Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease (ASSET)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
theophylline
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility 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.
Sites / Locations
- Hospital Universitario Son Espases
- Hospital Universitario Nuestra Señora de la Candelaria
- Clínica Universitaria de Navarra
- Hospital del Mar
- Hospital de Sant Pau
- Hospital Clínic de Barcelona
- Hospital Gregorio Marañón
- Fundación Jiménez Díaz
- Hospital 12 de Octubre
- Hospital Miguel Servet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Inhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.)
inhaled corticosteroids and long-acting beta agonist + Placebo
Outcomes
Primary Outcome Measures
Rate of exacerbations
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
Full Information
NCT ID
NCT01599871
First Posted
May 14, 2012
Last Updated
August 28, 2017
Sponsor
Hospital Son Espases
Collaborators
Spanish Research Center for Respiratory Diseases, Fundación Mutua Madrileña
1. Study Identification
Unique Protocol Identification Number
NCT01599871
Brief Title
Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease
Acronym
ASSET
Official Title
Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Son Espases
Collaborators
Spanish Research Center for Respiratory Diseases, Fundación Mutua Madrileña
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Inhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
inhaled corticosteroids and long-acting beta agonist + Placebo
Intervention Type
Drug
Intervention Name(s)
theophylline
Intervention Description
theophylline 100 mg, twice at day
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Rate of exacerbations
Description
Rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of hospitalisation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borja G Cosio, MD
Organizational Affiliation
Hospital Son Espases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital Universitario Nuestra Señora de la Candelaria
City
Santa Cruz de Tenerife
State/Province
Islas Canarias
ZIP/Postal Code
38010
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28044
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50004
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
27107490
Citation
Cosio BG, Shafiek H, Iglesias A, Yanez A, Cordova R, Palou A, Rodriguez-Roisin R, Peces-Barba G, Pascual S, Gea J, Sibila O, Barnes PJ, Agusti A. Oral Low-dose Theophylline on Top of Inhaled Fluticasone-Salmeterol Does Not Reduce Exacerbations in Patients With Severe COPD: A Pilot Clinical Trial. Chest. 2016 Jul;150(1):123-30. doi: 10.1016/j.chest.2016.04.011. Epub 2016 Apr 21.
Results Reference
derived
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Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease
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