Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Symptoms and General Pathology

Lung Neoplasms

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Respiratory Tract Neoplasms

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Lung Diseases

Respiratory Tract Diseases

Anti-Inflammatory Agents

Respiratory System Agents

All Drugs and Chemicals

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Budesonide

Ipratropium

Terbutaline

Bronchodilator Agents

Anti-Asthmatic Agents

Glucocorticoids

Hormones

Hormone Antagonists

+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID

To test the hypothesis that nebulizer Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two arms among primary lung cancer patients with COPD required single lobectomy from 3 days before operation to 7 days after operation.

Xiuyi Zhi, Professor

To test the hypothesis that nebulized Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two treatment arms among primary lung cancer patients with COPD required single lobectomy from 3days before operation to 7 days after operation.

Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD

Efficacy of Nebulized Pulmicort Respules on Post Operation Pulmonary Complication During Pulmonary Single Lobectomy Surgery in Primary Lung Cancer Patients With COPD

Definition of post-operation pulmonary complication:

1. Pneumonia/other pulmonary infections, with X-ray evidence, fever and/or WBC\>15,000mL
2. Sputum retention:classified as purulent and the pour ability grade is 1 or 2
3. Acute respiratory failture or chronic respiratory failture
4. Atelectasis
5. Aerothorax:\>30% by X-ray; pulmonary embolism

Xiuyi Zhi

Professor

Infections

Ear, Nose, and Throat Diseases

Digestive System Diseases

Mouth and Tooth Diseases

Rare Diseases

Rhinosinusitis

Nasal Polyps

Sinusitis

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Rhinitis

Communicable Diseases

Respiratory Tract Infections

Paranasal Sinus Diseases

Nose Diseases

Otorhinolaryngologic Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Chronic Graft Versus Host Disease

Pharmaceutical Solutions

Buparid 1 mg budesonide/2 ml nebuliser solution

Budes® Nasal Spray 50 µg budesonide/pump

Sven Becker, MD

The study should create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the selected parameter should allow a correlation between an objective methodology and the clinical outcome of the study patients.

Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi

A Pilot Study to Investigate the Efficacy and Safety of Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis (CRS) With Polyposis Nasi in Adult Patients

Health-specific quality of life was assessed by means of the self-rated, 22-item Sino-Nasal Outcome Test (SNOT-22). The SNOT-22 total score has a (theoretical) range of 0 - 110 points, with higher scores indicating more severe impairment.

Presented are the mean values of the SNOT-22 total score after 24 weeks minus value at day 0 (baseline).

Nasal obstruction was assessed using the method of rhinomanometry by measuring the positive nasal inspiratory flow (PNIF). For the assessment the subject had to inhale maximally through the nose three times and the highest value of flow rate was recorded after 4 weeks and 8 weeks of treatment.

Inflammation of the nasal mucosa and paranasal sinus was assessed using the Lund-Mackay score based on magnetic resonance imaging. The score can take on values between 0 and 24 points, with higher values indicating more severe impairment. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.

Treatment-emergent adverse events (AEs) Each participant has been monitored for adverse events up to 26 weeks. All patients withdrawn from the study will be followed-up for AEs or SAEs for further 2 weeks or 4 weeks, respectively.

Pari Pharma GmbH

Buparid 1 mg budesonide/2 ml nebuliser solution

Budesonide: Inhalation

Buparid; Treatment A

Budes® Nasal Spray 50 µg budesonide/pump

Budesonide: Nasal spray

Budes; Treatment B

Total

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Germany

Region of Enrollment

Friedrich gruber

Change of Inflammation of the Nasal Mucosa and Paranasal Sinus

Safety Assessment

Health-specific Quality of Life

Mean flow rate after 4 weeks

Mean flow rate after 8 weeks

Nasal Obstruction

Overall Study

Carcinoma, Non-Small-Cell Lung

Respiratory Aspiration

Small Cell Lung Carcinoma

Small Cell Lung Cancer

budesonide

Stephen Lam, MD

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of budesonide may be an effective way to prevent bronchial dysplasia.

PURPOSE: Randomized double-blinded phase II trial to determine the effectiveness of budesonide in treating former or current smokers who have bronchial dysplasia.

OBJECTIVES: I. Determine the efficacy of inhaled budesonide on the number and grade of bronchial epithelial dysplastic lesions in former and current smokers. II. Compare the effect of inhaled budesonide vs placebo in modulating several intermediate biomarkers (i.e., proliferation, apoptosis, morphometric, and methylation markers) in this patient population. III. Correlate the regression of bronchial dysplasia (number and grade) and improvement in sputum cytology (morphometric grade of atypical cells) with the modulations in molecular biomarkers in this patient population. IV. Compare the stability of the chemopreventive effect of these treatment regimens at six months after completion of these regimens in these patients. V. Compare the safety of these treatment regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender, smoking status (current vs former), and morphometric index (no greater than 3.4 vs greater than 3.4). Patients are randomized into one of two treatment arms. Arm I: Patients receive inhaled budesonide twice daily. Arm II: Patients receive an inhaled placebo twice daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at 7 months and 12 months.

PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 15 months.

Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia

A Phase II Trial of Inhaled Budesonide (Pulmicort Turbuhaler) in Persons With Dysplasia of the Bronchial Epithelium

National Cancer Institute (NCI)

British Columbia Cancer Agency

Antineoplastic Agents

Prednisone

Antineoplastic Agents, Hormonal

1mg/2ml Pulmicort Respules BIS twice daily

Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. This study aimed to evaluate the efficacy and safety of a short course of budesonide inhalation suspension via transnasal nebulization in the preoperative management of chronic rhinosinusitis with nasal polyposis. The second aim was to compare budesonide inhalation suspension with budesonide aqueous nasal spray and oral prednisone in nasal polyp treatment.

Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.

Efficacy and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization Compared With Budesonide Aqueous Nasal Spray and Oral Steroids for the Treatment of Chronic Rhinosinusitis With Polyposis.

The primary efficacy outcome measure was the patients' assessment of four major symptoms improvement on an ordinal scaled visual analogue score of 0 to 10, where 0 indicates that no symptom is present and 10 signifies the presence of the most severe nasal obstruction, rhinorrhea, alteration in the sense of smell and headache/ facial pain.

the physicians' assessment of nasal polyp size reduction by endoscopic examination according to Kennedy score (0, no polyps; 1, polyps in the middle meatus, not reaching below the inferior border of the middle turbinate; 2, polyps reaching below the inferior border of the middle turbinate, but not below the inferior border of the inferior turbinate; 3, large polyps reaching below the inferior turbinate). Bilateral polyp grade was obtained as the sum of the individual grades for the left and right nasal cavities. A total score of 0-6 is possible.

Beijing Tongren Hospital

Inhaled Budesonide 800 ug twice daily for 1 year

Inhaled Budesonide 800 micrograms (ug) twice daily for one year.

Inhaled placebo twice daily for one year.

Placebo

Giulia Veronesi, MD

Scott M. Lippman, MD, FACP

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.

PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.

OBJECTIVES:

Primary

* Evaluate the effect, in terms of size and number reduction of computed tomography (CT) scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo.

Secondary

* Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo.
* Correlate the modulation of biological markers of lung cancer in serum and sputum after treatment with the modification of lung nodules sizes.
* Determine treatment toxicity, side effects, and safety of inhaled budesonide.
* Evaluate the role of CT scans in estimating the grade of respiratory impairment and emphysema.
* Determine the effect of inhaled budesonide on respiratory function before and after treatment.

OUTLINE: This is a randomized, double-blind, placebo controlled study.

Participants are stratified according to gender, smoking habit (current vs former smoker), and nodule characteristics (solid vs semisolid or non-solid). Participants are randomized into 1 of 2 treatment arms.

* Arm I: Subjects receive inhaled budesonide twice daily for 1 year in the absence of unacceptable toxicity.
* Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity.

Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies.

After completion of study therapy, subjects are followed at 1 month and continue CT scan screening.

PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer

Randomized Phase II Trial of Budesonide Turbuhaler® 800 Micrograms/Twice Daily Versus Placebo in High-Risk Population With Undetermined Lung Nodules Detected at Screening Low Dose CT Scan

Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be \>1 year; longest diameter \> 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter \>8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.

Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be \>1 year; longest diameter \> 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter \>8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years

For single nodules \>5 mm, clinical meaningful shrinkage of 30% or \> longest diameter (LD) considered treatment success after 1 year treatment; for \<5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all target \& non target lesions + no appearance new lesions; PR: CR for target lesions+incomplete/SD for non target lesions+no new lesions or PR (i.e., 30%\<sum LD target lesions) for target lesions + no PD for non target lesions + no appearance of new lesions; PD: PD (at least 20% \> sum LD of target lesions) for target lesions irrespective of response of non target lesions or PD for non target lesions irrespective of response for target lesions/or appearance new lesions irrespective of response of target/or non target lesions; SD: neither sufficient shrinkage for PR nor increase for PD.

Number of participants with response according to RECIST criteria. For single nodules \> 5 mm, clinical meaningful shrinkage of 30% or \> of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD \<5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.

Arm I: Budesonide

Arm II: Placebo

Age, Continuous

Italy

Three (3) participants in Arm I: Budesonide, and one (1) in Arm II: Placebo later refused follow up CT and were excluded from overall analysis.

Powel H. Brown, MD, PhD/Professor of Medicine and Cancer Prevention

Nonsolid

Partially Solid

Solid

Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.

Number CT- Detected Lung Nodules by Participant

4-5 mm

5-8 mm

>8 mm

Per person analysis. Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.

Size of CT- Detected Lung Nodules by Participant

CR/PR

Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the Computed Tomography (CT) scan.

Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months

Subsolid, CR/PR

Subsolid, SD

Subsolid, PD

Solid, CR/PR

Solid, SD

Solid, PD

Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the follow up Computed Tomography (CT) scan.

Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months

Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD	NCT02504801	Post Operative ... Lung Cancer COPD	Budesonide	40 Years - 80 Years	Xuanwu Hospital, Beijing
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi	NCT01946711	Rhinosinusitis Chronic Polypos...	Budesonide Budesonide	18 Years -	Pari Pharma GmbH
Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia	NCT00005880	Lung Cancer	budesonide	40 Years - 74 Years	National Cancer Institute (NCI)
Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.	NCT03687515	Chronic Rhinosi...	budesonide budesonide Prednisone	23 Years - 64 Years	Beijing Tongren Hospital
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer	NCT00321893	Lung Cancer	Budesonide Placebo	50 Years -	National Cancer Institute (NCI)
Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia	NCT00005880	Lung Cancer	budesonide	40 Years - 74 Years	National Cancer Institute (NCI)
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer	NCT00321893	Lung Cancer	Budesonide Placebo	50 Years -	National Cancer Institute (NCI)
Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD	NCT02504801	Post Operative ... Lung Cancer COPD	Budesonide	40 Years - 80 Years	Xuanwu Hospital, Beijing

Spots Global Cancer Trial Database for budesonide

Every month we try and update this database with for budesonide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for budesonide

Every month we try and update this database with for budesonide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for budesonide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.