CLINICAL TRIALS PROFILE FOR SYMBICORT

505(b)(2) Clinical Trials for Symbicort

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT00812682 ↗	Physician and Patient Perception of Adjustable Maintenance Dosing of Symbicort Turbuhaler	Completed	AstraZeneca		2006-09-01	This study will evaluate the perception of the physicians and the patients about the approved adjustable dosing of Symbicort® 160/4,5. Symbicort maintenance dose will be adjusted up and down within the approved dose range of 1x2 - 4x2 inhalations per day, to the level of asthma symptoms. Patients and physicians perception of this new dosing schedule will be evaluated by means of questionnaires completion and direct questioning.

All Clinical Trials for Symbicort

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00159263 ↗	Effect of Symbicort on GR Localisation in Asthma	Completed	AstraZeneca	N/A	2004-11-01	To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect of the study drugs on exhaled NO (bronchial and alveolar fraction.
NCT00159263 ↗	Effect of Symbicort on GR Localisation in Asthma	Completed	Imperial College London	N/A	2004-11-01	To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect of the study drugs on exhaled NO (bronchial and alveolar fraction.
NCT00206154 ↗	A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients	Completed	AstraZeneca	Phase 3	2005-04-01	The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
NCT00206167 ↗	A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD	Completed	AstraZeneca	Phase 3	2005-04-01	The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
NCT00235911 ↗	Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting	Completed	AstraZeneca	Phase 3	2003-09-01	The primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).

Clinical Trial Conditions for Symbicort

Condition Name

Condition Name for Symbicort
Intervention	Trials
Asthma	85
Chronic Obstructive Pulmonary Disease	15
Chronic Obstructive Pulmonary Disease (COPD)	6
COPD	5

Condition MeSH

Condition MeSH for Symbicort
Intervention	Trials
Asthma	82
Pulmonary Disease, Chronic Obstructive	32
Lung Diseases	32
Lung Diseases, Obstructive	31

Clinical Trial Locations for Symbicort

Trials by Country

Trials by Country for Symbicort
Location	Trials
United States	581
China	92
Japan	91
Canada	70
Germany	54

Trials by US State

Trials by US State for Symbicort
Location	Trials
California	24
Texas	24
South Carolina	22
Pennsylvania	22
Florida	21

Clinical Trial Progress for Symbicort

Clinical Trial Phase

Clinical Trial Phase for Symbicort
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	68
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Symbicort
Clinical Trial Phase	Trials
Completed	120
Unknown status	8
Terminated	8

Clinical Trial Sponsors for Symbicort

Sponsor Name

Sponsor Name for Symbicort
Sponsor	Trials
AstraZeneca	84
Orion Corporation, Orion Pharma	9
GlaxoSmithKline	6

Sponsor Type

Sponsor Type for Symbicort
Sponsor	Trials
Industry	136
Other	44

SYMBICORT: Clinical Trials, Market Analysis, and Projections

Introduction to SYMBICORT

SYMBICORT, a combination medication of budesonide (an inhaled corticosteroid) and formoterol (a long-acting beta2-adrenergic agonist), is widely used in the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). Here, we will delve into the clinical trial data, market analysis, and future projections for SYMBICORT.

Clinical Trials for SYMBICORT in COPD

Exacerbation Reduction

Clinical trials have demonstrated the efficacy of SYMBICORT in reducing COPD exacerbations. In a 12-month exacerbation clinical trial (Study 4), SYMBICORT 160/4.5 mcg significantly reduced the annual rate of moderate to severe COPD exacerbations compared to formoterol alone. The annual rate estimate was 0.68 for SYMBICORT versus 1.05 for formoterol, indicating a 35% reduction in exacerbations[1].

Lung Function Improvement

The SUN Study showed that SYMBICORT 160/4.5 mcg provided rapid and sustained improvement in lung function. By 5 minutes post-dose, 67% of the 1-hour postdose FEV1 improvement had occurred, increasing to 83% by month 6 and 84% by the end of treatment. This sustained improvement was maintained over the 12-month study period[1].

Symptom Control

SYMBICORT also demonstrated significant reductions in COPD symptom scores. In a 6-month study, SYMBICORT reduced COPD symptom scores by 97% compared to placebo and by 23% compared to formoterol alone[1].

