ToAST:Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma (ToAST)

September 11, 2017 updated by: Ran Wang, National Health Service, United Kingdom

ToAST: Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma

ToAST study is a pilot study aiming to establish the safety profile of using inhaled capsaicin challenge in patients with severe asthma. The investigators will also explore the differences in cough symptoms and threshold in patients with and without bronchial thermoplasty.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

ToAST is designed as a two-visit observational study. During visit 1, written consent and measurements of baseline asthma characteristics were completed; history and examination, questionnaires (Asthma Control Questionnaires and Leicester Cough Questionnaire, and basic lung physiological assessment were performed.

At the end of visit 1, a cough monitor was attached to the subject to monitor cough frequency for the next 24 hours and this was returned at visit 2.

Visit 2 followed within two weeks after visit 1, during which a full dose capsaicin cough challenge was performed. Emergency contact details were given towards end of visit 2 should any adverse events occur.

Telephone call within 48 hours, Day 3 and Day 7: The purpose of these phone calls was to ensure that the patient had not developed any adverse effects to the capsaicin challenge.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥18
  • Person with an established diagnosis of severe asthma
  • All patients should be on British Thoracic Society (BTS) steps 4 or 5
  • Patients who have had bronchial thermoplasty (BT) should be at least 2 months after their treatment
  • Historical evidence of one of the following:
  • Airway reversibility to a short acting beta-2 agonist of ≥12%
  • Bronchial hyper-responsiveness (PC20<8mg/ml)
  • Fractional exhaled nitric oxide ≥50ppb
  • Peak flow variability >8%
  • Raised serum (≥0.45) or sputum eosinophilia (>3%)
  • Variability in spirometry over 24 months of >20%

Exclusion Criteria:

  • Unable to give informed consent
  • FEV1<50% predicted or < 1 litre
  • Known allergy or intolerance to capsaicin
  • Symptoms of upper respiratory tract infection in the last 1 month which have not resolved.
  • Lower respiratory tract infection or pneumonia in the last 6 weeks.
  • Current smoker or ex-smoker with ≥10 pack year smoking history, abstinence of ≤6 months
  • Asthma exacerbation in the previous month requiring an increase or starting of an ICS or OCS
  • Subject has changed asthma medication within the past 4 weeks prior to screening
  • A previous asthma exacerbation requiring Intensive Care Unit (ICU) admission.
  • Significant other pulmonary disorders as the major diagnosis, in particular: pulmonary embolism, pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis, emphysema or bronchiectasis.
  • Evidence of vocal cord dysfunction
  • Pregnancy or breast-feeding
  • Use of ACE inhibitors
  • Any centrally acting medication which in the view of the investigator could alter the sensitivity of the cough reflex*
  • History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Patients without BT
Other: Inhaled capsaicin cough challenge
Other: Post BT
Other: Inhaled capsaicin cough challenge

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants who has had significant fall in FEV1 (defined as >20%) within the challenge period
Time Frame: Through study completion, an average of 6 months
By measuring spirometry immediately before and after challenge
Through study completion, an average of 6 months
Number of participants who require bronchodilator treatment during capsaicin challenge period
Time Frame: Through study completion, an average of 6 months
Defined as rescue medications - 2 puffs of salbutamol inhaler via spacer
Through study completion, an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in %FEV1 predicted during capsaicin challenge period in all subjects
Time Frame: Through study completion, an average of 6 months
By measuring spirometry immediately before and after challenge
Through study completion, an average of 6 months
The tolerability of inhaled capsaicin in severe asthma
Time Frame: Through study completion, an average of 6 months
By exploring the pattern of termination of challenge in severe asthma
Through study completion, an average of 6 months
The number of adverse events in all subjects during and after capsaicin evoked cough challenge
Time Frame: Through study completion, an average of 6 months
by follow up phone calls at 48 hours, 3 days and 7 days to assess AE and SAE
Through study completion, an average of 6 months
Degree of breathlessness during capsaicin challenge period assessed by using modified Borg scale (mBorg).
Time Frame: Through study completion, an average of 6 months
By calculating Borg immediately before and after challenge to assess level of breathlessness.
Through study completion, an average of 6 months
Degree of breathlessness during capsaicin challenge period assessed by using dysnoea Visual Analogue Score (dVAS).
Time Frame: Through study completion, an average of 6 months
By calculating dVAS immediately before and after challenge to assess level of breathlessness.
Through study completion, an average of 6 months
Differences in capsaicin dose response curves (Maximum cough response evoked by any concentration of capsaicin- Emax and Capsaicin dose inducing half-maximal response - ED50) between subjects who have had BT versus those have not
Time Frame: Through study completion, an average of 6 months
by comparing post-BT and no-BT patients
Through study completion, an average of 6 months
The differences in 24-hour cough frequency between patients who have had BT and those who have not.
Time Frame: Through study completion, an average of 6 months
by comparing post-BT and no-BT patients
Through study completion, an average of 6 months
The differences in Leicester cough questionnaire (LCQ) between patients who have had BT and those who have not.
Time Frame: Through study completion, an average of 6 months
by comparing post-BT and no-BT patients
Through study completion, an average of 6 months
The differences in asthma control questionnaire(ACQ) between patients who have had BT and those who have not.
Time Frame: Through study completion, an average of 6 months
by comparing post-BT and no-BT patients
Through study completion, an average of 6 months
The differences of the dose response curves in patients with severe asthma with existing data of capsaicin challenge in patients with healthy and mild/moderate asthma (in Emax and ED50).
Time Frame: Through study completion, an average of 6 months
By comparing with existing data.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Health Service, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NHSUK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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