| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10003553 |
| E.1.2 | Term | Asthma |
| E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To investigate that 200mg of drug CDR007 taken by mouth twice a day for controlling asthma will perform as expected while their normal standard asthma treatment is being reduced. |
|
| E.2.2 | Secondary objectives of the trial |
If the new drug CDR007 fails to treat subjects asthma during the reduction of their normal standard treatment because:
The subject is unable to reduce one of their normal treatments as recorded in a questionnaire.
Subject is withdrawn due to having a questionnaire score which is too high on the maximum dose of one treatment.
Subject has severe worsening of asthma.
Worsening of asthma 2 days running identified by 1) 30% or more of their blowing test in the morning compared to their old treatment. 2) Having 6 or more puffs on their salbutamol inhaler( normal puffer treatment to relieve symptoms) during a 24 hour period compared to their old treatment.
Withdrawn from trial due to worsening of asthma
Any untoward medical occurrence unfavourable and unintended
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Written informed consent must be obtained before any trial related procedures are
performed
2. Age ≥18 years old
3. Diagnosis of asthma according to GINA Guidelines (1)
4. Atopic phenotype as assessed by Investigator based on:
o Positive skin prick test or
o Positive specific IgE test or
o Medical history
5. Treated with ICS and LABA for at least 12 weeks prior to Visit 1 with a daily ICS dose equivalent to ≥400μg and ≤800μg budesonide and a daily stable LABA dose.
6. Blood eosinophils ≥0.05*109/L at Visit 1
7. Demonstration of FEV1 ≥60% of the predicted value at Visit 1
8. Demonstration of ACQ6 ≥ 0.5 and ≤2.5 at Visit 1
9. Reversibility of at least 12% and 200 mL in FEV1 after 200 µg to 800 µg of Salbutamol Dry Powder Inhaler (DPI) or 400 mg Salbutamol via pressurised metered dose inhaler (pMDI) with or without spacer at Visit 1 or Visit 2. Note: SABA should be withheld 8 hours and ICS/LABA 24 hours before the reversibility test
10. Ability to use Turbuhaler® correctly
|
|
| E.4 | Principal exclusion criteria |
1. Lower respiratory tract infection <6 weeks prior to Visit 1
2. Current smokers
3. Ex-smokers with a smoking history of >10 pack years (e.g. 10 pack years = 1 pack/day x
10 years, or ½ pack/day x 20 years). An ex-smoker may be defined as a subject who has
not smoked for >6 months prior to Visit 1
4. Treatment with any of the medications listed below <6 weeks prior to Visit 1:
o Systemic (oral or parental) corticosteroids
o Any systemic immunomodulatory therapy introduced <6 months prior to Visit 1
o Any treatment with biologics
5. BMI which is judged by the investigator to interfere with trial procedures and results
6. Known HIV positive
7. Known active hepatitis B or C
8. Significant concurrent, uncontrolled medical condition including, but not limited to,
renal, hepatic, cardiac, haematological, gastrointestinal, endocrine, inflammatory, autoimmune, pulmonary, neurological, cerebral or psychiatric disease evaluated by the Investigator to interfere with effect of the trial drug
9. Subjects who have a clinically significant abnormal laboratory value except blood eosinophils at Screening (Visit 1) and would be at potential risk if enrolled in the trial as
evaluated by the Investigator
10. Known uncontrolled allergic conditions or allergy/hypersensitivity to any component of the trial drug or placebo excipients
11. Pregnant and breast-feeding female subjects
12. Female subjects of childbearing potential not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local requirements or practice)
during participation in the trial until at least 3 days after last intake of IMP
13. Male subjects not surgically sterilised, who or whose partner is not using adequate
contraceptive methods (adequate contraceptive measures as required by local
requirements or practice) during participation in the trial until at least 3 days after last
intake of IMP
14. Receipt of any experimental agents within 30 days prior to Visit 1
15. Participation in any other interventional clinical trial during the trial period
16. Parasitic infection within 6 months prior to Screening
17. Travels to parasitic endemic areas within 6 months prior to Screening
18. Subjects known or suspected of not being able to comply with the trial-related procedures
(due to e.g. alcoholism, psychiatric disorder, language problems) |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary variable, average daily budesonide dose, will be compared between treatments using an analysis of variance model with fixed factors treatment and country and pre-trial daily steroid dose as covariate. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| The primary endpoint of identifying the average dose of ICS, from fortnightly visits from visit 5 to Visit 10 (10 weeks in total). |
|
| E.5.2 | Secondary end point(s) |
Secondary Objective is to investigate the safety profile of 200 mg CRD007 administered orally b.i.d. by the following:
assessing treatment failure from randomisation (Visit 3)
Subject is withdrawn due to asthma exacerbation ( use of corticoidsteroids fro at least 3 days, inpatient hospitalisation, emergency room visit)
Worsening of asthma during 2 consecutive days day or night
6 additional reliever puffs of Short Acting Beta Agonist (SABA) during a 24 hour period
Subject does not fulfil criteria for reduced ICS dose.
Subject is withdrawn from the trial due to ACQ6 >1.5 at Visit 5
Safety profile of CRD007 |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| These will be assessed from visit 3 to visit 11 a total of 16 weeks. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 1 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
| E.8.9.2 | In all countries concerned by the trial days | 1 |
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