Trial reportRespiratory research2017
24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD.
Trial report in Respiratory research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 3 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.
A Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo
A Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003 and Placebo MDI
Who cites it
9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 16 citations in OpenAlex.
- Network meta-analysis of the efficacy and safety of monoclonal antibodies and traditional conventional dichotomous agents for chronic obstructive pulmonary disease.Frontiers in medicine · 2024Pooled it
- Daytime symptoms of chronic obstructive pulmonary disease: a systematic review.NPJ primary care respiratory medicine · 2020Pooled it
- Once daily long-acting beta2-agonists and long-acting muscarinic antagonists in a combined inhaler versus placebo for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2019Pooled it
- An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease.Journal of aerosol medicine and pulmonary drug delivery · 2019Trial
- A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD.International journal of chronic obstructive pulmonary disease · 2018Trial
- Comparative Study on the effectiveness of Glycopyrrolate/Formoterol versus Tiotropium/Formoterol in patients with Chronic Obstructive Pulmonary Disease.Contemporary clinical trials communications · 2022Article
- Glycopyrronium/Formoterol: A Review in COPD.Drugs · 2019Review
- New developments in optimizing bronchodilator treatment of COPD: a focus on glycopyrrolate/formoterol combination formulated by co-suspension delivery technology.International journal of chronic obstructive pulmonary disease · 2018Review
- Inhaled glycopyrrolate for the treatment of chronic obstructive pulmonary disease.International journal of chronic obstructive pulmonary disease · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSymptoms of chronic obstructive pulmonary disease may vary throughout the day and it is important that therapeutic approaches provide 24-h symptom control. We report the results of two phase IIIb crossover studies, PT003011 and PT003012, investigating the 24-h lung function profile of GFF MDI (glycopyrrolate/formoterol fumarate 18/9.6 μg delivered using innovative co-suspension delivery technology) administered twice daily.
methodsPatients with moderate-to-very severe chronic obstructive pulmonary disease received 4 weeks' treatment with each of GFF MDI, placebo MDI, and open-label tiotropium (PT003011 only). Lung function was assessed over 24 h on day 29 of each treatment period. The primary outcome was forced expiratory volume in 1 second area under the curve from 0 to 24 h (FEV
resultsGFF MDI treatment significantly increased FEV
conclusionsGFF MDI significantly improved 24-h lung function versus placebo in patients with moderate-to-very severe chronic obstructive pulmonary disease, with similar benefits in the second 12-h period compared to the first, supporting twice-daily dosing of GFF MDI.
trial registrationPearl Therapeutics, Inc.; www.clinicaltrials.gov ; NCT02347072 and NCT02347085 . Registered 21 January 2015.
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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.