Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Almirall Limited | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a new LAMA called aclidinium has been approved for use in COPD. There are potentially important differences between these two medications that might have an impact on the treatment of COPD patients.
In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD. The main comparison will be done using a very sensitive breathing test called impulse oscillometry
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium | Active Comparator | Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm. |
|
| Aclidinium | Experimental | Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug |
| ||
| Aclidinium |
| Measure | Description | Time Frame |
|---|---|---|
| Change in trough R5 from baseline after chronic dosing | 4 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF) | 4 to 6 weeks | |
| Spirometry (FEV1, FEF25-75, FVC) | 4 to 6 weeks | |
| Relaxed VC (RVC) with RVC to FVC ratio |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brina Lipworth, MD | University of Dundee | Principal Investigator |
| Arvind Deva Manoharan, MBChB | University of Dundee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma and Allergy Research Group, University of Dundee | Dundee | DD1 9SY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26758884 | Result | Manoharan A, Morrison AE, Lipworth BJ. Effects of Adding Tiotropium or Aclidinium as Triple Therapy Using Impulse Oscillometry in COPD. Lung. 2016 Apr;194(2):259-66. doi: 10.1007/s00408-015-9839-y. Epub 2016 Jan 13. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| C542859 | aclidinium bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 4 to 6 weeks |
| Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score) | 4 to 6 weeks |
| Domiciliary PIKO-6 measurements for FEV1 and FEV6 | 4 to 6 weeks |
| St. George's Respiratory Questionnaire (SGRQ) | 4 to 6 weeks |
| Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI) | 4 to 6 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |