CASE/0552/04/25 NO BREACH OF THE CODE
COMPLAINANT v ASTRAZENECA
Allegations about a promotional video
CASE SUMMARY
This case was in relation to a section of an AstraZeneca promotional video for Trixeo (formoterol fumarate dihydrate/glycopyrronium/budesonide). that discussed a modelling study comparing the lung deposition of Trixeo with two competitor products. The complainant’s overarching allegation was that the presentation of the data was misleading, due to limitations of the model used, and that the comparison disparaged the competitor products.
The outcome under the 2024 Code was:
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No Breach of Clause 5.1
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No Breach of Clause 6.1
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No breach of Clause 6.2
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No breach of Clause 6.6
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This summary is not intended to be read in isolation.
For full details, please see the full case report below.
FULL CASE REPORT
A complaint was received about AstraZeneca UK Limited from a contactable complainant who described themselves as a health professional.
COMPLAINT
The complaint wording is reproduced below:
“A promotional video which discusses the comparison between Trixeo, Trelegy & Trimbow lung deposition is misleading. The video is titled cardiopulmonary risk - the next step to improving outcomes for patients with COPD (GB-58008, September 2025). It is available at [link provided] In the video at 25 minutes 09 seconds, the speaker [name] discusses an in silico FRI study comparing trixeo with trimbow and trelegy. The 20 patients used in this study had moderate to very severe COPD but the indication for Trelegy and Trimbow covers moderate to severe COPD patients only. The data set is not appropriate and misleading from the outset as the patient pool is not aligned to the licensed indications. All 3 inhalers within the modelling require different inhaler techniques which is not possible in modelling studies thereby leading to misleading results. The modelling does not take into account particle evaporation and deceleration which influence particle deposition and this produces inaccuracies within the results. The extra-fine particle size of Trimbow would lead to greater deposition in the smaller airways due to particle size. It is claimed during the presentation of the results at 26 minutes 40 seconds that Trixeo displayed greatest small airways deposition compared to Trimbow. This is misleading modelling as the particle size of trixeo is higher than Trimbow extra fine particle size. The speaker does not discuss the specific drawbacks of the modelling data but continues to compare the triple therapies and make claims around Trixeo superiority. The study presentation within the video is disapraging [sic] and misleading towards trimbow and trelegy. Clauses 6.1, 6.2, 5.1 & 2 are directly in breach of the ABPI code of practice.”
When writing to AstraZeneca, the PMCPA asked it to consider the requirements of Clauses 6.1, 6.2, 6.6, 5.1 and 2 of the 2024 Code.
ASTRAZENECA’S RESPONSE
The response from AstraZeneca is reproduced below:
“We are writing to you in response to your letter dated 15th April 2025, concerning a complaint from a healthcare professional (HCP) about a promotional video for Trixeo (Cardiopulmonary risk - the next step to improving outcomes for patients with COPD, available at [link provided]).
The complainant has alleged that the comparison between Trixeo, Trelegy and Trimbow lung deposition in the video is misleading for the following reasons:
1. Dataset discussed as part of in-silico Functional Respiratory Imaging (FRI) study is not appropriate and misleading as the patient pool is not aligned to the licensed indication of Trixeo, Trelegy or Trimbow.
2. Should not use inhalers with different inhaler techniques in modelling studies, as this leads to misleading results.
3. Modelling does not take into account particle evaporation and deceleration which influence particle deposition and produces inaccurate results.
4. Speaker claims that Trixeo displayed greatest small airways deposition compared to Trimbow, which is misleading as Trixeo has a larger particle size than Trimbow.
5. Speaker does not discuss drawbacks of modelling data.
6. Speaker makes claims about Trixeo superiority.
As a result, the video is disparaging towards Trelegy and Trimbow.
We will address each of the complainant’s allegations according to the relevant clauses of the ABPI Code of Practice (6.1, 6.2, 6.6, 5.1 and 2).
Background
The video subject to complaint is a webinar recording of a promotional meeting held in October 2024, for healthcare professionals (HCPs). The video is currently hosted on the Trixeo promotional website on the ‘resources’ webpage and has been live since 4th February 2025. The video is called ‘Cardiopulmonary risk: the next step to improving outcomes for patients with COPD’. The video was certified by a Medical Signatory prior to being used.
The purpose of this video is to highlight the current challenges associated with COPD management and discuss some of the ways in which these could be addressed, such as optimising existing maintenance therapy and interventions to reduce COPD exacerbations. Part of the agenda for this meeting focused on device choice, where the in-silico FRI modelling data were discussed.
The speaker was fully briefed in a video call by an AstraZeneca employee before the webinar, which included the following points:
• Information must be capable of substantiation, accurate, fair, and stated unambiguously, currently emerging evidence and opinion should be stated as such (especially where opinion remains unresolved in the scientific community), and balanced.
• All discussions must be in line with the Trixeo licence/label.
• Information must not: mislead (either directly or by implication, exaggeration, or undue emphasis), disparage (e.g. other companies, the opinions of other HCPs and HCOs), offend (through the use of imagery, poor taste or not respecting the professional standing in the audience or misrepresent.
HCPs have been directed to the on-demand videos hosted on the Trixeo webpage via email sent (by an AstraZeneca sales representative) to HCPs involved in managing patients with COPD, who have consented to receive promotional communications from AstraZeneca.
AstraZeneca Response to the allegations
1. Data set discussed as part of in silico FRI study is not appropriate and misleading as the patient pool is not aligned to the licensed indication of Trixeo, Trelegy or Trimbow.
By way of background, as stipulated by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), severity of COPD is defined by the following post-bronchodilator FEV1 values:
• Mild – FEV1 ≥ 80% predicted
• Moderate – 50% ≤ FEV1 < 80% predicted
• Severe – 30% ≤ FEV1 < 50% predicted
• Very Severe – FEV1 < 30% predicted
The indication for Trixeo, Trelegy and Trimbow (inhaled triple therapies, ITT) is maintenance treatment in patients with moderate-to-severe COPD who are inadequately controlled by dual bronchodilator therapy. The indication statement is presented on the slide in the video where ITT is first mentioned (slide 21), ensuring that it is clear to the HCP watching from outset.
In the FRI study, 15% (3/20) patients had very severe COPD. There was no comparison of results between patients with moderate, severe and very severe COPD due to the small patient numbers. Lung deposition of all 3 ITT were assessed in all patients included in the study, so data from the very severe COPD group would not have skewed the results of one therapy vs. another.
It is relevant to note that the pivotal, Phase 3 registrational trials for Trixeo, ETHOS and KRONOS included patients with moderate-to-very severe COPD. The baseline characteristics of the studies demonstrate that 11.6% and 8.1% of patients in the ETHOS and KRONOS studies, respectively, had very-severe COPD. These data are reflected in section 5.1 of the Trixeo SmPC. To note, a similar percentage of patients in IMPACT (Trelegy Phase III trial) and TRIBUTE (Trimbow Phase III trial) had very severe COPD at baseline, 16% and 20% respectively. The average % predicted FEV1 of patients in ETHOS, KRONOS and the FRI study were similar (43%, 50% and 47%, respectively), indicating similar population groups across all 3 studies. The SmPCs for all ITTs do not contraindicate use of these medicines in a population of patients with very severe COPD.
Furthermore, NICE COPD Guideline 115 does not distinguish which patients should be offered triple therapy based on COPD severity defined by FEV, and instead, recommends that HCPs assess the impact of symptoms and history of COPD exacerbations to determine eligibility for these inhaled combination medicines.
We do not agree that discussion of the FRI study in this promotional video is inconsistent with the SmPC for the following reasons:
1. The indication statement for ITT was presented in the slide deck at first mention of ITT, so HCPs were clear about this from outset.
2. Small proportion (15%, n=3) of very severe COPD patients were included in the study.
3. The SmPC does not state that triple therapies should not be prescribed to patients with very severe COPD. This is also reflected in national clinical guidelines.
In Case AUTH/2569/12/12, the panel ruled that presenting study results with a small proportion of the population not aligned to the licensed indication was not inconsistent with the SmPC.
