Compare if once daily laba/lama treatment with two different dosages shows the same or better result on the 24 hr lungfunction than twice daily treatment of two different dosages with ICS/laba treatment. .
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FEV1 AUC 0-12h (L) response after 6 wks treatment
Secondary outcome
FEV1 AUC 0-24h (L) response after 6 wks treatment
Background summary
The COPD treatment guidelines advice treatment with bronchodilators with
different mechanisms of action. Short acting anticholinergics and
beta-2-agonists in fixed dose combinations have shown to be effective and safe
and user-friendly for patients. Once daily fixed dose combinations of
long-acting anticholinergics for the treatment COPD and will be combined with a
once daily long-acting beta-2-agonist, olodaterol. Olodaterol is being
developed for the treatment of COPD. It is expected that the combination of
these two once daily bonchodilators withdifferent mechanisms of action will
provide an optimal long term bronchodilation and is user-friendly for patients
Study objective
Compare if once daily laba/lama treatment with two different dosages shows the
same or better result on the 24 hr lungfunction than twice daily treatment of
two different dosages with ICS/laba treatment. .
Study design
randomized, double blind, double dummy, active controlled, complete crossover
(4 treatments in 4 periods)
Intervention
Once daily inhalation of study medication with the Respimat inhaler and twice
daily inhalation of the comparator with the Accuhaler (Diskus).
4 different treatment periods of 6 weeks each, separated by a washout period of
3 weeks.
Studiemedication: tiotropium + olodaterol 2,5 mcg/5 mcg solution for
inhalation, tiotropium + olodaterol 5 mcg/5 mcg solution for inhalation,
fluticasone propionate+salmeterol 250 mcg/50 mcg, fluticasone
propionate+salmeterol 500 mcg/50 mcg.
Restrictions before randomization and during test days (see E4 ).
Study burden and risks
visit 2: 2 pre dose lung function tests, 4 post dose lung function tests (up
to 3 hr after inhalation) .
Visit 4, 6, 8: 1 pre dose lung function test, 4 post dose lung function tests
(up to 3 hr after inhalation) .
visite 3, 5, 7, 9: 1 pre dose (morning dose) lung function test, 15 post dose
lung function tests (up to 24 hr after inhalation) .
At these vists the patients stay overnight in the hotel near by the hospital.
costs for meals and lodging are paid. Patients will have about 8 hour sleep
time at night during these visits.
Visit 1 and 9: ECG , bloodsampling, vital signs (bloodpressure/pulse) and
physical examination.
Patients are asked to keep a study diary to write down intake of study
medication and rescue medication.
All patients receive Ventolin for rescue medication and Atrovent (at
investigators descretion) to use during the washout period if necessary. In
each treatment period a safety phone call is made after 3 weeks.
Comeniusstraat 6
Alkmaar 1817 MS
NL
Comeniusstraat 6
Alkmaar 1817 MS
NL
Listed location countries
Age
Inclusion criteria
Written informed consent; Diagnosis of COPD; Male or female patients, 40 years of age or older; Smoking or non-smoker, smoking history of more than 10 pack years; Ability to perform requested procedures (spirometry, diary completion, inhalation of (study)medication.
Exclusion criteria
Significant disease other than COPD ; COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months before visit 1; Clinically relevant abnormal lab values; clinically relevant cardiovascular diseases; history of asthma; known active tuberculosis; pregnancy/breastfeeding; malignancies for which treatment is given in the past 5 years; history of life-threatening pulmonary obstruction; History of cystic fibrosis; Clinically evident bronchiectasis; History of significant alcohol or drug abuse; thoracotomy with pulmonary resection; oral or patch ß-adrenergics; Oral corticosteroid medication within 6 weeks prior to Visit 1; use daytime oxygen therapy for more than one hour per day; Pulmonary rehabilitation program in the six weeks prior to the screening visit; Investigational drug within one month or six half lives (whichever is greater) prior to screening visit ;Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA; Pregnant or nursing women
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-000808-41-NL |
| CCMO | NL44568.060.13 |
| Other | wordt geregistreeerd op clinical trial.gov en clinical trial.eu, nr. nog niet beschikbaar |