E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute persistent cough with no established diagnosis |
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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 assess the efficacy of montelukast in the treatment of acute persistent cough in young people and adults. |
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E.2.2 | Secondary objectives of the trial |
1)To assess the feasibility of performing a double blind randomised placebo controlled trial of montelukast in the treatment of acute persistent cough in young people and adults with whooping cough. 2)To assess the validity of subjective cough outcome measures (diary-recorded paroxysms of cough, cough visual analogue scale score and exercise-related cough score) in relation to objective cough frequency measured using the Leicester Cough Monitor. 3)To compare subsequent intervention rates (re-consultation, investigation, prescription of other medication) in young people and adults with acute persistent cough treated with montelukast versus placebo. 4)To assess the adverse event profile of montelukast in the treatment of acute persistent cough in young people and adults. 5)To examine the relationship between exercise and cough in young people and adults with acute persistent cough. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)Male or Female, aged 16 years to 49 years inclusive. 2)Presenting with a persistent cough of 2-8 weeks' duration without an established diagnosis (e.g. asthma, gastro-oesophageal reflux). 3)Able to complete cough diary and study questionnaires.
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E.4 | Principal exclusion criteria |
The participant may not enter the study if ANY of the following apply: 1)There is a contraindication to montelukast 2)Chronic severe disease which may cause persistent cough (eg cystic fibrosis, bronchiectasis, cardiac failure) 3)Immunodeficiency/immunocompromised state 4)Pregnancy 5)Breastfeeding 6)Current smoker (i.e. stopped smoking less than 6 months ago). 7)Regular medication associated with persistent cough (ACE inhibitors) 8)The individual is in another clinical research study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
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 | Yes |
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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The end of the trial will occur when the last recruited participant has had his or her final assessment and his or her cough diary has been received by the coordinating centre. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |