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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01960621
Recruitment Status : Terminated (Study has not been able to start due to difficulty in obtaining an intravenous formulation of cyclodextrin (intravenous 2HPBCD) suitable for man)
First Posted : October 10, 2013
Last Update Posted : August 27, 2015
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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 or disease Intervention/treatment Phase
Cough Drug: cyclodextrin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 2 Drug: cyclodextrin

Primary Outcome Measures :
  1. Capsaicin Cough Challenge [ Time Frame: 0-30 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01960621

United Kingdom
Asthma Lab, Royal Brompton Hospital
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Imperial College London
Principal Investigator: O S Usmani, MD, PhD Imperial College London

Responsible Party: Imperial College London Identifier: NCT01960621     History of Changes
Other Study ID Numbers: 06/Q0406/102
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Antitussive Agents
Chlorpheniramine, phenylpropanolamine drug combination
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents