AsthmaNCT00159315
ATP/AMP Challenge in Healthy Non-smokers, Smokers, Patients With Asthma, and Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Inhalation Challenge with ATP and Inhalation Challenge with AMP in people with Asthma and COPD, run by Imperial College London at 1 site in United Kingdom.
Trial summary
In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12 healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve asthma; and 30 patients with mild-moderate COPD. Each subject will have 1 screening visit (if necessary) and 2 study visits. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Inhalation Challenge with ATP and Inhalation Challenge with AMP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2002to Oct 2004
- Phase
- Interventional
- 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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non-smokers (n=12)
- Normal spirometry
- Forced expiratory volume in 1 second (FEV1) reversibility of < 15% after inhaled beta2-agonists*
- At risk (current smokers) (n=12)*
- Normal spirometry, chronic symptoms (cough, sputum production)
- FEV1 reversibility of < 15% after inhaled beta2-agonists* (* = Global Strategy for the Diagnosis, Management, and Prevention of COPD)
Show all 10Show fewer
- Mild steroid-naïve asthma (n=30)
- FEV1 more than or equal to 80%
- Mild-moderate COPD (n=30)
- FEV1 50-80%
Who cannot join
- Pregnancy, breast-feeding, or planned pregnancy during the study.
- Fertile women not using acceptable contraceptive measures, as judged by the investigator
- Upper respiratory infection within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Any psychiatric condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, SW3 6LY
About this study
Official title: Adenosine 5'-Triphosphate (ATP) Challenge in Healthy Non-smokers, Current Smokers and Patients With Mild Asthma and Chronic Obstructive Pulmonary Disease (COPD)
In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12 healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve asthma; and 30 patients with mild-moderate COPD.
Each subject will have 1 screening visit (if necessary) and 2 study visits. At visits 2 and 3 the effects of adenosine 5'-triphosphate (ATP) or adenosine 5'-monophosphate (AMP) challenge, given in a random order, will be tested.
Read the detailed description
Background: Extracellular adenosine 5'-triphosphate (ATP) stimulates vagal C and Aδ fibers in the lung, resulting in pronounced bronchoconstriction and cough mediated by P2X2/3 receptors located on vagal sensory nerve terminals. We investigated the effects of nebulized ATP on cough and symptoms in control subjects, healthy smokers, and patients with COPD and compared these responses to the effects of inhaled adenosine, the metabolite of ATP.
Methods: We studied the effects of inhaled ATP and adenosine monophosphate (AMP) on airway caliber, perception of dyspnea assessed by the Borg score, cough sensitivity, and ATP in exhaled breath condensate in healthy nonsmokers (n = 10), healthy smokers (n = 14), and patients with COPD (n = 7).
Results: In comparison with healthy subjects, ATP induced more dyspnea, cough, and throat irritation in smokers and patients with COPD, and the effects of ATP were more pronounced than those of AMP. The concentration of ATP in the exhaled breath condensate of patients with COPD was elevated compared with that of healthy subjects.
Conclusions: Smokers and patients with COPD manifest hypersensitivity to extracellular ATP, which may play a mechanistic role in COPD.
- Being tested
- Inhalation Challenge with ATP, Inhalation Challenge with AMP
- Keywords
- Healthy Volunteers (smokers), Healthy Volunteers (Non-smokers), Asthma Patients, COPD Patients
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation Challenge with ATPProcedure or surgery
Inhalation Challenge with AMPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Nebulised ATP | Experimental | Not described Receives: Procedure: Inhalation Challenge with ATP; Procedure: Inhalation Challenge with AMP |
| Inhaled Adenosine | Active comparator | Not described Receives: Procedure: Inhalation Challenge with ATP; Procedure: Inhalation Challenge with AMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PC20 of ATP and AMP
PC20 of ATP and AMP
Measured: On administration
Lung function
Spirometry
Measured: On administration
Borg score
Measurement of DYSPNEA
Measured: On administration
Impulse oscillometry (IOS)
Small airway function
Measured: On administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Duska Scientific Co.