2. Should not use inhalers with different inhaler techniques in modelling studies, as this leads to misleading results.
FRI is a recognised methodology to evaluate particle deposition in the lungs and is supported by numerous peer-reviewed publications. Studies have demonstrated that FRI has comparable findings to the gold standard of in-vivo lung scintigraphy across different delivery models, including pMDI and DPI. FRI methodology is often preferred to scintigraphy as patients are exposed to lower radiation loads.
We therefore ascertain that using inhalers with different inhaler techniques in FRI modelling studies does not lead to misleading results.
3. Modelling does not take into account particle evaporation and deceleration which influence particle deposition and produces inaccurate results.
As outlined above in response to allegation (2), FRI methodology is a recognised and robust way to assess lung deposition. We do not agree that it produces inaccurate results.
4. Speaker claims that Trixeo displayed greatest small airways deposition compared to Trimbow, which is misleading as Trixeo has a larger particle size than Trimbow.
Trixeo has a particle size of 3µm and Trimbow has a particle size of 1.1µm, both of which are within the optimal range of 1-5µm for depositing throughout the lungs, including the small airways. Trixeo has a higher fine particle fraction than Trelegy and Trimbow.
Particle size is only one factor that can influence lung deposition. Other factors such as fine particle fraction, geometric SD and plume characteristics can also significantly influence deposition. As lung deposition is not only a factor of particle size, the complainant’s conclusion is not correct.
Based on this, we do not agree that this finding is misleading.
5. Speaker does not discuss drawbacks of modelling data.
It was made sufficiently clear that further research was needed to understand whether this data would translate into clinical benefits, as shown as an example on the slide below. This prominent black box appears on slides 40-42 while the results of the FRI study is discussed.
[Screenshot provided]
It is also relevant to note that the HCP states (at 26m 01s) that “It’s a model, it’s not in real life. So, we have to take this information with the constraints it has”.
Based on the above, we believe it is sufficiently clear that the data presented has limitations, and the HCP would not have been misled about its meaning.
6. Speaker makes claims about Trixeo superiority and is disparaging to Trelegy and Trimbow.
As described above, the speaker presents the results of the FRI study, whilst making it clear that further research is needed to understand the clinical impact. The information has been presented in a factual and balanced way. We therefore do not agree that it is disparaging to Trelegy and Trimbow.
We therefore refute alleged breach of clauses 6.1, 6.2, 6.6, 5.1 and 2 of the ABPI Code of Practice.
Summary of AstraZeneca’s position
It is AstraZeneca’s position that:
1. The presentation of the in-silico FRI modelling study in the video is not misleading.
2. The video is not disparaging towards Trelegy and Trimbow.
AstraZeneca is committed to the letter and spirit of the ABPI Code of Practice and takes its responsibilities under the Code very seriously.”
PANEL RULING
This complaint concerned a recording of a promotional video hosted on the “resources” page on a promotional website for Trixeo (formoterol fumarate dihydrate/glycopyrronium/budesonide). Trixeo was a single-inhaler triple therapy indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who were not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta-2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA).
AstraZeneca submitted that the purpose of the video was to highlight the challenges associated with COPD management and discuss ways in which it could be addressed.
The Panel noted that the promotional video was titled “Cardiopulmonary risk – the next step to improving outcomes for patients with COPD” and that the allegations concerned a section of the video that discussed an in silico functional respiratory imaging (FRI) modelling study comparing the lung deposition of Trixeo with Trimbow (beclometasone/formoterol/ glycopyrronium) and Trelegy (fluticasone furoate/vilanterol/umeclidinium).
The complainant’s overarching allegation appeared to be that the presentation of the FRI study data was misleading. The Panel summarised the complainant’s concerns, in this regard, as follows:
1. The in silico FRI study data presented was not aligned with the licensed indication
2. All three inhalers required different inhaler techniques which were not suitable to be included in modelling studies
3. The modelling data did not take into account particle evaporation and deceleration which influence particle deposition
4. The claim that Trixeo displayed the greatest small airways deposition compared to Trimbow was misleading as the particle size of Trixeo was higher than Trimbow
5. The speaker did not discuss the specific drawbacks of the modelling data but compared triple therapies and made claims around Trixeo superiority.
