[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of ciclesonide inhalation aerosol in healthy subjects under fasting conditions

主要目的：健康受试者空腹状态下，经口吸入给药单剂量环索奈德吸入气雾剂（受试制剂T，上海上药信谊药厂有限公司生产，规格：160μg/揿）与环索奈德吸入气雾剂（参比制剂R，Covis Pharma Gmbh生产，商品名：Alvesco®，规格：160μg/揿）后，本次试验考察空腹条件下受试制剂与参比制剂在人体内的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察受试制剂环索奈德吸入气雾剂和参比制剂环索奈德吸入气雾剂（Alvesco®）在健康受试者中的安全性。

[Translation]

Primary objective: After oral administration of a single dose of ciclesonide inhalation aerosol (test preparation T, produced by Shanghai SPH Xinyi Pharmaceutical Co., Ltd., specification: 160μg/press) and ciclesonide inhalation aerosol (reference preparation R, produced by Covis Pharma Gmbh, trade name: Alvesco®, specification: 160μg/press) to healthy subjects in the fasting state, this study investigates the absorption rate and extent of the test preparation and the reference preparation in the human body under fasting conditions, and evaluates whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation ciclesonide inhalation aerosol and the reference preparation ciclesonide inhalation aerosol (Alvesco®) in healthy subjects.

Start Date21 Nov 2024

Sponsor / Collaborator

Shanghai Sine Pharmaceutical Co. Ltd.

CTR20233942

/ CompletedNot Applicable

环索奈德气雾剂在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of ciclesonide aerosol in healthy subjects under fasting conditions

主要目的：健康受试者空腹状态下，经口吸入单次给药环索奈德气雾剂（受试制剂T，上海上药信谊药厂有限公司生产，规格：80μg/揿）与环索奈德气雾剂（参比制剂R，Covis Pharma Gmbh生产，商品名：Alvesco®，规格：80μg/揿）后，考察空腹条件下受试制剂与参比制剂在人体内的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察受试制剂环索奈德气雾剂和参比制剂环索奈德气雾剂（Alvesco®）在健康受试者中的安全性。

[Translation]

Primary objective: To investigate the absorption rate and extent of the test preparation and the reference preparation in the human body after oral inhalation of a single dose of ciclesonide aerosol (test preparation T, produced by Shanghai SPH Xinyi Pharmaceutical Co., Ltd., specification: 80μg/press) and ciclesonide aerosol (reference preparation R, produced by Covis Pharma Gmbh, trade name: Alvesco®, specification: 80μg/press) in healthy subjects under fasting conditions, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation ciclesonide aerosol and the reference preparation ciclesonide aerosol (Alvesco®) in healthy subjects.

Start Date12 Dec 2023

Sponsor / Collaborator

Shanghai Sine Pharmaceutical Co. Ltd.

EUCTR2020-002208-37-DK

/ Unknown statusPhase 2IIT

The CIMMCov-study: A Single-center, Double-blinded, Randomized, 28-days, Parallel-group, study to evaluate the effect of Ciclesonide 320 mcg inhalation twice daily versus placebo on healthcare utilization, disease progression and symptoms in the treatment of mild-to-moderate COVID-19. - CIMMCov

Start Date29 Apr 2021

Sponsor / Collaborator-

100 Clinical Results associated with Ciclesonide

100 Translational Medicine associated with Ciclesonide

100 Patents (Medical) associated with Ciclesonide

751

Literatures (Medical) associated with Ciclesonide

01 Feb 2025·THORAX

Inhaled corticosteroids and major cardiovascular events in people with chronic obstructive pulmonary disease

Article

Author: Ioannides, Anne E ; Kallis, Constantinos ; Whittaker, Hannah R ; Quint, Jennifer K

Background:

Whether inhaled corticosteroids (ICSs) reduce major adverse cardiovascular events (MACEs) in people with chronic obstructive pulmonary disease (COPD) is debated.

Objectives:

To establish, within people with COPD, (1) whether ICS reduced MACE rates (acute coronary syndrome (ACS), heart failure (HF), ischaemic strokes or cardiovascular-specific death) compared with long-acting bronchodilators; and (2) whether drug class, incident usership or patient cardiovascular history influenced the ICS-MACE relationship.