- Investigators
- Sergei A Kharitonov, MD, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159315
- Sponsor's protocol ID
- DHTABPT0336
- Status last verified
- Apr 2024
- First submitted
- 8 Sep 2005
- Last updated
- 4 Apr 2024
- Results posted
- No
Publications
Basoglu OK, Barnes PJ, Kharitonov SA, Pelleg A. Effects of Aerosolized Adenosine 5'-Triphosphate in Smokers and Patients With COPD. Chest. 2015 Aug;148(2):430-435. doi: 10.1378/chest.14-2285.
PubMed 25590209
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenosine 5'-Triphosphate (ATP) Challenge in Healthy Non-smokers, Current Smokers and Patients With Mild Asthma and Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00159315
- Acronym / sponsor ID
- DHTABPT0336
- Keywords
- Healthy Volunteers (smokers), Healthy Volunteers (Non-smokers), Asthma Patients, COPD Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Duska Scientific Co.
- Study start
- Oct 2002 (actual)
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 12 Sep 2005 (estimated)
- 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.
In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12 healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve asthma; and 30 patients with mild-moderate COPD.
Each subject will have 1 screening visit (if necessary) and 2 study visits. At visits 2 and 3 the effects of adenosine 5'-triphosphate (ATP) or adenosine 5'-monophosphate (AMP) challenge, given in a random order, will be tested.
Detailed description
Background: Extracellular adenosine 5'-triphosphate (ATP) stimulates vagal C and Aδ fibers in the lung, resulting in pronounced bronchoconstriction and cough mediated by P2X2/3 receptors located on vagal sensory nerve terminals. We investigated the effects of nebulized ATP on cough and symptoms in control subjects, healthy smokers, and patients with COPD and compared these responses to the effects of inhaled adenosine, the metabolite of ATP.
Methods: We studied the effects of inhaled ATP and adenosine monophosphate (AMP) on airway caliber, perception of dyspnea assessed by the Borg score, cough sensitivity, and ATP in exhaled breath condensate in healthy nonsmokers (n = 10), healthy smokers (n = 14), and patients with COPD (n = 7).
Results: In comparison with healthy subjects, ATP induced more dyspnea, cough, and throat irritation in smokers and patients with COPD, and the effects of ATP were more pronounced than those of AMP. The concentration of ATP in the exhaled breath condensate of patients with COPD was elevated compared with that of healthy subjects.
Conclusions: Smokers and patients with COPD manifest hypersensitivity to extracellular ATP, which may play a mechanistic role in COPD.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulised ATP | Experimental | Procedure: Inhalation Challenge with ATP, Procedure: Inhalation Challenge with AMP |
| Inhaled Adenosine | Active comparator | Procedure: Inhalation Challenge with ATP, Procedure: Inhalation Challenge with AMP |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy non-smokers (n=12)
- At risk (current smokers) (n=12)*
- Mild steroid-naïve asthma (n=30)
- Mild-moderate COPD (n=30)
Key exclusion criteria (6 listed)
- Pregnancy, breast-feeding, or planned pregnancy during the study.
- Fertile women not using acceptable contraceptive measures, as judged by the investigator
- Upper respiratory infection within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
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 |
|---|---|---|
| Inhalation Challenge with ATP | Procedure or surgery | Inhaled Adenosine, Nebulised ATP |
| Inhalation Challenge with AMP | Procedure or surgery | Inhaled Adenosine, Nebulised ATP |
Primary outcome
PC20 of ATP and AMP
Time frame: On administration
PC20 of ATP and AMP
Lung function
Time frame: On administration
Spirometry
Borg score
Time frame: On administration
Measurement of DYSPNEA
Impulse oscillometry (IOS)
Time frame: On administration
Small airway function
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 4 Apr 2024.
- Results publication: PubMed 25590209Basoglu OK, Barnes PJ, Kharitonov SA, Pelleg A. Effects of Aerosolized Adenosine 5'-Triphosphate in Smokers and Patients With COPD. Chest. 2015 Aug;148(2):430-435. doi: 10.1378/chest.14-2285.
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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.
Sergei A Kharitonov, MD, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation Challenge with ATP and Inhalation Challenge with AMP in people with Asthma and COPD, run by Imperial College London 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 10 inclusion and 6 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 4 Apr 2024. 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.
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?
PC20 of ATP and AMP (time frame: On administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159315, which also lists 1 linked publication.
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 4 Apr 2024.