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Completed

NCT Number: NCT01599871

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

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

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Key information

Conditions

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

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Son Espases, Palma de Mallorca, Balearic Islands, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Theophylline

Drug

theophylline 100 mg, twice at day

Placebo

Other

Placebo

Primary outcomes

  1. 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 outcomes

  1. Number of hospitalisation

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hospital Son Espases

Other

Collaborators

  • Fundación Mutua Madrileña
  • Spanish Research Center for Respiratory Diseases

Registry information

Official study title

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

Acronym: ASSET

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
May 16, 2012
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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