Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatments theophylline, placebo
Phase phase 3
Sponsor Hospital Son Espases
Collaborator Spanish Research Center for Respiratory Diseases
Start date January 2011
End date December 2015
Trial size 128 participants
Trial identifier NCT01599871, 1559-F-447

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Inhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.)
theophylline
theophylline 100 mg, twice at day
(Placebo Comparator)
inhaled corticosteroids and long-acting beta agonist + Placebo
placebo
Placebo

Primary Outcomes

Measure
Rate of exacerbations
time frame: 1 year

Secondary Outcomes

Measure
Number of hospitalisation
time frame: 1 year

Eligibility Criteria

Male or female participants from 45 years up to 90 years old.

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.

Additional Information

Official title Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD
Principal investigator Borja G Cosio, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Hospital Son Espases.