Methods:

We conducted a cohort study including patients with COPD in England, using Clinical Practice Research Datalink Aurum data, linked with Hospital Episode Statistics and Office of National Statistics death data, between 1 January 2010 and 31 December 2019. We implemented Cox proportional hazard regressions, adjusting for time interactions or using propensity score-adjusted models, as necessary. Our exposures included prescriptions of any ICS (vs any long-acting bronchodilators) and triple therapy (vs combination long-acting bronchodilators), determined during the year prior to follow-up. The outcomes of interest were MACE collectively and individual MACE subtypes.

Measurements and main results:

Among 113 353 people with COPD (mean age 67.9 years old, 53.3% male), ICS prescription was not associated with MACE (adjusted HR (95% CI)=0.98 (0.95, 1.02), p=0.41) but was associated with reduced HF, specifically, until year 6 of follow-up (average adjusted HR (95% CI)=0.91 (0.86, 0.96), p<0.001). HF reduction was driven by the ICS group containing mometasone furoate, beclomethasone, budesonide or ciclesonide (HR (95% CI)=0.89 (0.84, 0.94), p<0.001). Incident ICS use was associated with increased ACS (HR (95% CI)=1.27 (1.09, 1.47), p<0.001) but was not sustained beyond incident use. There was no association between triple therapy and MACE. Results did not differ by cardiovascular history.

Conclusions:

ICS did not reduce MACE, except HF, likely by reducing misclassified COPD exacerbations.

15 Jan 2025·The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians

Prenatal medication use in a prospective pregnancy cohort by pre-pregnancy obesity status

Article

Author: Smarr, Melissa M. ; Wing, Deborah A. ; Yeung, Edwina H. ; Vafai, Yassaman ; Gerlanc, Nicole ; Skupski, Daniel ; Sciscione, Anthony ; Ranzini, Angela C. ; Grewal, Jagteshwar ; Newman, Roger B. ; Grobman, William A. ; Sundaram, Rajeshwari ; Chien, Edward K. ; Grantz, Katherine L. ; Hinkle, Stefanie N. ; Zhang, Cuilin

BACKGROUND:

The association between obesity (body mass index (BMI) ≥ 30 kg/m²) and pattern of medication use during pregnancy in the United States is not well-studied. Higher pre-pregnancy BMI may be associated with increases or decreases in medication use across pregnancy as symptoms (e.g. reflux) or comorbidities (e.g. gestational diabetes) requiring treatment that may be associated with higher BMI could also change with advancing gestation.

OBJECTIVES:

To determine whether prenatal medication use, by the number and types of medications, varies by pre-pregnancy obesity status.

METHODS:

In a secondary data analysis of a racially/ethnically diverse prospective cohort of pregnant women with low risk for fetal abnormalities enrolled in the first trimester of pregnancy and followed to delivery (singleton, 12 United States clinical sites), free text medication data were obtained at enrollment and up to five follow-up visits and abstracted from medical records at delivery.

RESULTS:

In 436 women with obesity and 1750 women without obesity (pre-pregnancy BMI, 19-29.9 kg/m²), more than 70% of pregnant women (77% of women with and 73% of women without obesity) reported taking at least one medication during pregnancy, respectively (adjusted risk ratio (aRR)=1.10, 95% confidence interval (CI)=1.01, 1.20), with 81% reporting two and 69% reporting three or more. A total of 17 classes of medications were identified. Among medication classes consumed by at least 5% of all women, the only class that differed between women with and without obesity was hormones and synthetic substitutes (including steroids, progesterone, diabetes, and thyroid medications) in which women with obesity took more medications (11 vs. 5%, aRR = 1.9, 95% CI = 1.38, 2.61) compared to women without obesity. Within this class, a higher percentage of women with obesity took diabetes medications (2.3 vs. 0.7%) and progesterone (3.4 vs. 1.3%) than their non-obese counterparts. Similar percentages of women with and without obesity reported consuming medications in the remaining medication classes including central nervous system agents (50 and 46%), gastrointestinal drugs (43 and 40%), anti-infective agents (23 and 21%), antihistamines (20 and 17%), autonomic drugs (10 and 9%), and respiratory tract agents (7 and 6%), respectively (p > 0.05 for all adjusted comparisons). There were no differences in medication use by obesity status across gestation. Since the study exclusion criteria limited the non-obese group to women without thyroid disease, in a sensitivity analysis we excluded all women who reported thyroid medication intake and still a higher proportion of women with obesity took the hormones and synthetic substitutes class compared to women without obesity.

CONCLUSION:

Our findings suggest that pre-pregnancy obesity in otherwise healthy women is associated with a higher use of only selected medications (such as diabetes medications and progesterone) during pregnancy, while the intake of other more common medication types such as analgesics, antibiotics, and antacids does not vary by pre-pregnancy obesity status. As medication safety information for prenatal consumption is insufficient for many medications, these findings highlight the need for a more in-depth examination of factors associated with prenatal medication use.

23 Dec 2024·PNAS nexus

Physiologic and structural characterization of desisobutyryl-ciclesonide, a selective glucocorticoid receptor modulator in newborn rats

Article

Author: Chandran, Uma ; El Khoury, Nathalie ; Monaghan-Nichols, Ann Paula ; Min, Charles K ; Russo Kobylski, Robin J ; Sampath, Venkatesh ; Nettles, Kendall W ; Solt, Laura A ; Jaumotte, Juliann D ; Jano, Antalya ; Madigan, Caroline ; Dhavan, Rutu S ; Short, Kelly L ; Houtman, René ; Cole, Timothy J ; Wang, Jiefei ; Lei, Tianhua ; DeFranco, Donald B

Abstract:

Bronchopulmonary dysplasia, the most prevalent chronic lung disease of prematurity, is often treated with glucocorticoids (GCs) such as dexamethasone (DEX), but their use is encumbered with several adverse somatic, metabolic, and neurologic effects. We previously reported that systemic delivery of the GC prodrug ciclesonide (CIC) in neonatal rats activated glucocorticoid receptor (GR) transcriptional responses in lung but did not trigger multiple adverse effects caused by DEX. To determine whether limited systemic metabolism of CIC was solely responsible for its enhanced safety profile, we treated neonatal rats with its active metabolite desisobutyryl-ciclesonide (Des-CIC). DEX but not Des-CIC caused a reduction in body weight as well as reduced insulin-like growth factor-1 serum levels and chronic hyperglycemia in neonatal rats. However, Des-CIC was as effective as DEX in reducing the expression of various bleomycin-induced proinflammatory cytokine mRNAs. In vitro studies with various cell types demonstrate the potent GR transactivation and transrepression activity of Des-CIC, although genome-wide transcriptomic analyses reveal differences in DEX vs. Des-CIC responses in neonatal rat lung and liver tissue. Des-CIC is a GR super-agonist as revealed by an in vitro coregulator peptide binding assay. In addition, molecular dynamics simulations revealed unique Des-CIC-dependent allosteric signaling pathways between specific residues in the GR ligand-binding domain and receptor surfaces interacting with coregulator peptides. Thus, Des-CIC is a potential novel selective GR modulator that could impart a favorable therapeutic index for CIC use for even modest durations of GC exposure which could have long-lasting adverse somatic, metabolic, or neurologic effects.

