Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 µg, 5/5 µg), tiotropium (2.5 µg, 5 µg) and olodaterol (5 µg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- chronic obstructive pulmonary diseaseCOPD10038716
- Registration Number
- NL-OMON37551
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
2. All patients must have a diagnosis of chronic obstructive pulmonary disease (P11 05865) and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 <; 80% of predicted normal and a post-bronchodilator FEV1/FVC < 70% at Visit 1.
3. Male or female patients, 40 years of age or older.
4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years
5. Patients must be able to perform a technically acceptable pulmonary function tests (spirometry), maintain records (patient paper diary) . Applicable for body plethysmography substudy only: perform technically acceptable body plethysmography measurements.
6. Patients must be able to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI).
1. Significant diseases other than COPD
2. Patients with a, in the opinion of the investigator, clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT > x2 ULN, SGPT > x2 ULN, bilirubin > x2 ULN, or creatinine > x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients).
3. Patients with a history of asthma.
4. Patients with any of the following conditions:
A diagnosis of thyrotoxicosis
A diagnosis of paroxysmal tachycardia
A history of myocardial infarction within 1 year of screening visit (Visit 1).
Unstable or life-threatening cardiac arrhythmia.
Hospitalization for heart failure within the past year.
Known active tuberculosis.
A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed).
A history of life-threatening pulmonary obstruction
A history of cystic fibrosis.
Clinically evident bronchiectasis.
A history of significant alcohol or drug abuse.
Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1).
Patients being treated with oral or patch β-adrenergics.
Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator*s opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program.
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1).
Patients with known hypersensitivity to β-adrenergic drugs, BAC, EDTA, or any other component of the RESPIMAT inhalation solution.
Pregnant or nursing women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>FEV1 AUC0-24h response [L] after 6-weeks of treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary endpoints<br /><br><br /><br>FEV1 AUC0-12h response [L] after 6-weeks treatment<br /><br>FEV1 AUC12-24h response [L] after 6-weeks treatment<br /><br><br /><br>Secondary endpoints<br /><br>Trough FEV1 response [L] after 6-weeks treatment<br /><br>Peak FEV1 responses [L] after 6-weeks treatment<br /><br>Trough FVC response [L] after 6-weeks treatment<br /><br>Peak FVC response [L] after 6-weeks treatment<br /><br>FVC AUC0-24h response [L] after 6-weeks treatment<br /><br>FVC AUC0-12h response [L] after 6-weeks treatment<br /><br>FVC AUC12-24h response [L] after 6-weeks treatment</p><br>