NCT00159315

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

September 8, 2005

Last Update Submit

April 3, 2024

Conditions

AsthmaCOPDSmoking

Keywords

Healthy Volunteers (smokers)Healthy Volunteers (Non-smokers)Asthma PatientsCOPD Patients

Outcome Measures

Primary Outcomes (4)

  • PC20 of ATP and AMP

    PC20 of ATP and AMP

    On administration

  • Lung function

    Spirometry

    On administration

  • Borg score

    Measurement of DYSPNEA

    On administration

  • Impulse oscillometry (IOS)

    Small airway function

    On administration

Study Arms (2)

Nebulised ATP

EXPERIMENTAL
Procedure: Inhalation Challenge with ATPProcedure: Inhalation Challenge with AMP

Inhaled Adenosine

ACTIVE COMPARATOR
Procedure: Inhalation Challenge with ATPProcedure: Inhalation Challenge with AMP

Interventions

Inhalation Challenge with ATPPROCEDURE
Inhaled AdenosineNebulised ATP
Inhalation Challenge with AMPPROCEDURE
Inhaled AdenosineNebulised ATP

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Mild steroid-naïve asthma (n=30)
  • FEV1 more than or equal to 80%
  • Mild-moderate COPD (n=30)
  • FEV1 50-80%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

London, SW3 6LY, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25590209RESULT

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveSmoking

Interventions

Adenosine TriphosphateAdenosine Monophosphate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Sergei A Kharitonov, MD, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

October 1, 2002

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations

GB(1)