News (Medical) associated with Ciclesonide

12 May 2023

·www.drugs.com

Get Relief With the Most Common Asthma Medications

FRIDAY, May 12, 2023 -- Receiving a diagnosis of asthma may be frightening, but learning what the treatment options are can help alleviate the anxiety that comes with diagnosis. Depending on the severity, certain asthma medications may help you manage your symptoms. Here, experts break down the most common long-term and quick-acting medications for asthma, how they work and potential side effects. Long-term medications These drugs are ones the patient takes daily as a means of controlling asthma and preventing asthma attacks. These can be in pill form or used as inhalers. Bronchodilators: Long-acting beta-2 agonists (LABA) relax the muscle bands around your airway (bronchi), making it easier to get air in and mucus out. These medications for asthma are taken twice a day through an inhaler and last up to 12 hours, according to the Cleveland Clinic . LABA medications should be given with a corticosteroid. (See combination medications below.) The main side effects of LABA medications are nervous or shaky feelings, hyperactivity, overexcitement, increased heart rate, upset stomach and trouble sleeping. Salmeterol (Serevent) Formoterol (Foradil) Long-acting muscarinic antagonists (LAMA) also relax the muscle bands around your airway, the National Heart, Lung, and Blood Institute (NHLBI) says. This asthma medication is used if the steroid/LABA combination doesn’t give enough relief. Do not use this medication if you have glaucoma or are at risk of urinary retention. Tiotropium bromide (Respimat) Theophylline. While not used often, theophylline can be useful in relaxing the airways and preventing reactions to irritants. It is taken as a pill and used for mild asthma symptoms. You may need to have blood tests drawn on a regular basis to make sure the level of medication is correct, the Mayo Clinic says. Side effects are the same as the other bronchodilators, but may also include chest pain or discomfort, dizziness, fainting, increase in urine volume or seizures. Theophylline (Theo-24, Theo-Dur, Slo-Bid, and others) Corticosteroids: Corticosteroids are steroids that reduce inflammation in the airways, according to the NHLBI. They may be taken as a pill, although very few patients are on the pill for long term. It is frequently used in an inhaler, often combined with a LABA. Side effects from the inhaled form are thrush (a mouth infection) and a hoarse voice. Inhaled corticosteroids include: Fluticasone (Flovent HFA, Arnuity Ellipta, others) Budesonide (Pulmicort Flexhaler) Mometasone (Asmanex Twisthaler) Beclomethasone (Qvar RediHaler) Ciclesonide (Alvesco) Combination asthma medications (Corticosteroid and LABA): Fluticasone and salmeterol (Advair) Budesonide and formoterol (Symbicort) Fluticasone and Vilanterol (Breo) Leukotriene modifiers reduce swelling and help keep your airways open for up to 24 hours. According to Mayo Clinic, these medications block the effects of leukotrienes, immune system chemicals that cause asthma symptoms. Side effects are uncommon, but may include nausea, headache, tiredness or diarrhea. Montelukast (Singulair) Zafirlukast (Accolate) Zileuton (Zyflo) Quick-acting asthma medications These are a group of medications that are used when a patient has a flare-up or an asthma attack. Inhaled short-acting beta2-agonists (SABAs) open the airways so air can flow through them during an asthma attack. They start working within 15 to 20 minutes and continue to work for 4 to 6 hours, according to the Cleveland Clinic. Side effects can include tremors, rapid heartbeat, allergic reactions, muscle pain, worsening breathing, dry mouth, headache, sore throat or trouble sleeping. Inhaled forms of SABA medications include: Albuterol (Ventolin) Levalbuterol (Xopenex) Albuterol and ipratropium bromide combination (DuoNeb) Corticosteroids. Oral corticosteroids are usually prescribed for short-term use to help a patient overcome a flare-up. This type of medication quickly reduces swelling and inflammation in the airways. Side effects include: Cataracts, osteoporosis, weight gain, high blood sugar, increased risk of infections, thinning bones and fractures, thin skin, bruising and slower wound healing, mood swings, depression and aggressive behavior. Prednisone (Deltasone, Prednicot, and others ) Methylprednisolone (Medrol, Solu-Medrol, Depo-Medrol) Short-acting anticholinergic bronchodilators help open the airways quickly. This medicine may be less effective than SABAs, but it is an option for people who experience side effects with other medications, the Cleveland Clinic says. Side effects you may experience with these inhalers are dry throat, eyes and nose; unusual taste; nausea and vomiting; or temporary blurred vision if the medicine gets in your eyes. Ipratropium bromide (Atrovent) Tiotropium bromide (Spiriva Respimat) Corticosteroid reliever. In January 2023, the FDA approved Airsupra, which can be used as needed to prevent bronchoconstriction and asthma attacks. In a study conducted before the approval, the risk of severe asthma exacerbation was significantly lower with a fixed-dose combination of albuterol and budesonide than with as-needed use of albuterol alone. Most common side effects are headache, oral yeast infection, cough, and difficulty speaking. Airsupra (albuterol-budesonide) Posted May 2023

