Effect of Cyclodextrin on Sensory Nerve Activity: A Novel Anti-tussive Therapy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01960621
First received: May 8, 2008
Last updated: February 26, 2014
Last verified: September 2012
  Purpose

The investigators want to see whether the test drug in this research study, 2-hydroxypropyl-beta-cyclodextrin (2HPBCD), might potentially be able to improve cough in healthy volunteers. The investigators are initially recruiting healthy volunteers such as who are free from any respiratory disease and not on any concurrent medication, so there are no confusing effects from pre-existing respiratory symptoms or disease, nor interaction of any medication with the test drug.


Condition Intervention Phase
Cough
Drug: cyclodextrin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Cyclodextrin on Sensory Nerve Activity and the Cough Relex in Man: A Novel Anti−Tussive Therapy

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Capsaicin Cough Challenge [ Time Frame: 0-30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: December 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Drug: cyclodextrin
intravenous

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy non−smoking participants (we have excluded smoking participants in light of the greater potential for cough to be present as a result of their smoking habit and they may be unduly sensitive to inhaled cough stimuli, such as the inhaled capsaicin cough challenge)
  • Age 18−65 years
  • No history of respiratory disease
  • Normal baseline spirometry as predicted for age, sex and height (we have excluded those with abnormal spirometry, as we aim to induce cough in our otherwise healthy volunteer participants. Also, abnormal spirometry in the presence of no respiratory symptoms − may indicate an underlying lung condition that needs attention, and such participants will be told their result and with their consent, the information will be forwarded to their General Practitioner, as part of the safety and well−being of the research participant).
  • No history of allergic disease i.e., a negative skin prick test(we have excluded those with allergic disease as they may have a heightened sensitivity to inhaled cough stimuli, such as the inhaled capsaicin cough challenge)
  • Participants who are free from significant cardiac, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease
  • Not taking any regular medication, other than the oral contraceptive pill (we do not want any interaction with other medication that the participant may be taking i.e. we hope to measure the cough 'tussive' response in our healthy volunteers solely as a result of the effect of our compound under investigation, 2HPBCD)
  • All participants must have a minimum gap of one−month from completion of a previous study, before commencement in this current study

Exclusion Criteria:

  • History of respiratory disease (we have excluded those with respiratory disease so that the outcome, attenuation of the induced capsaicin cough response by intravenous 2HPBCD, is unaffected by any respiratory disease status of the participant)
  • History of upper respiratory tract infection or respiratory symptoms in the preceding six weeks (as respiratory tract infections may cause cough or highly sensitize the respiratory airways to inhaled cough stimuli, such as the inhaled capsaicin cough challenge i.e. the induced cough capsaicin challenge will not be a true reflection of cough in the healthy volunteer participant)
  • Evidence of a positive pregnancy test (urine beta−human chorionic gonadotrophin level) for female volunteers or female participants that are pregnant or lactating or are likely to become pregnant during the trial. Women of childbearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions
  • Gastrointestinal symptoms such as a recent alteration in bowel habit or new bowel symtpoms including participants with a known or suspected history of lactose intolerance (as 2HPBCD when given as an oral tablet in chronic dosing, has been shown to sometimes cause flatulence, diarrhea, soft stools and abdominal cramps)
  • Participants susceptible to renal impairment from their medical history (symptoms of renal failure, medical conditions predisposing to renal impairment such as diabetes, history of recurrent urinary infection either as an adult or in childhood, history of peripheral vascular disease/stroke/coronary heart disease/hypercholestrolaemia/hyperlipidaemia), or from their medical examination (kidney size, renal bruits, peripheral upper and lower limb arterial pulses)or from their urine analysis on urine 'dipstick' (glucose, protein, blood). Any positive finding listed above will lead to exclusion of the participant from the clinical study
  • Participants with an abnormal urine cytology. Any positive finding in this tests will lead to exclusion of the participant from the clinical study
  • Participants who are unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960621

Contacts
Contact: O S Usmani, MD, PhD 44-207-351-8051 o.usmani@imperial.ac.uk

Locations
United Kingdom
Asthma Lab, Royal Brompton Hospital Not yet recruiting
London, United Kingdom, SW3 6LY
Contact: O S Usmani, MD, PhD    44-207-351-8051    o.usmani@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: O S Usmani, MD, PhD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01960621     History of Changes
Other Study ID Numbers: 06/Q0406/102
Study First Received: May 8, 2008
Last Updated: February 26, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014