Clinical Trials for SYMBICORT in Asthma

Rapid Onset of Action

In asthma patients, SYMBICORT showed a rapid onset of action. In a 12-week efficacy and safety study, 79% of the 2-hour postdose FEV1 improvement occurred within 15 minutes of the first dose, increasing to 89% by week 2 and 90% by the end of treatment[3].

Symptom Control and Rescue Medication Use

SYMBICORT significantly reduced the need for rescue medication in asthma patients. In a 12-week study, SYMBICORT 160/4.5 mcg reduced albuterol use by 70% within the first day and by 57% over the 12-week period compared to baseline[3].

Patient Perception

Patients taking SYMBICORT reported a faster onset of action compared to placebo. A significantly greater percentage of patients felt their medication started working right away at week 1 and maintained this perception throughout the study[3].

Market Analysis for SYMBICORT

Current Market Position

SYMBICORT remains a significant player in the respiratory market, particularly in emerging markets. Despite the entry of generic competitors, SYMBICORT continues to show strong demand, especially in China and other emerging markets[4].

Market Trends and Competitors

The global market for asthma and COPD therapeutics is projected to reach $44.1 billion by 2031, growing at a CAGR of 7.3%. While SYMBICORT faces competition from other products like GSK’s Breo Ellipta and Boehringer’s Spiriva, it maintains a strong market position. New entrants such as GSK’s Incruse Ellipta and Boehringer’s Stiolto Respimat are expected to gain market share during the forecast period[2].

Impact of Generic Competition

The entry of generic competitors has affected SYMBICORT's sales, particularly in the US. However, AstraZeneca's diversified portfolio and strong performance in other therapeutic areas have helped mitigate this impact. The company expects continued growth driven by its differentiated and growing portfolio of approved medicines[4].

Future Projections for SYMBICORT

Revenue Growth

Despite the challenges from generic competition, AstraZeneca anticipates strong growth in 2024, driven by the adoption of its medicines across geographies. SYMBICORT, although facing declines in some markets, is expected to maintain its position as a market leader in emerging markets[4].

Geographical Performance

Emerging markets, particularly China and Ex-China regions, are expected to drive growth for SYMBICORT. The strong underlying demand in these regions is likely to offset declines in other areas[4].

Competitive Landscape

The respiratory market is becoming increasingly competitive with new products and generic entrants. However, SYMBICORT's established brand and clinical efficacy are expected to help it retain market share. New products like Airsupra and other pipeline drugs from AstraZeneca will also contribute to the company's overall growth[4].

Key Takeaways

• Clinical Efficacy: SYMBICORT has demonstrated significant reductions in COPD exacerbations and improvements in lung function and symptom control in both COPD and asthma patients.
• Market Position: Despite generic competition, SYMBICORT remains a strong player in the respiratory market, especially in emerging markets.
• Future Growth: AstraZeneca expects continued growth driven by its diversified portfolio and strong demand in emerging markets.
• Competitive Landscape: The market is competitive, but SYMBICORT's established brand and clinical efficacy position it well against new entrants.

FAQs

What are the key clinical benefits of SYMBICORT in COPD?

SYMBICORT significantly reduces the annual rate of moderate to severe COPD exacerbations, improves lung function rapidly, and sustains this improvement over time.

How does SYMBICORT perform in asthma clinical trials?

SYMBICORT shows a rapid onset of action, reduces the need for rescue medication, and improves symptom control in asthma patients.

What is the current market position of SYMBICORT?

SYMBICORT remains a significant player in the respiratory market, particularly in emerging markets, despite facing competition from generic and new branded products.

How is generic competition affecting SYMBICORT's sales?

Generic competition has led to declines in SYMBICORT's sales, especially in the US, but strong demand in emerging markets helps mitigate this impact.

What are the future growth projections for SYMBICORT?

AstraZeneca expects continued growth driven by strong demand in emerging markets and the adoption of its medicines across geographies.

Sources

1. COPD Clinical Trial Data for SYMBICORT® 160/4.5 - Symbicort Touchpoints
2. Global Asthma and COPD Therapeutics Market - iHealthcare Analyst
3. Asthma Clinical Trial Data for SYMBICORT® - Symbicort Touchpoints
4. AstraZeneca FY and Q4 2023 results - AstraZeneca