E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Reversible airways obstruction in patients with Asthma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062109 |
E.1.2 | Term | Reversible airways obstruction |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006070 |
E.1.2 | Term | Br. asthma |
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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 |
The primary objective of this study (pilot trial) is to compare the efficacy of 6 mg Teikoku Tulobuterol Tape (TTT) with placebo in patients with persistent bronchial asthma. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to evaluate the inclusion/exclusion criteria and efficacy parameters for use in further tulobuterol development studies.
Another objective of this study is to gather safety data of TTT in the applied dosage of 6 mg per day. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Males or females, 18 to 70 years of age. 2.Documented diagnosis of bronchial asthma for at least 6 month prior to visit 1. 3.Pre-bronchodilator FEV1 between equal or higher than 50% and equal or lower than 90% of predicted. 4.Improvement in FEV1 of equal or higher than 15% of predicted over pre-bronchodilator FEV1 within 20-30 minutes following inhalation of 200 mcg of salbutamol (Ventolin) from MDI with spacer at Visit 1. 5.Constant asthma therapy with inhaled corticosteroids for at least 4 weeks prior to Visit 1 (see chapter permitted and not permitted asthma medication). 6.Female subjects must be using an acceptable birth control method, postmenopausal (defined as one year without menses), physically incapable of becoming pregnant or complete abstinence from intercourse from first visit until one week following study completion. Acceptable methods of birth control include hormonal contraceptives or IUD (intrauterine device) or double barrier methods (condom or diaphragm with spermicidal agent). If practicing an acceptable method of birth control, the subject must have a negative urine pregnancy test at Visit 3. 7.Subject has signed and dated an informed consent form. 8.Subject is willing and able to comply with all study procedures, visit schedules, use of home twice daily lung function measurement (PiKo-1) and diaries.
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E.4 | Principal exclusion criteria |
1.Upper or lower respiratory tract infection during the last 4 weeks prior to Visit 1. 2.Asthma exacerbation during the last 4 weeks prior to Visit 1. 3.Asthma exacerbation requiring treatment with oral or systemic corticosteroids during the last 12 weeks prior to Visit 1. 4.History of life-threatening asthma at any time prior to Visit 1 defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures. 5.Treatment with oral, systemic or depot corticosteroids during the last 12 weeks prior to Visit 1. 6.Any known adverse reaction including hypersensitivity to salbutamol (Ventolin) or study product or any of its constituents. 7.Patient is undergoing allergen desensitization therapy (SIT – specific immunotherapy). 8.Chronic obstructive pulmonary disease (COPD), allergic bronchopulmonary aspergillosis, cystic fibrosis. 9.Historical or current evidence of disease which, as judged by the investigator, may put the safety of the subject at risk through study participation or may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, hepatic disease, renal disease, malignancy, hematological disease, endocrine or pulmonary disease (including, but not confined, to chronic bronchitis, bronchiectasis with no need of treatment). 10.Neurological or psychiatric disease which will interfere with subject’s ability to comply with study protocol requirements. 11.History of (within the previous 3 years) or current drug or alcohol abuse. 12.Female subjects who are pregnant or lactating. 13.Current smoker or has a smoking history more than 10 pack years. 14.Subject requires hospitalization or elective surgery is scheduled during the period of the study. 15.Subject is working at night and/or employed in shift work. 16.Previous enrollment in this study, currently participating or previous participation in another study during the last 30 days prior to Visit 1 (V1). 17.Subject is Investigator’s or sub-Investigator’s family member or is the employee of the Investigator. 18.Any condition that at the Investigator opinion would interfere with evaluation of the subject or may put the subject at undue risk.
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change from baseline (V3) up to the end of treatment period week 8 (V7) of pre-bronchodilator FEV1 (% from baseline) in clinic visit. |
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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 | No |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |