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

August 28, 2017 updated by: Borja Cosio, Hospital Son Espases

Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08025
        • Hospital de Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Madrid, Spain, 28009
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28044
        • Hospital 12 de Octubre
      • Zaragoza, Spain, 50004
        • Hospital Miguel Servet
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07010
        • Hospital Universitario Son Espases
    • Islas Canarias
      • Santa Cruz de Tenerife, Islas Canarias, Spain, 38010
        • Hospital Universitario Nuestra Senora de la Candelaria
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Inhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.)
theophylline 100 mg, twice at day
Placebo Comparator: Control
inhaled corticosteroids and long-acting beta agonist + Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of hospitalisation
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Borja G Cosio, MD, Hospital Son Espases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (Estimate)

May 16, 2012

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on theophylline

3
Subscribe