Trial reportClinical drug investigation2013
ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients.
Trial report in Clinical drug investigation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Efficacy and cardiovascular safety of LAMA in patients with COPD: a systematic review and meta-analysis.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2021Pooled it
- Dual combination therapy versus long-acting bronchodilators alone for chronic obstructive pulmonary disease (COPD): a systematic review and network meta-analysis.The Cochrane database of systematic reviews · 2018Pooled it
- Comparative efficacy of long-acting muscarinic antagonist monotherapies in COPD: a systematic review and network meta-analysis.International journal of chronic obstructive pulmonary disease · 2015Pooled it
- Aclidinium bromide for stable chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2014Pooled it
- Comparative efficacy of inhaled medications (ICS/LABA, LAMA, LAMA/LABA and SAMA) for COPD: a systematic review and network meta-analysis.International journal of chronic obstructive pulmonary diseasePooled it
- Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.International journal of chronic obstructive pulmonary disease · 2024Trial
- Efficacy and safety of twice-daily glycopyrrolate in patients with stable, symptomatic COPD with moderate-to-severe airflow limitation: the GEM1 study.International journal of chronic obstructive pulmonary disease · 2016Trial
- Effect of aclidinium bromide therapy on quality of life and symptoms of patients with chronic obstructive pulmonary disease: pooled analysis results of the Greek and Austrian ON-AIR real-world observational studies.BMC pulmonary medicine · 2026Observational
- The Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide 400 μg Administered by Inhalation as Single and Multiple (Twice Daily) Doses in Healthy Chinese Participants.International journal of chronic obstructive pulmonary disease · 2023Article
- Characteristics of New Users of Aclidinium Bromide, Aclidinium/Formoterol, and Other COPD Medications in the United Kingdom, Denmark, and Germany.Clinical drug investigation · 2022Article
- A Real-World Observational Study Examining the Impact of Aclidinium Bromide Therapy on the Quality of Life, Symptoms, and Activity Impairment of Patients with Chronic Obstructive Pulmonary Disease: The Greek ON-AIR Study.International journal of chronic obstructive pulmonary disease · 2020Observational
- Long-Term Evaluation of the Effects of Aclidinium Bromide on Major Adverse Cardiovascular Events and COPD Exacerbations in Patients with Moderate to Very Severe COPD: Rationale and Design of the ASCENT COPD Study.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2018Article
- Review
- Is aclidinium alone or combined with a LABA a rational choice for symptomatic COPD patients?Respiratory research · 2017Review
- Article
- Efficacy and Safety of Twice-Daily Glycopyrrolate Versus Placebo in Patients With COPD: The GEM2 Study.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2016Article
- Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials.BMJ open respiratory research · 2016Article
- Overall and Cardiovascular Safety of Aclidinium Bromide in Patients With COPD: A Pooled Analysis of Six Phase III, Placebo-Controlled, Randomized Studies.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2015Article
- Patient-reported outcomes and considerations in the management of COPD: focus on aclidinium.Patient preference and adherence · 2015Article
- Positioning new pharmacotherapies for COPD.International journal of chronic obstructive pulmonary disease · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesAclidinium bromide is a long-acting muscarinic antagonist approved for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). This 12-week phase III study evaluated efficacy and tolerability of aclidinium 200 or 400 μg in patients with moderate-to-severe COPD.
methodsIn this double-blind study, 544 patients with COPD were randomized to placebo or twice-daily aclidinium 200 or 400 μg administered by Genuair(®)/Pressair(®). Lung function, health status [measured by the St. George's Respiratory Questionnaire (SGRQ)], dyspnea [measured using the Transition Dyspnea Index (TDI)], and safety were assessed throughout the study.
resultsMean changes from baseline in morning trough forced expiratory volume in 1 s (FEV(1)) at week 12 (primary endpoint) were significantly higher for aclidinium than for placebo (200 μg, 51 mL; 400 μg, 72 mL; both p < 0.05). Aclidinium also significantly improved other lung function outcomes. At week 12, improvements from baseline were observed with aclidinium in SGRQ total score (200 μg, -6.0; 400 μg, -5.4) and TDI focal score (200 μg, 1.0; 400 μg, 1.3). Furthermore, clinically important improvements in SGRQ total and TDI focal scores were achieved by 45 and 51 % of patients, respectively, who received aclidinium 400 μg, with a significant difference versus placebo for TDI (p < 0.05). Anticholinergic-related adverse events (e.g., dry mouth) were infrequent, occurring <2 % for any event in any treatment group. Both aclidinium doses were well tolerated.
conclusionThis study demonstrates efficacy and safety of aclidinium in COPD patients. Unexpected baseline imbalances between treatment groups may have impacted the aclidinium treatment benefit in this study.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.