A Single Dose, Double-Blind, Double-Dummy, 3 Period Cross-Over, Placebo Controlled Clinical Trial To Assess the Rate of Onset of Action of Inhaled LAS 34273 200µg Compared To Placebo and Tiotropium 18µg in Patients with Chronic Obstructive Pulmonary Disease (COPD).
- Conditions
- Phase III placebo controlled crossover trial to better characterise the acute effect of LAS 34273 on bronchodilation action in severe COPD patients.MedDRA version: 8.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2005-005804-17-GB
- Lead Sponsor
- Almirall Prodesfarma, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 108
1. Males and non-pregnant, non-lactating females aged = 40. Women of childbearing potential are allowed to enter the trial ONLY if they use one medically approved (i.e., mechanical or pharmacological) contraceptive measures. A female is considered to be of childbearing potential unless she has had an hysterectomy, is at least one year post-menopausal or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at screening visit.
2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines:
(http://www.goldcopd.com) and stable airway obstruction.
3. Patients with a post-salbutamol FEV1 equal or greater than 30% of the predicted value and less than 50% of the predicted value (i.e., 30% = 100xobserved post-salbutamol FEV1/ predicted FEV1 <50%) FEV1 at screening visit will be measured between 30-45 min post inhalation of 400 µg of salbutamol. Predicted normal values to be used for calculation purposes are to be based on European Community for Steel and Coal predicted values (13).
4. Post-salbutamol FEV1/FVC =70% at screening visit (i.e,. 100xpost-salbutamol FEV1/FVC =70%).
5. Current, or ex-cigarette smokers with a smoking history of at least 10 packs-year.
Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-year history).
Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well.
6. Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Current or recent symptoms of asthma, allergic rhinitis or atopy (patients with past history of asthma, allergic rhinitis or atopy but without symptoms and without medication for the last 2 years could be included).
2. Eosinophil count > 600 cells/mm3.
3. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks prior to screening visit. Patients who develop a respiratory tract infection or exacerbation during the screening period will be discontinued from the trial prior to randomisation.
4. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
5. Use of long-term oxygen therapy (= 15 hours/day).
6. Clinically significant respiratory conditions defined as:
• Known active tuberculosis.
• History of interstitial lung or pulmonary thromboembolic disease.
• Pulmonary resection during the past 12 months.
• History of life-threatening COPD.
• History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc).
• Patients who in the investigator’s opinion may need pulmonary rehabilitation or a thoracotomy during the trial.
7. Clinically significant cardiovascular conditions defined as:
• Myocardial infarction during the last 6 months.
• Unstable arrhythmia which has required changes in the pharmacological therapy or other intervention during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months.
• Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.
8. Patients in whom the use of anticholinergic drugs is contraindicated: those with a known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
9. Patients with any other serious or uncontrolled physical or mental dysfunction at the discretion of the investigator which could place the patient at higher risk derived from his/her participation into the study, could confound the results of the trial or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period.
10. QTc [calculated according to Bazett’s formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at screening visit.
11. Patients who do not demonstrate to perform reproducible spirometry attempts at screening visit.
12. History of untoward reactions to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
13. Patients unable to properly use a dry powder or pMDI inhaler device or to perform spirometry.
14. Clinically relevant abnormalities in the results of laboratory, ECG parameters, other than QTc, or physical examination at the screening evaluation if the abnormality defines a disease state listed as an exclusion criterion, except for those
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method