Pharmacological modulation of the urge to cough: the effects of morphine sulphate

Not Applicable

Completed

• Conditions: Chronic cough; Signs and Symptoms; Cough

• Registration Number: ISRCTN13279602
• Lead Sponsor: niversity Hospital of South Manchester NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-06
• Study Completion: 2016-03-01
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Phase 1 (healthy volunteers):
1. Healthy male or female aged over 18 years
2. Nonsmoker
3. Normal spirometry
4. No history of asthma

Phase 2 (chronic cough patients):
1. Male or female age over 18 years
2. Diagnosed with idiopathic chronic cough (greater than 8 weeks duration)
3. Normal spirometry
4. Treated with low dose (5 to 10 mg) Morphine Sulphate twice daily and willing to temporarily withdraw morphine treatment for study purposes

Exclusion Criteria

Phase 1 (healthy volunteers):
1. Male or female <18 years old
2. Current smoker
3. History of asthma or other chronic respiratory disease

Phase 2 (chronic cough patients):
1. Current use of medications potentially modifying cough reflex sensitivity e.g. Amitriptyline, Pregabalin, Codeine, etc
2. History of medical conditions potentially modifying cough reflex sensitivity e.g. Diabetes Mellitus with autonomic neuropathy, neurological conditions e.g. cerebrovascular disease, Parkinson’s disease etc
3. Recent upper respiratory tract infection (<4 weeks)
4. Pregnancy/breastfeeding. Women of childbearing potential (not >2 years postmenopausal and/or not surgically sterilised) must have a negative urine pregnancy test, performed at visit 1 prior to administration of study medication
5. Current smokers or exsmokers with <6 months abstinence or cumulative history of >10 pack years
6. Current treatment with ACE inhibitors
7. Drug or alcohol abuse
8. Uncontrolled hypertension (i.e., >160/90 mmHg despite adequate medical therapy)
9. Recent myocardial infarction, or history of congestive cardiac failure
10. Any clinically significant neurological disorder
11. Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient’s ability to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1 (healthy volunteers):<br>To evaluate the differences in citric acid threshold at which initial throat sensations and the urge to cough are reported<br><br>Phase 2 (chronic cough patients):<br>To evaluate the within-subject differences in urge-to-cough (UTC) ratings with citric acid inhalation with morphine compared with placebo therapy