Drug Approval

01 Nov 2021

·www.biospace.com

AstraZeneca Purges Two Respiratory Medicines in Big Day for Covis

Bodo Marks/picture alliance via Getty AstraZeneca’s respiratory portfolio is a little lighter as the British-Swiss pharmaceutical behemoth announced the offloading of two chronic obstructive pulmonary disease (COPD drugs) to fellow Swiss player Covis Pharma Group for $270 million. The agreement, announced November 1, involves Eklira (marketed as Tudorza in the U.S.) and Duaklir (marketed as Brimica® in some countries). The acquisition of the medicines – which netted AstraZeneca $143 million in the geographies covered under the agreement – provides a significant boost to Covis’s respiratory portfolio. COPD was the third leading cause of death worldwide in 2019, so the need and market are certainly there. “This acquisition represents a highly strategic and synergistic transaction with AstraZeneca, enabling Covis to offer a full continuum of best-in-class therapies for allergic rhinitis, asthma and COPD,” said Covis Chief Executive Officer Michael Porter in a statement. “As a result of the acquisition, Covis is firmly placed as one of the top 10 respiratory companies in the world.” Under the terms of the agreement, Covis will pay AstraZeneca $270 million upon completion of the deal, which is expected to close in quick order prior to the end of Q4 2021. In addition, Covis will be responsible for ongoing development costs related to the medicines. Eklira is a long-acting muscarinic antagonist (LAMA), while Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist. Both are presented as a dry powder for inhalation and delivered through a breath-actuated multi-dose dry powder inhaler called Genuair (Pressair in the US). AstraZeneca CEO Pascal Soriot has made no secret of his intention to steer the company's R&D pipeline to a predominantly oncology focus, and Covis is a repeat partner. In 2018, AstraZeneca divested three Asthma and Rhinitis Drugs to Covis for $350 Million. In this instance, the large multinational sold rights to Alvesco (ciclesonide), which is intended to treat persistent asthma, and Omnaris and Zetonna (ciclesonide), which are aimed at treating nasal symptoms associated with rhinitis. In April, Covis announced disappointing results from a Phase III trial evaluating Alvesco in COVID-19. The results were deemed not statistically significant, though Dr. Michael Blaiss, MD, clinical professor at the Medical College of Georgia at Augusta University in Augusta, Georgia and a member of the steering committee for the trial said that “further studies may want to look at whether this treatment may prevent or lessen post-acute COVID-19 syndrome.” AstraZeneca also said the deal will enable a sharpening of its focus on priority medicines in the respiratory and immunology space. The company went on to state in its official press release that the agreement “will ensure continued patient access to these established medicines.” With European headquarters in Zug as well as Amsterdam, Covis is a global specialty pharma company that markets therapeutics for patients with life-threatening conditions and chronic illnesses including asthma, COPD and anemia. Featured Jobs on BioSpace

