A known hypersensitivity to Fluticasone propionate or drugs similar to Fluticasone
propionate.
11. History of immunocompromise, including a positive HIV test result.
12. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
13. History of drug or alcohol abuse within the 12 months prior to dosing
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method