E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The detection of bronchial hyperresponsiveness in patients with suspected asthma |
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MedDRA Classification |
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 estimate the sensitivity, specificity and positive and negative predictive values of a positive Aridol bronchial with respect to asthma diagnosis by a specialist pulmonary physician in corticosteroid-naive subjects presenting with signs and symptoms suggestive of asthma but without a definitive diagnosis. To demonstrate that Aridol has clinically acceptable sensitivity to detect asthma diagnosis by a specialist pulmonary physician in corticosteroid-naive subject presenting with signs and symptoms suggestive of asthma but without a definitive diagnosis. To demonstrate that the specificity of Aridol is superior to that of methacoline to detect asthma diagnosis by a specialist pulmonary physician in corticosteroid-naive subjects presenting with signs and symptoms suggestive of asthma but without a definitive diagnosis. |
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E.2.2 | Secondary objectives of the trial |
To compare correlations among the Aridol and methacholine when PD15 FEV1 and PD20 FEV1, resp. are compared. To determine the effect of atopy on the sensitivity and specificity of Aridol and methacholine challenges to detect asthma diagnosis by a specialist pulmonary physician in corticosteroid-naive subjects presenting with signs and symptoms suggestive of asthma but without a definitive diagnosis. To examine whether a positive Aridol bronchial identifies subjects with a different phenotype of asthma compared with metacholine positive subjects, assessed by self-reported respiratory symptoms and bronchodilator reversibility tests. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The subject must: have given informed consent to participate in this study, have been referred with a provisional diagnosis of asthma or have possible asthma, have an FEV1> 70% of the predicted value at visit 1, be between 16 and 50 years, be able to perform all of the techniques necessary to measure lung function, be able to understand the requirements of the study and be able to complete all of the forms necessary, be taking effective birth control if female of childbearing potential |
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E.4 | Principal exclusion criteria |
The subject must NOT: use medications six weeks prior to the Screening visit or during the study that would interfere with bronchial provocation challenge testing, currently use cholinesterase-inhibitor medication , have had upper or lower respiratory tract infection within the previous 6 weeks, have known aortic or cerebral aneurysm, cirrhosis or portal hypertension, have had recent major surgery, have had recent cataract surgery, have a history of heart disease that would increase risk risk of performing methacholine or Aridol challenge, have had cardiac ischemia or malignant arrhytmias, have uncontrolled hypertension, have smoked within the past year or have a >10 pack year smoking history, have other chronic restrictive or obstructive pulmonary diseases, have a clinically significantly abnormal chest X-ray, be skin test positive to seasonal and perennial aeroallergens that are present in the environment during the time that the subject is participating in the study, have a medical condition that in the opinion of the Investigator would impair the ability of the subject to participate, have an inability to perform spirometry of acceptable quality, be intolerant to Aridol, methacholine or salbutamol, be pregnant or lactating, have participated in any other investigative drug study within 4 weeks of study entry, have previously received an Aridol challenge
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E.5 End points |
E.5.1 | Primary end point(s) |
Sensitivity and specificity of Aridol (with Aridol positivity defined as PD 15 FEV1 at any dose until the maximum dose has been given) and methacholine (with methacholine positivity defined as PD20 FEV1 less than or equal to 800 microg) with respect to a specialist pulmonologist diagnosis of asthma in subjects presenting with symtoms suggestive of asthma but without a definitive diagnosis |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
methacholine (ex tempore) |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |