Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease (ASSET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hospital Son Espases
Sponsor:
Collaborators:
Spanish Research Center for Respiratory Diseases
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Borja Cosio, Hospital Son Espases
ClinicalTrials.gov Identifier:
NCT01599871
First received: May 14, 2012
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

The main objective of the study is to determine the effects of low-dose oral theophylline added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.

DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel, prospective study. Patient will be recruited during an hospitalisation due to COPD exacerbation and randomised at the time of discharge to receive theophylline 100 mg or placebo on top of combination therapy with inhaled corticosteroids and long-acting beta agonist. The rate of exacerbations will be determined every three months up to one year follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of them, the following information will be obtained:

  • Number/severity of exacerbations or hospitalisation since last clinic visit
  • Compliance and side effects
  • Blood sample
  • Plasma levels of theophylline
  • Sputum (induced)
  • MMRC
  • SGRQ
  • Forced spirometry + inspiratory capacity

    - At the beginning and at the end of the study

  • 6MWT
  • BMI
  • BODE

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: theophylline
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD

Resource links provided by NLM:


Further study details as provided by Hospital Son Espases:

Primary Outcome Measures:
  • Rate of exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.


Secondary Outcome Measures:
  • Number of hospitalisation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: January 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Inhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.)
Drug: theophylline
theophylline 100 mg, twice at day
Placebo Comparator: Control
inhaled corticosteroids and long-acting beta agonist + Placebo
Other: placebo
Placebo

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Ability to understand study procedures and to comply with them for the entire length of the study.
  • Any gender. No contraception is required neither pregnancy expected in the range of age
  • Age > 45 years
  • Smoking history > 10 pack-years (current or ex-smokers)
  • Clinical diagnosis of COPD
  • Presence of severe airflow obstruction on forced spirometry (FEV1/FVC < 0.7 and post-BD FEV1 < 50% of reference value) staged as GOLD III or IV
  • Diagnosis of COPD exacerbation on discharge.

Exclusion Criteria:

  • Presence or history of other chronic respiratory diseases (asthma, bronchiectasis, TB lesions)
  • Cancer
  • Heart failure
  • Pregnancy, or risk of pregnancy
  • Other inflammatory diseases
  • Previous treatment with theophylline
  • For drug studies: allergy/sensitivity to study drugs or their ingredients.
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599871

Contacts
Contact: Borja G Cosio, MD +34 871205050 borja.cosio@ssib.es

Locations
Spain
Hospital Universitario Son Espases Recruiting
Palma de Mallorca, Baleares, Spain, 07010
Contact    +34871205050    borja.cosio@ssib.es   
Hospital Universitario Nuestra Señora de la Candelaria Not yet recruiting
Santa Cruz de Tenerife, Islas Canarias, Spain, 38010
Clínica Universitaria de Navarra Not yet recruiting
Pamplona, Navarra, Spain, 31008
Hospital de Sant Pau Recruiting
Barcelona, Spain, 08025
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital 12 de Octubre Not yet recruiting
Madrid, Spain, 28044
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Hospital Gregorio Marañón Not yet recruiting
Madrid, Spain, 28009
Hospital Miguel Servet Not yet recruiting
Zaragoza, Spain, 50004
Sponsors and Collaborators
Hospital Son Espases
Spanish Research Center for Respiratory Diseases
Fundación Mutua Madrileña
Investigators
Principal Investigator: Borja G Cosio, MD Hospital Son Espases
  More Information

No publications provided

Responsible Party: Borja Cosio, MD, PhD, Hospital Son Espases
ClinicalTrials.gov Identifier: NCT01599871     History of Changes
Other Study ID Numbers: 1559-F-447
Study First Received: May 14, 2012
Last Updated: February 28, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Son Espases:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Theophylline
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014