A Phase 3 interventional study of Aclidinium bromide and Aclidinium bromide in Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca. Completed at 83 sites in 2 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-01-06.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 291 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Change From Baseline (Visit 2 of lead-in Study NCT00891462, \[LAS-MD-33\]) to Week 52 (Week 64 From Start of NCT00891462, \[LAS-MD-33\]) in Morning Predose (Trough) FEV1
Time frame: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks
Change From Baseline in Peak FEV1
Change From Baseline (Visit 2 of study NCT00891462, \[LAS-MD-33\])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, \[LAS-MD-33\]).
Time frame: 52 weeks
Patient recruitment occurred from August of 2009 to March of 2010 and was by invitation only to patients who had completed study NCT00891462 (LAS-MD-33). In total, there were 77 individual study sites, 71 in the United States and 6 additional sites in Canada.
| Milestone | Aclidinium Bromide 200 μg | Aclidinium Bromide 400 μg |
|---|---|---|
| Started | 139 | 152 |
| Completed | 96 | 103 |
| Not completed | 43 | 49 |
| Withdrew: Withdrawal by subject | 12 | 19 |
| Withdrew: Adverse event | 15 | 12 |
| Withdrew: Lack of efficacy | 3 | 6 |
| Withdrew: Protocol violation | 4 | 7 |
| Withdrew: Other reason | 3 | 1 |
| Withdrew: Copd exacerbation | 4 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Inclusion/exclusion criteria | 1 | 0 |
Change From Baseline (Visit 2 of lead-in Study NCT00891462, \[LAS-MD-33\]) to Week 52 (Week 64 From Start of NCT00891462, \[LAS-MD-33\]) in Morning Predose (Trough) FEV1
| L | Placebo - Aclidinium Bromide 200 μg | Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg | Placebo - Aclidinium Bromide 400 μg | Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg |
|---|---|---|---|---|
| Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) | -0.035 ± 0.040 | 0.069 ± 0.028 | 0.069 ± 0.037 | 0.056 ± 0.025 |
Change From Baseline (Visit 2 of study NCT00891462, \[LAS-MD-33\])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, \[LAS-MD-33\]).
| L | Placebo - Aclidinium Bromide 200 μg | Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg | Placebo - Aclidinium Bromide 400 μg | Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg |
|---|---|---|---|---|
| Change From Baseline in Peak FEV1 | 0.111 ± 0.040 | 0.213 ± 0.028 | 0.222 ± 0.038 | 0.219 ± 0.025 |
Collected over Adverse Event Reporting occurred from August 2009 to November 2010 at 77 study sites (71 in the United States and 6 additional sites in Canada).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo to Aclidinium Bromide 200 μg | — | 7/44 (15.9%) | 36/44 (81.8%) |
| Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg | — | 13/93 (14%) | 63/93 (67.7%) |
| Placebo to Aclidinium Bromide 400μg | — | 7/46 (15.2%) | 28/46 (60.9%) |
| Aclidinium Bromide 400μg to Aclidinium Bromide 400μg | — | 13/106 (12.3%) | 64/106 (60.4%) |
| Event | Placebo to Aclidinium Bromide 200 μg | Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg | Placebo to Aclidinium Bromide 400μg | Aclidinium Bromide 400μg to Aclidinium Bromide 400μg |
|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/44 | 3/93 | 1/46 | 6/106 |
| PneumoniaInfections and infestations | 1/44 | 3/93 | 0/46 | 2/106 |
| Coronary artery diseaseCardiac disorders | 1/44 | 0/93 | 0/46 | 1/106 |
| DehydrationMetabolism and nutrition disorders | 1/44 | 0/93 | 0/46 | 1/106 |
| HypertensionVascular disorders | 1/44 | 0/93 | 0/46 | 1/106 |
| Acute coronary syndromeCardiac disorders | 1/44 | 0/93 | 0/46 | 0/106 |
| Carotid artery stenosisNervous system disorders | 1/44 | 0/93 | 0/46 | 0/106 |
| ConstipationGastrointestinal disorders | 1/44 | 0/93 | 0/46 | 0/106 |
| Femoral neck fractureInjury, poisoning and procedural complications | 1/44 | 0/93 | 0/46 | 0/106 |
| GastroenteritisInfections and infestations | 1/44 | 0/93 | 0/46 | 0/106 |
| Event | Placebo to Aclidinium Bromide 200 μg | Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg | Placebo to Aclidinium Bromide 400μg | Aclidinium Bromide 400μg to Aclidinium Bromide 400μg |
|---|---|---|---|---|
| Chronic obstructive pulmonary disorderRespiratory, thoracic and mediastinal disorders | 16/44 | 23/93 | 14/46 | 24/106 |
| Upper respiratory tract infectionInfections and infestations | 5/44 | 6/93 | 2/46 | 6/106 |
| SinusitisInfections and infestations | 5/44 | 6/93 | 1/46 | 3/106 |
| ContusionInjury, poisoning and procedural complications | 0/44 | 6/93 | 5/46 | 1/106 |
| NasopharyngitisInfections and infestations | 4/44 | 8/93 | 4/46 | 10/106 |
| NauseaGastrointestinal disorders | 4/44 | 1/93 | 1/46 | 2/106 |
| FatigueGeneral disorders | 4/44 | 3/93 | 0/46 | 3/106 |
| Urinary tract infectionInfections and infestations | 4/44 | 4/93 | 3/46 | 8/106 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/44 | 7/93 | 4/46 | 4/106 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/44 | 7/93 | 4/46 | 4/106 |
| Age, Continuous(years) | Aclidinium Bromide 200 μg | Aclidinium Bromide 400 μg | Total |
|---|---|---|---|
| Mean | 63.3 ± 10.1 | 64.4 ± 10.0 | 63.9 ± 9.9 |
| Age, Customized(participants) | Aclidinium Bromide 200 μg | Aclidinium Bromide 400 μg | Total |
|---|---|---|---|
| ≥ 40 to < 60 years | 49 | 40 | 89 |
| ≥ 60 to < 70 years | 51 | 67 | 118 |
| ≥ 70 years | 37 | 45 | 82 |
| Gender(Participants) | Aclidinium Bromide 200 μg | Aclidinium Bromide 400 μg | Total |
|---|---|---|---|
| Female | 63 | 76 | 139 |
| Male | 74 | 76 | 150 |
| Region of Enrollment(participants) | Aclidinium Bromide 200 μg | Aclidinium Bromide 400 μg | Total |
|---|---|---|---|
| United States | 128 | 138 | 266 |
| Canada | 9 | 14 | 23 |
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca