E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 investigate the efficacy of an OTC cough product containing diphenhydramine (cs1002) versus Bell's simple linctus by comparing the change in severity of cough after 3 days of treatment(Day 4). |
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E.2.2 | Secondary objectives of the trial |
To compare the effectiveness of an over-the-counter cough product containing an antihistamine (diphenhydramine; cs1002) against Bell's simple linctus by comparing change from baseline using the Leicester Cough Questionnaire (LCQ-acute) total scores at Days 4, 6 and 8.
To determine the time for cough symptoms to disappear (defined as the day at which cough severity decreases to < 17mm on the scale used).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female subjects aged 18 years or over.
Subject has self-referred to the GP or Pharmacist owing to a new onset acute cough with a maximum of 7 days duration and a severity of at least 60 mm on a 0100 mm visual analogue scale (VAS).
Willing and able to give informed consent and of complying with the trial assessments and any other trial procedures.
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E.4 | Principal exclusion criteria |
Pregnant or lactating females.
Any relevant hospital stays of more than 2 days, within 6 months before the subject self refers to the GP or Pharmacist (Day 1). NB: An example of a relevant hospital stay would be for respiratory conditions such as ‘lung infection’ or ‘pneumonia’.
Current smokers and those who have smoked within the last two months. This includes the use of e-cigarettes.
Taken any medication with a cough treatment designation for this cough (whether a prescription drug, an OTC drug or a natural herbal product (e.g. honey, eucalyptus etc.).
A productive cough with excessive secretions, regardless of colour.
Subjects requiring co-prescription with other treatments for coughs or colds. This includes subjects taking antibiotics.
Subjects with known hypersensitivity to any of the ingredients of the study medication.
Subjects with chronic cough (i.e. chronic bronchitis in smokers, gastro-oesophageal reflux, asthma, hyper-responsive airways after resolution of respiratory tract infection, COPD, pertussis, aspiration, tumour, tuberculosis or fungal infections).
Subjects with prostatic hypertrophy, urinary retention, susceptibility to closed-angle glaucoma, liver disease fructose intolerance, glucose intolerance, glucose-galactose malabsorption, sucrose-isomaltase insufficiency.
Subjects taking monoamine oxidase inhibitors (MAOI) or having taken them within 14 days of entering the study and those requiring ongoing treatment with codeine, other anti-histamines, central nervous system depressants, other anticholinergic medicines (e.g. atropine), anti-psychotics or ACE inhibitors.
Treatment with any investigational drug agent during the 30 days before enrolment into the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in cough severity VAS scores after 3 Days of treatment (Day 4). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Cough severity VAS score at Day 4 will be evaluated at the end of the study. |
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E.5.2 | Secondary end point(s) |
Change from baseline in Leicester cough questionnaire total scores at Day 4, 6 and 8.
Change from baseline in cough severity at Day 5, and in cough frequency and sleep quality VAS scores at Day 4, 6 and 8.
Time to resolution of cough symptoms defined as the day at which cough severity decreases to <17mm. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Scores from Days 4,5,6 and 8 will be evaluated at the end of the study. |
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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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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
| 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 | 30 |
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 | 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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 2 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 2 |