A randomised, double blind, placebo controlled, parallel study to assess the benefits of aclidinium bromide in the relief of COPD (Chronic obstructive pulmonary disease) symptoms including cough when administered to patients with COPD
- Conditions
- Chronic obstructive pulmonary disease (COPD)MedDRA version: 17.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-004715-37-GB
- Lead Sponsor
- AstraZeneca AB; Karlebyhus, Astraallén, Södertälje SE-151 85, Sweden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 269
1. Adult male or non-pregnant, non-lactating female aged = 40. Women of childbearing potential will follow specific study requirements.
Explanatory note: A female is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year post-menopausal or has undergone tubal ligation. Women of childbearing potential are allowed to enter the trial if they show to have a negative urine pregnancy test at the Visit 1 (Screening) and are using, during the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal intra uterine devices (IUDs), sexual abstinence or vasectomy of the partner.
2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.
Explanatory note: Ex-smoker definition includes those patients who quit smoking more than 6 months prior to the Screening Visit. 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). When the patient has been smoker during several periods of time separated by inactivity periods, the total pack years resulting from several periods of smoking will be added up.
Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well.
3. Patients with a clinical diagnosis of moderate COPD, with a post bronchodilator test available within 6 months prior to Visit 1 (Screening), with FEV1 =50% and <80% and FEV1/FVC < 70%.
Explanatory note: COPD diagnosis according to GOLD guidelines 2014
4. Symptomatic patients with a CAT = 10 at Screening and Randomisation Visit (Visit 1 and 2)
Explanatory note: CAT questionnaire cannot be repeated.
5. Clinical Diagnosis of Chronic Bronchitis (defined as presence of cough and sputum production for at least 3 months in each of 2 consecutive years”)
6. Patient who is 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.
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
For inclusion and randomisation in the trial, patients must NOT meet any of the following criteria at Visit 1 (Screening) and at Visit 2 prior to randomisation.
1. History or current diagnosis of asthma.
2. Patients who suffered from a moderate or severe COPD exacerbation in the last year prior to Visit 1 (Screening) or during the run-in period.
3. Patients who develop a respiratory tract infection within 6 weeks before Visit 1 (Screening) or during the run-in period.
4. Clinically significant respiratory and cardiovascular conditions thought to be contributing to cough or likely to interfere in the conduct of the study.
5.Patient who in the investigator’s opinion may need to start a pulmonay rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.
6. Use of long-term oxygen therapy.
7. Patients in non-stable treatment with angiotensin-converting enzyme inhibitors or opiates.
Explanatory note: The above medication is allowed if taken as stable for at least two months prior to Screening Visit.
8. Patients in treatment with mucolytics, antihistamines, expectorants or antitussive drugs including over-the-counter medication.
9.Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.
Explanatory note: Patients with symptomatic sleep apnoea syndrome, any disease related with sleep disturbances such as restless-legs syndrome or somnambulism are to be excluded. However the use of continuous positive airway pressure (CPAP) is not an exclusion criteria.
10. Patient with clinically relevant abnormalities in the results of the physical examination at Visit 1 (Screening)
11. Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
12. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
Explanatory note: Patients with well-controlled, stable, asymptomatic benign prostatic hypertrophy are not excluded.
13. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
Explanatory note: active hepatitis is defined as clinical symptoms associated with chronic portal inflammation with regional necrosis and fibrosis, which may progress to nodular postnecrotic cirrhosis or patients with antibody to hepatitis B core antigen (anti-HBc) and hepatitis B surface antigen (HBsAg) test with positive results or anti-HCV antibody and HCV RIBAHCV positive tests or genetic material (RNA) testing positive results.
14. Current diagnosis of cancer other than basal or squamous cell skin cancer.
15. Patient with any other serious or uncontrolled physical or mental dysfunction.
Explanatory note: As judged by the investigator, the dysfunction could place the patient at higher risk derived from his/her participation in the study, could confound the results of the study or is likely to prevent the patient from complying with the requirements of the study or completing the study (e.g. suicidal ideation, mood disorders, personal history of overdose intake).
16. Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on in
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To assess the effect of aclidinium bromide 400 µg administered twice a day on COPD symptoms including cough in patients with moderate COPD compared to placebo.<br><br>2. To assess the effects of aclidinium bromide 400 µg administered twice a day in cough related quality of life measures when administered to the same target population.<br>;Secondary Objective: not applicable;Primary end point(s): Primary efficacy endpoint:<br>• Change from baseline in Overall E-RS Total score (i.e. score over the whole 8 weeks study period);Timepoint(s) of evaluation of this end point: score over the whole 8 weeks study period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary efficacy endpoints:<br>• Change from baseline in Overall E-RS Cough and Sputum domain score.<br>• Change from baseline in the LCQ Total score at Week 8.;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints:<br>• at Week 8<br>