The Panel considered each in turn and further considered whether the study presentation was disparaging and misleading towards Trimbow and Trelegy as alleged.
1. The in silico FRI study data presented was not aligned with the licensed indication
The Panel noted the complainant’s concern that the FRI study, referred to from
25 minutes 09 seconds onwards, included patients with moderate to very severe COPD but that the licensed indication for each product only covered moderate to severe COPD patients.
AstraZeneca submitted that the indication for Trixeo was presented in the slide deck at the first mention of inhaled triple therapies so that health professionals were clear at the outset, which the Panel observed was presented 12 minutes into the video.
Section 4.1 (Therapeutic indications) of the Trixeo summary of product characteristics (SPC) specified that it was “indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).”
Section 5.1 (Pharmacodynamic properties) of the SPC referred to, among other things, the ETHOS and KRONOS trials which compared inhalers for a patient population with moderate to very severe COPD.
In this regard, the Panel took account of AstraZeneca’s submission that 11.6% and 8.1% of patients in the ETHOS and KRONOS studies, which were pivotal registrational trials, had very severe COPD at baseline. 15% of patients with very severe COPD (n=3) were included in the FRI study in question. The Panel further noted AstraZeneca’s submission that the SPCs for all inhaled triple therapies did not contradict their use in patients with very severe COPD and that the NICE guidelines did not distinguish which patients should be offered triple therapy based on COPD severity.
In the Panel’s view, while it would have been helpful for the presentation to have explicitly clarified the licensed indication when discussing the modelling data, it had not been established that the inclusion of a small proportion of patients with very severe COPD rendered the reference to the in silico FRI study misleading in the particular circumstances of this case. The complainant bore the burden of proof and it had not been established that the presentation of the study meant that Trixeo had been promoted in a manner that was inconsistent with its licensed indication, such that the information presented was inaccurate and misleading as alleged.
2: All three inhalers required different inhaler techniques which were not suitable to be included in modelling studies
The complainant alleged that the use of inhalers requiring different inhaler techniques within the in silico modelling study rendered the results misleading.
The Panel noted AstraZeneca’s submission that FRI was a recognised methodology to evaluate particle deposition in the lungs and that FRI had “comparable findings to the gold standard of in-vivo lung scintigraphy across different delivery models including pMDI and DPI”.
The Panel was not an investigatory body and it judged complaints on the evidence provided by both parties. The Panel did not consider that the complainant had established that the use of different inhaler techniques within the modelling study rendered the results, or presentation, misleading. It was not the role of the Panel to assess the suitability of the in silico FRI study methodology.
3. Modelling data did not take into account particle evaporation and deceleration which influence particle deposition
In relation to the allegation that the model produced inaccurate results as it did not take account of particle evaporation and declaration, the Panel noted AstraZeneca’s submission, as above, that FRI methodology was a recognised and robust way to assess lung deposition. The Panel considered it had not been established that this rendered the presentation inaccurate or misleading. It was not the role of the Panel to assess the suitability of the in silico FRI study methodology.
4. The claim that Trixeo displayed the greatest small airways deposition compared to Trimbow was misleading as the particle size of Trixeo was higher than Trimbow
The Panel observed the claim at issue, at 26 minutes and 40 seconds of the video, was the heading of slide 41 “TRIXEO displayed the greatest regional small airways deposition versus Trimbow and Trelegy.”
The slide included a graph comparing the percentage of delivered dose deposited in the small airways for all three inhalers, beneath which was a box that included the bullet point: “TRIXEO had the greatest overall ICS small airways deposition (31.2%) versus Trimbow (26.5%) and Trelegy (10.6%).” To the right of the slide was the boxed statement “Further research is needed to understand if the differences in deposition observed in in silico image modelling studies translate into clinical benefits.” The Panel noted that, in presenting this slide, the speaker stated that within the model, Trixeo “deposits more drug in the smaller airways.”