Acquisition

18 Apr 2021

·www.globenewswire.com

COVIS PHARMA GROUP Announces Top-line Safety and Efficacy

ZUG, Switzerland, April 15, 2021 (GLOBE NEWSWIRE) -- Covis Pharma Group (the “Company”), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, announced today top-line results from a 400 patient phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ciclesonide metered-dose inhaler in non-hospitalized patients 12 years of age and older with symptomatic COVID-19 infection. The primary endpoint of the study was time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell, defined as symptom-free for a continuous period of ≥ 24 hours by Day 30. A sub-group analysis showed that time to alleviation of cough was the most improved symptom in the ciclesonide arm compared to the placebo arm by 6 days in 75% of the population. A relevant secondary efficacy endpoint reaching statistical significance (p=0.0301) was the 70% reduction observed in the ciclesonide arm versus 30% in the placebo arm of patients with subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19 by Day 30. There were only a small number (n=10) of total events observed in this study. No new safety signals were identified with ciclesonide 320mcg twice daily for 30 days in the active comparator arm versus placebo. In addition, no new adverse events were reported after 60 days post treatment with ciclesonide. The study randomized 400 patients in a 1:1 ratio to ciclesonide versus placebo. The study demonstrated a treatment difference between ciclesonide (70.6%) and placebo (63.5%) in the percentage of patients with an improved time to alleviation of COVID-19 related symptoms, which was not statistically significant, with a p-value of 0.5502. “We are disappointed the results were not more positive, although there was a trend toward earlier cough cessation in the ciclesonide group. Further studies may want to look at whether this treatment may prevent or lessen post-acute COVID-19 syndrome,” said Michael Blaiss, MD, clinical professor at the Medical College of Georgia at Augusta University in Augusta, Georgia, a member of the steering committee for the trial. About AlvescoAlvesco (ciclesonide) Inhalation Aerosol is a glucocorticoid indicated for the long-term treatment of asthma as maintenance therapy in adults and adolescents 12 years of age and older in the U.S. and over 6 years of age in Canada. Alvesco Inhalation Aerosol is an inhaled glucocorticoid with a small particle size (1-2 μm) enabling it to reach areas of chronic inflammation in both the large and small airways. Alvesco is not indicated for the relief of acute bronchospasm. Alvesco is not indicated for children under 12 years of age in the U.S. or under the age of 6 in Canada. Canada Indication: ALVESCO is indicated for the prophylactic management of steroid-responsive bronchial asthma in adults, adolescents and children 6 years of age and older.Contraindications: United States of America Indication: ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adults and adolescents 12 years of age and older.Important Limitations of USE: Important Safety Information for Alvesco (ciclesonide) Inhalation Aerosol Contraindications Warnings & Precautions Please read Important Safety Information and Full Prescribing Information for the US and Canada PM. About Covis Covis, with global operations in Zug, Switzerland, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at . Trademarks are the property of their respective owners. Media Contactinfo@covispharma.com

100 Deals associated with Ciclesonide

External Link

KEGG	Wiki	ATC	Drug Bank
D01703	Ciclesonide	R01AD13 R03BA08	DB01410

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Perennial	US	Covis Pharma Holdings BV	20 Oct 2006
Rhinitis, Allergic, Seasonal	US	Covis Pharma Holdings BV	20 Oct 2006
Asthma	AU	CHIESI Farmaceutici SpA	24 Feb 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	US	Covis Pharma Holdings BV	08 Jun 2020
Childhood asthma	Phase 3	BR	AstraZeneca PLC	01 Oct 2004
Childhood asthma	Phase 3	DE	AstraZeneca PLC	01 Oct 2004
Childhood asthma	Phase 3	HU	AstraZeneca PLC	01 Oct 2004
Childhood asthma	Phase 3	PL	AstraZeneca PLC	01 Oct 2004
Childhood asthma	Phase 3	PT	AstraZeneca PLC	01 Oct 2004
Childhood asthma	Phase 3	ZA	AstraZeneca PLC	01 Oct 2004
Rhinitis perennial	Phase 3	US	AstraZeneca PLC	01 Dec 2003
Seasonal rhinitis	Phase 3	US	AstraZeneca PLC	01 Dec 2003
Persistent asthma	Phase 3	-	Takeda Pharmaceutical Co., Ltd.	01 Dec 2000

