Enhancement of in-Vitro GC Function in Patients With COPD

NCT00241631 | Completed Phase 2 Results

• 1 other identifier: mitHDAC#1
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator wish therefore to continue these studies on theophylline principally by conducting a small clinical pilot study on 20-30 COPD patients in a randomised, double-blind, placebo-controlled, parallel-group study.

Conditions

COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Sputum Inflammatory Cell Counts

  Supernatant collect, cell pellets count on slides

  10 weeks

Secondary Outcomes (2)

• Interleukin 8 (IL8)

  10 weeks

• Total Sputum Eosinophils

  10 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Inhaled Theophylline placebo capsule, then placebo, then active Theophylline

Drug: placebo; Drug: Theophylline

Steroid

ACTIVE COMPARATOR

Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline

Drug: Fluticasone Propionate; Drug: Theophylline

Interventions

Fluticasone Propionate DRUG

500 u

Steroid

placebo DRUG

Placebo

Theophylline DRUG

Theophylline placebo capcule

Placebo; Steroid

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an FEV1 \< 30% tend to have more severe symptom limitation and generally (though not always) find participation in a clinical trial involving 4 visits to the clinic difficult. Their airway disease is also generally less responsive to therapeutic intervention and as a consequence finding measurements which show changes to these therapeutic interventions is more difficult.
• COPD patients
• All participants will be classified to Stage 2-3 of the GOLD (Global initiative for Obstructive Lung Disease) guidelines
• Male or female, aged 45-80 years (according to GOLD guidelines)
• % \< FEV1 \< 80% predicted
• FEV1/FVC \< 70%
• Cigarette exposure of \>10 pack-years#
• With or without chronic symptoms (cough, sputum production, dyspnea).
• Steroid therapy will be stopped before run-in, but long acting bronchodilators are acceptable.
• The participants are able to give informed consent # The smoking history should include both the number smoked, for how long, and an estimate of total pack-years of smoking. One pack of 20 cigarettes smoked per day for 1 year = one pack year. Total pack years = No. cigarettes smoked per day/20 x no. years of smoking

You may not qualify if:

• Any history or evidence of asthma
• Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
• Hospital admission with respiratory infection within the last 6 months
• Upper respiratory infection within the last 4 weeks
• Participants who have received research medication within the previous one month
• Participants unable to give informed consent
• Any mental condition rendering the participant unable to understand the nature, scope and possible consequences of the study
• Known or suspected hypersensitivity to study therapy or excipients
• Participants with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
• Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant

Sponsors & Collaborators

• Imperial College London: lead
• Tanabe Pharma Corporation: collaborator
• Medical Research Council: collaborator

Study Sites (1)

Windsor chest clinic KEVII Hospital

Windsor, Berks, SL4 3DP, United Kingdom

Location

Related Publications (3)

• Ito K, Ito M, Elliott WM, Cosio B, Caramori G, Kon OM, Barczyk A, Hayashi S, Adcock IM, Hogg JC, Barnes PJ. Decreased histone deacetylase activity in chronic obstructive pulmonary disease. N Engl J Med. 2005 May 12;352(19):1967-76. doi: 10.1056/NEJMoa041892.

  PMID: 15888697 BACKGROUND

• Ford PA, Durham AL, Russell RE, Gordon F, Adcock IM, Barnes PJ. Treatment effects of low-dose theophylline combined with an inhaled corticosteroid in COPD. Chest. 2010 Jun;137(6):1338-44. doi: 10.1378/chest.09-2363. Epub 2010 Mar 18.

  PMID: 20299628 RESULT

• Kirkham PA, Whiteman M, Winyard PG, Caramori G, Gordon F, Ford PA, Barnes PJ, Adcock IM, Chung KF. Impact of theophylline/corticosteroid combination therapy on sputum hydrogen sulfide levels in patients with COPD. Eur Respir J. 2014 May;43(5):1504-6. doi: 10.1183/09031936.00131513. Epub 2014 Feb 13. No abstract available.

  PMID: 24525446 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Theophylline

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Ian M Adcock
• Organization: Imperial College London

ian.adcock@imperial.ac.uk

+44 (0)20 7594 7840

Study Officials

• ian adcock, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2005
• First Posted: October 19, 2005
• Study Start: April 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 4, 2019
• Results First Posted: December 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)