The Panel took account of AstraZeneca’s submission that particle size was only one factor amongst others that would influence lung deposition and that while Trixeo had a particle size of 3μm compared to 1.1μm for Trimbow, both of these figures were within the optimum particle range of 1-5μm for depositing throughout the lungs, which included small airways.
In the Panel’s view, the complainant’s assertion was that particle size alone determined small airway deposition which did not appear to be so on the evidence before it. The Panel therefore considered it had not been established that the claim presented was inaccurate or misleading on this basis.
5. The speaker did not discuss the specific drawbacks of the data but compared triple therapies and made claims around Trixeo superiority
The Panel noted that the section of the video at issue that related to the FRI study lasted approximately one and a half minutes and formed one component of a broader presentation.
The Panel took account of the speaker’s comments during the presentation, including that the information was based on “a model, not real life”, that the findings should be interpreted “with the constraints it has”, and that it was not known “exactly what this means in clinical practice”. The Panel further recognised that slides 40-42 included a prominent blue box on the right-hand side which read “further research is needed to understand if the differences in deposition observed in in silico image modelling studies translate into clinical benefits.”
While it would have been helpful for the limitations of the modelling approach to have been discussed, along with the specific drawbacks of the study referred to, the Panel considered the written and verbal caveats were sufficient to alert the audience to the nature of the data being presented. Taking this into account, along with the fact that the section constituted a limited part of a broader presentation, the Panel considered it had not been established that the presentation of the modelling data misleading implied Trixeo superiority.
Misleading presentation of the data (Clauses 6.1 and 6.2)
In making its ruling, the Panel considered the complainant’s overarching allegation to be that the presentation of the in silico FRI study was misleading, based on the cumulative effect of its concerns above.
The Panel noted its comments for each point and took into account the broader context that the focus of the promotional video was to highlight the challenges associated with COPD management and discuss ways in which it could be addressed, rather than a review of the FRI modelling study. The Panel considered that the approximately one and a half minute presentation of the FRI study made clear that the data was derived from a model rather than clinical studies, that there were “constraints” and that further research was required to understand the clinical relevance. The Panel further reiterated that it was not for it to assess the suitability of the in silico FRI study methodology.
Within the context of the video as a whole and on the evidence before it, the Panel considered that the complainant had failed to establish that the presentation of the modelling data was misleading or inaccurate. The Panel therefore ruled no breach of Clauses 6.1 and 6.2.
Disparaging and misleading towards Trimbow and Trelegy (Clause 6.6)
The Panel understood the complainant’s allegation of disparagement to be founded on the assertion that the FRI modelling data constituted a misleading comparison with Trimbow and Trelegy. In this regard, the Panel noted slides 40-42 depicted a direct comparison of all three inhalers and referred to each by brand name. The speaker’s commentary in relation to these slides described the results of the in silico model including that, within the model, “the drug deposited more in this model in the Trixeo inhaled therapy than the other single inhaled triple therapy.” It was clear to the Panel that the statement was a direct comparison and did not extend beyond the presentation of the modelling data.
The Panel further noted that earlier in the presentation, slide 22 listed the three single-inhaler triple therapies available on the market using the non-proprietary name and corresponding company only and that the speaker stated that these inhalers “were very effective in improving outcomes” for COPD patients.
Clause 6.6 required that the medicines, products and activities of other pharmaceutical companies must not be disparaged.
The Panel took account of its determination above that it had not been established that the presentation of the FRI modelling data was inaccurate or misleading and determined there was no evidence that Trimbow or Trelegy had been disparaged. In reaching its determination, the Panel considered that references of the comparator products appeared to be confined to the presentation of modelling results and were not accompanied by disparaging content or commentary. The Panel therefore ruled no breach of Clause 6.6.
Overall
The complainant cited breaches of Clauses 5.1 and 2 in relation to this matter but made no additional allegations specific to these clauses.
Noting its rulings of no breaches above, the Panel did not consider that the circumstances of this case indicated that high standards had not been maintained, nor that AstraZeneca had brought discredit upon, or reduced confidence in, the pharmaceutical industry. The Panel therefore ruled no breach of Clause 5.1 and no breach of Clause 2.
Complaint received 14 April 2025
Case completed 8 January 2026