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04381364 (HALT COVID-19, Pubmed \| BMJ Open)	Phase 2	COVID-19	98	Inhaled ciclesonide 320 µg	ilpgiugjjf(kqkkavwhle) = xpbxcrhdgt bmebftzdok (vvskspsmvg )	-	22 Feb 2023
				ciclesonide (Standard care)	ilpgiugjjf(kqkkavwhle) = grazbxjiws bmebftzdok (vvskspsmvg )
NCT04435795 (CONTAIN, CTgov)	Phase 2/3	COVID-19	215	Ciclesonide (Ciclesonide Inhaled and Nasal)	dhgafcpeuw(bvmxvnnsdv) = pbkondtabb rehliggvtu (axuzmfzuzp, mjhtoogriq - gejkyrxfii) View more	-	29 Apr 2022
				Normal Saline intranasal and placebo inhaler (Placebo)	dhgafcpeuw(bvmxvnnsdv) = nqqtiaevaa rehliggvtu (axuzmfzuzp, higekwpdvt - ohsksgamsd) View more
NCT00458835 (BY9010/M1-422, CTgov)	Phase 4	Rhinitis, Allergic	30	Ciclesonide (Ciclesonide Nasal Spray)	ekuojbhhhr(bfgubdlago) = bwiqxgcppw eqyvpwsdoi (eodfiipcdx, pqgmnrseec - uxxenkltwg) View more	-	02 Mar 2022
				Ciclesonide (Ciclesonide Nasal Aerosol)	ekuojbhhhr(bfgubdlago) = qqzvxcmbxo eqyvpwsdoi (eodfiipcdx, fmxluebpzk - gkikzjlfkz) View more
NCT04377711 (CTgov)	Phase 3	COVID-19	400	Ciclesonide (Group 1)	sxonoiujop(ejhgwfjpfb) = gfyjodgtqy fwmejbgolf (skrlnneazf, rthjjhcufe - qgzbmouyqw) View more	-	06 Jan 2022
				Placebo (Group 2)	sxonoiujop(ejhgwfjpfb) = bovxphzuka fwmejbgolf (skrlnneazf, cqnwfveqyy - rwqlezdzgb) View more
NCT04377711 (Pubmed \| JAMA Intern Med) Manual	Phase 3	COVID-19	400	Ciclesonide	aohmhnlnyu(dzxrvcxogz) = ktgpnlsdtj aljbcedpiw (lqcxolksfq, 14.0 - 21.0)	Negative	22 Nov 2021
				Placebo	aohmhnlnyu(dzxrvcxogz) = ljugdjutnw aljbcedpiw (lqcxolksfq, 16.0 - 23.0)
NCT04435795 (CONTAIN, Pubmed \| JAMA)	Phase 2	COVID-19	203	Inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily)	frehgjzxba(yykjdfvivz) = kxaazapsea awtdfdrryu (ntqxnakory )	Negative	02 Nov 2021
				Metered dose inhaler and nasal saline placebos	frehgjzxba(yykjdfvivz) = gnrkpwmqjj awtdfdrryu (ntqxnakory )
NCT04330586 (Pubmed \| J Clin Med) Manual	Phase 2	COVID-19	61	ciclesonide	myoxfogpvh(bocfkvdvdd) = The SARS-CoV-2 eradication rate at day 14 was significantly higher in the ciclesonide group. pwpjrqrliy (nillqflkvg ) View more	Positive	12 Aug 2021
				standard care
NCT01455194 (CONTRAST, CTgov)	Phase 3	Asthma	520	Ciclesonide (Treatment Period: Ciclesonide 160 mcg)	wfxrjbzsex(pwlequhgjg) = nisfxkudff pdsmvymhvj (paheutygxe, jycjfthmut - utwatqecgi) View more	-	25 Oct 2016
				Ciclesonide (Treatment Period: Ciclesonide 320 mcg)	wfxrjbzsex(pwlequhgjg) = yfbldeiayn pdsmvymhvj (paheutygxe, yoatzerfxq - vpjkwovjdt) View more
NCT02155881 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	80	Ciclesonide (Ciclesonide 200 mcg)	bvngmhwffi(ctfcnpbzlv) = zyyvgbepcu duloltiwzh (wixhcumwia, vexabtelpx - wxipjldjgs) View more	-	06 Oct 2016
				Ciclesonide Placebo (Placebo)	bvngmhwffi(ctfcnpbzlv) = osxmbmuirk duloltiwzh (wixhcumwia, jhlesvzkhv - uxtejfxlql) View more
NCT00384189 (RAINBOW, CTgov)	Phase 3	Asthma	1,080	Placebo+salbutamol+Ciclesonide (Ciclesonide 40 µg)	aqqglxzhmt(zilttfinxi) = cfowmrwsor fazfivwqmn (aawnkekebg, btvbszmskp - ljtyxcziae) View more	-	16 Aug 2016
				Placebo+salbutamol+Ciclesonide (Ciclesonide 80 µg)	aqqglxzhmt(zilttfinxi) = stxaubzsof fazfivwqmn (aawnkekebg, hfknvtjvpp - tbvdtrjfxh) View more

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