CoughPhase 2NCT03415269
A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough.
A Phase 2 study testing Ambroxol Hydrochloride in people with Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
To assess the effect of a single doses of 20 mg ambroxol hydrochloride on cough reflex sensitivity to citric acid, capsaicin, adenosine triphosphate (ATP) and distilled water in patients with acute cough related to upper respiratory tract infection Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- Ambroxol Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2018to 19 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be informed of the nature of the study and have provided written informed voluntary consent;
- Be able to speak, read, and understand English;
- Be males or females, of any race, between 18 and 80 years of age, inclusive;
- Subject has an acute cough and other symptoms consistent with a common cold or an acute upper respiratory tract infection (URTI) diagnosis deemed by the investigator based on findings from medical history review, full physical examination and vital signs;
- The onset of symptoms must be within 72 h of study enrolment;
- Have a Cough Severity VAS ≥ 40 mm at Screening;
Show all 11Show fewer
- Be in good general health (other than URTI) with no clinically relevant abnormalities based on the medical history, physical examination, and 12 lead electrocardiogram;
- Cough at least twice to all cough challenge Agents - citric acid, capsaicin, ATP and distilled water cough challenges at baseline.
- If a female of child-bearing potential (i.e., have not undergone a hysterectomy or bilateral oophorectomy) or not post-menopausal (defined as no menses for at least 12 months), agree to use 2 forms of acceptable birth control from Screening through to the Follow Up Visit; or if a male, they and/or their partner of child-bearing potential agree to use 2 forms of acceptable birth control from Screening through the Follow Up Visit;
- Be able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions.
- -
Who cannot join
- History of asthma or other respiratory related disease
- Symptoms of runny nose, stuffy nose, sore throat, or sneezing due to any condition other than URTI or common cold (e.g., seasonal or perennial allergic rhinitis, sinusitis, strep throat, vasomotor rhinitis, etc.) as established by the investigator
- Clinical features of a complication of the common cold during the physical examination at screening (e.g., otitis media, sinusitis, or pneumonia) with or without the need for systemic antibiotics
- History of a severe cutaneous adverse reaction to any treatment;
- Evidence of a possible bacterial infection i.e. sinus pain, purulent nasal discharge or pleuritic pain.
- Evidence of chest infection or pneumonia
Show all 18Show fewer
- Fever greater than 39ºC (102ºF oral temperature) at the time of screening if, in the judgment of the investigator, the individual is too ill to participate in the study or the fever is due to reasons other than URTI
- Demonstrate more than two coughs to inhalation of the normal saline solution during baseline challenge
- Current smoker or individuals who have given up smoking within the past 6 months or those with >20 pack-year smoking history;
- Treatment with an ACE-inhibitor during the study or within 4 weeks prior to Screening
- History of opioid use within 1 week prior to baseline;
- Requiring concomitant therapy with prohibited medications
- History of known or suspected allergy or hypersensitivity reactions to ambroxol (e.g., asthma, urticaria or allergic type) or any of the non-medicinal ingredients contained in the study investigational product.
- Clinically significant abnormal electrocardiogram (ECG) at Screening;
- Personal or family history of congenital long QT syndrome or family history of sudden death;
- Pregnant or breastfeeding;
- Treatment with an investigational drug or biologic within 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion;
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ
About this study
Official title: A Single-Centre, Open-label, Exploratory Study of the Effect of 20 mg Ambroxol Hydrochloride on Cough Reflex Sensitivity in Patients With Acute Cough.
To assess the effect of a single doses of 20 mg ambroxol hydrochloride on cough reflex sensitivity to citric acid, capsaicin, adenosine triphosphate (ATP) and distilled water in patients with acute cough related to upper respiratory tract infection
Read the detailed description
Cough is the 5th most common presenting complaint in adults. Cough results from the stimulation of two types of afferent pathways whose receptors are located within the airway epithelium. These include rapidly adapting receptors (RARs) and C-fibre receptors. Acute as well as chronic, non-productive cough, which often follow viral upper respiratory tract infection, may result from increased sensitivity of the cough reflex. Relatively little research has been done to gain insight into the mechanisms of cough in health and disease, and to properly evaluate potential antitussive therapies. Indeed, little consensus exists regarding the optimal treatment of acute cough because of the lack of standardised outcome measures for cough. Possibly the most significant clinical need in terms of cough therapy is for the cough associated with an acute upper respiratory tract infection (URTI). Although the cough associated with URTI is often self-limiting and resolves within several days, it undoubtedly accounts for a major proportion of huge worldwide expenditure of over-the-counter (OTC) cough and cold products where patients are still struggling to find an effective medication.
