Chronic Obstructive Pulmonary Disease Clinical Trial
— ASSETOfficial title:
Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD
Verified date | August 2017 |
Source | Hospital Son Espases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Hospital Son Espases | Fundación Mutua Madrileña, Spanish Research Center for Respiratory Diseases |
Spain,
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 |
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