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

Chronic Obstructive Pulmonary Disease Clinical Trial

— ASSET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599871
• Other study ID #: 1559-F-447
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2012
• Last updated: August 28, 2017
• Start date: January 2011
• Est. completion date: September 2016

Study information

• Verified date: August 2017
• Source: Hospital Son Espases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• theophylline
theophylline 100 mg, twice at day

Other:
• placebo
Placebo

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Baleares
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Nuestra Señora de la Candelaria	Santa Cruz de Tenerife	Islas Canarias
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Son Espases	Fundación Mutua Madrileña, Spanish Research Center for Respiratory Diseases

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of exacerbations	Rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.	1 year
Secondary	Number of hospitalisation		1 year