This exploratory study will enable us to identify the cough challenge agent (CCA) that is most sensitive to the effect of ambroxol on cough reflex. This is expected to provide a reproducible response, to use in future studies.
This will be an open label, study in subjects with acute cough associated with URTI.
There will be a Screening/Baseline and combined Treatment visit. Subjects will return approximately 1-4 weeks after their treatment once all symptoms have subsided and the subject is no longer suffering from URTI, for a Follow-up Visit.
Up to 14 subjects with acute cough in relation to a URTI and who meet all entry criteria will be assigned to:
Treatment p.o 20 mg ambroxol lozenge (Lysopain Ambr MintM)
At Baseline and post treatment, cough sensitivity will be measured by standard clinical methodology incorporating a series of four cough challenges (citric acid, capsaicin, ATP and distilled water).
Screening/baseline visit 1a The Screening and Baseline visit will ensure that each subject meets all the specified inclusion and none of the exclusion criteria.
Treatment phase visit 1b Subjects who satisfy all entry criteria at baseline will be administered 20 mg ambroxol in the form of a lozenge which must be sucked until fully dissolved in the mouth.
The treatment will be administered in the afternoon of the same visit day as the screening/baseline assessments.
The series of abbreviated cough challenges will be conducted at 30 min and 90 min post dose.
Telephone contact Patients will be contacted by telephone once a week to determine if all symptoms associated with URTI have abated. Once this is confirmed patient will be booked in for the follow-up visit.
Follow-Up Phase Subjects will return within 4 weeks after treatment for a Follow-Up Visit once symptoms of URTI have abated. A series of full cough challenges will be performed at this vist to determine reduction in cough hypersensitivity.
- Conditions
- Cough
- Being tested
- Ambroxol Hydrochloride
- Keywords
- acute
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambroxol HydrochlorideDrug
Also called Lysopain Ambr Mint™
single lozenge of 20mg ambroxol
| Study group | Role | What they receive |
|---|---|---|
| 20 mg ambroxol | Experimental | 20 mg ambroxol lozenge delivered once on one day Receives: Drug: Ambroxol Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough reflex sensitivity
To assess the effect of single dose of 20 mg ambroxol lozenge on cough reflex sensitivity (quatified by recording the concenteration of cough stimulant evoking 2 (C2) and 5 (C5 ) coughs) to four different types of challenge agents in acute cough associated with URTI.
Measured: 8 hours
Secondary outcomes (3)
Severity of cough Visual analogue scale (VAS)
To determine the effect of single dose of 20 mg ambroxol lozenge on cough severity Visual analogue Scale from baseline compared to 30 min and 90 min post ambroxol 20 mg. The visual analogue scale will comprise of a 100mm horizontal line representing a scale of cough severity from 'No Cough' at the left hand (0 mm) end of the line up to 'Worst Cough'(100mm) at the right hand end. The participant will be instructed to draw a single vertical line on the scale to indicate how severe they felt their cough has been during a specified time.
Measured: 90 min post dose
Urge to cough Visual analogue scale (VAS)
To determine the effect of single dose of 20 mg ambroxol lozenge on urge to cough VAS from baseline compared to 30 min and 90 min post ambroxol 20 mg The Visual analogue scale will be a 100mm scale used to record the severity of their urge to cough but marked at the extremes as 'No urge-to-cough' on the left side (0mm) and 'Worst urge-to-cough' (100 mm) on the right side. The participant is instructed to draw a single vertical line on the scale to indicate how severe their urge to cough was during a specified time.
Measured: 90 min post dose
Change in cough reflex sensitivity from during acute cough to post symptom recovery
measure change in cough reflex sensitivity to citric acid, capsaicin, ATP and distilled water as measured using the C2 and C5 and compare this to that measured post symptom recovery
Measured: up tp 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start15 Feb 2018
- Primary completion19 Apr 2018
- Study completion19 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Alyn H Morice, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415269
- Sponsor's protocol ID
- IIT15419
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Open-label, Exploratory Study of the Effect of 20 mg Ambroxol Hydrochloride on Cough Reflex Sensitivity in Patients With Acute Cough.
