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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Borja Cosio, Hospital Son Espases.
Recruitment status was:  Active, not recruiting
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: August 31, 2015
Last verified: August 2015
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Borja Cosio, Hospital Son Espases:

Primary Outcome Measures:
  • Rate of exacerbations [ Time Frame: 1 year ]
    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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Spain
Hospital Universitario Son Espases
Palma de Mallorca, Baleares, Spain, 07010
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Islas Canarias, Spain, 38010
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital del Mar
Barcelona, Spain, 08003
Hospital de Sant Pau
Barcelona, Spain, 08025
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Gregorio Marañón
Madrid, Spain, 28009
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28044
Hospital Miguel Servet
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: August 31, 2015

Keywords provided by Borja Cosio, Hospital Son Espases:
COPD

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

ClinicalTrials.gov processed this record on August 22, 2017