- ClinicalTrials.gov ID
- NCT03415269
- Acronym / sponsor ID
- IIT15419
- Conditions
- Cough
- Keywords
- acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- Sanofi
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 19 Apr 2018 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effect of a single doses of 20 mg ambroxol hydrochloride on cough reflex sensitivity to citric acid, capsaicin, adenosine triphosphate (ATP) and distilled water in patients with acute cough related to upper respiratory tract infection
Detailed description
Cough is the 5th most common presenting complaint in adults. Cough results from the stimulation of two types of afferent pathways whose receptors are located within the airway epithelium. These include rapidly adapting receptors (RARs) and C-fibre receptors. Acute as well as chronic, non-productive cough, which often follow viral upper respiratory tract infection, may result from increased sensitivity of the cough reflex. Relatively little research has been done to gain insight into the mechanisms of cough in health and disease, and to properly evaluate potential antitussive therapies. Indeed, little consensus exists regarding the optimal treatment of acute cough because of the lack of standardised outcome measures for cough. Possibly the most significant clinical need in terms of cough therapy is for the cough associated with an acute upper respiratory tract infection (URTI). Although the cough associated with URTI is often self-limiting and resolves within several days, it undoubtedly accounts for a major proportion of huge worldwide expenditure of over-the-counter (OTC) cough and cold products where patients are still struggling to find an effective medication.
This exploratory study will enable us to identify the cough challenge agent (CCA) that is most sensitive to the effect of ambroxol on cough reflex. This is expected to provide a reproducible response, to use in future studies.
This will be an open label, study in subjects with acute cough associated with URTI.
There will be a Screening/Baseline and combined Treatment visit. Subjects will return approximately 1-4 weeks after their treatment once all symptoms have subsided and the subject is no longer suffering from URTI, for a Follow-up Visit.
Up to 14 subjects with acute cough in relation to a URTI and who meet all entry criteria will be assigned to:
Treatment p.o 20 mg ambroxol lozenge (Lysopain Ambr MintM)
At Baseline and post treatment, cough sensitivity will be measured by standard clinical methodology incorporating a series of four cough challenges (citric acid, capsaicin, ATP and distilled water).
Screening/baseline visit 1a The Screening and Baseline visit will ensure that each subject meets all the specified inclusion and none of the exclusion criteria.
Treatment phase visit 1b Subjects who satisfy all entry criteria at baseline will be administered 20 mg ambroxol in the form of a lozenge which must be sucked until fully dissolved in the mouth.
The treatment will be administered in the afternoon of the same visit day as the screening/baseline assessments.
The series of abbreviated cough challenges will be conducted at 30 min and 90 min post dose.
Telephone contact Patients will be contacted by telephone once a week to determine if all symptoms associated with URTI have abated. Once this is confirmed patient will be booked in for the follow-up visit.
Follow-Up Phase Subjects will return within 4 weeks after treatment for a Follow-Up Visit once symptoms of URTI have abated. A series of full cough challenges will be performed at this vist to determine reduction in cough hypersensitivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 mg ambroxol | Experimental | Drug: Ambroxol Hydrochloride20 mg ambroxol lozenge delivered once on one day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be informed of the nature of the study and have provided written informed voluntary consent;
- Be able to speak, read, and understand English;
- Be males or females, of any race, between 18 and 80 years of age, inclusive;
- Subject has an acute cough and other symptoms consistent with a common cold or an acute upper respiratory tract infection (URTI) diagnosis deemed by the investigator based on findings from medical history review, full physical examination and vital signs;
- The onset of symptoms must be within 72 h of study enrolment;
Key exclusion criteria (18 listed)
- History of asthma or other respiratory related disease
- Symptoms of runny nose, stuffy nose, sore throat, or sneezing due to any condition other than URTI or common cold (e.g., seasonal or perennial allergic rhinitis, sinusitis, strep throat, vasomotor rhinitis, etc.) as established by the investigator
- Clinical features of a complication of the common cold during the physical examination at screening (e.g., otitis media, sinusitis, or pneumonia) with or without the need for systemic antibiotics
- History of a severe cutaneous adverse reaction to any treatment;
- Evidence of a possible bacterial infection i.e. sinus pain, purulent nasal discharge or pleuritic pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambroxol HydrochlorideAlso: Lysopain Ambr Mint™single lozenge of 20mg ambroxol | Drug | 20 mg ambroxol |
Primary outcome
Cough reflex sensitivity
Time frame: 8 hours
To assess the effect of single dose of 20 mg ambroxol lozenge on cough reflex sensitivity (quatified by recording the concenteration of cough stimulant evoking 2 (C2) and 5 (C5 ) coughs) to four different types of challenge agents in acute cough associated with URTI.
3 secondary outcomes
Severity of cough Visual analogue scale (VAS)
Time frame: 90 min post dose
Urge to cough Visual analogue scale (VAS)
Time frame: 90 min post dose
Change in cough reflex sensitivity from during acute cough to post symptom recovery
Time frame: up tp 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyn H Morice principal investigator
Hull University Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ambroxol Hydrochloride in people with Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough reflex sensitivity (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.