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dbGaP phs000422 NHLBI GO-ESP: Lung Cohorts Exome Sequencing Project (Asthma) - Eligibility

- 2022-10-12 - 5 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Deborah A. Meyers, PhD, Wake Forest School of Medicine, Winston-Salem, NC, USA MeSH: Asthma,Respiratory Function Tests https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000422 The NHLBI "Grand Opportunity" Exome Sequencing Project (GO-ESP), a signature project of the NHLBI Recovery Act investment, was designed to identify genetic variants in coding regions (exons) of the human genome (the "exome") that are associated with heart, lung and blood diseases. These and related diseases that are of high impact to public health and individuals from diverse racial and ethnic groups will be studied. These data may help researchers understand the causes of disease, contributing to better ways to prevent, diagnose, and treat diseases, as well as determine whether to tailor prevention and treatments to specific populations. This could lead to more effective treatments and reduce the likelihood of side effects. GO-ESP is comprised of five collaborative components: 3 cohort consortia - HeartGO, LungGO, and WHISP - and 2 sequencing centers - BroadGO and SeattleGO. The exome sequencing asthma project includes 200 African-Americans with asthma from the NHLBI multicenter Severe Asthma Research Program (SARP). SARP participants were recruited at the NHLBI SARP sites with an emphasis on recruiting severe asthmatics (Moore et al., Am J Respir Crit Care Med, 2010. PMID: 19892860). Asthma status was based on both a physician's diagnosis and either bronchodilator reversibility or hyper-responsiveness to methacholine as well as less than 5 pack years of smoking. All subjects were carefully characterized using the standardized SARP protocol which included spirometry (medication withheld), maximum bronchodilator reversibility, hyper-responsiveness to methacholine (not performed in subjects with low baseline FEV1), skin-tests to common allergens, questionnaires on health care utilization and medication use and sputum, lung imaging and bronchoscopy in a subset. In addition GWAS data are available (phs000355, Illumina platform).

pht003223.v1.p1

1 Item-grupp 5 Dataelement

pht003224.v1.p1

1 Item-grupp 3 Dataelement

pht003225.v1.p1

1 Item-grupp 15 Dataelement

pht003226.v1.p1

1 Item-grupp 4 Dataelement

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge

- 2021-09-27 - 1 Formulär, 8 Item-grupper, 41 Dataelement, 1 Språk
Item-grupper: Pulmonary function tests: Pre-Methacholine Challenge, Pulmonary function tests: Methacholine Challenge, Pulmonary function tests: Post-Methacholine Challenge, PC20 (Methacholine Challenge), Skin Prick Test, Pulmonary function tests: pre-asthma-allergen challenge, Pulmonary function tests: asthma-allergen Challenge, Pulmonary function tests: Post-asthma-allergen Challenge
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Screening Part 5 - Pulmonary function: Methacholine and Asthma-allergen challenge.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Screening Part 4 - ECG and Pulmonary function (exhaled nitric oxide and AMP Challenge)

- 2018-04-10 - 1 Formulär, 7 Item-grupper, 43 Dataelement, 1 Språk
Item-grupper: 12-Lead ECG, Exhaled nitric oxide, Pulmonary function tests / FEV 1, Pulmonary function tests: Pre-AMP Challenge, Pulmonary function tests: AMP Challenge, Pulmonary function tests: Post-AMP Challenge, PC20 (AMP Challenge)
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Screening Part 4 - ECG and Pulmonary function parts Exhaled nitric oxide and AMP Challenge.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Visit 1: Pulmonary Function Test

- 2018-12-06 - 1 Formulär, 1 Item-grupp, 3 Dataelement, 1 Språk
Item-grupp: Pre-Bronchodilator
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Lung function testing - Treatment Period 2, Day 29

- 2018-04-10 - 1 Formulär, 5 Item-grupper, 28 Dataelement, 1 Språk
Item-grupper: Exhaled nitric oxide, Pulmonary function tests / FEV 1, Pulmonary function tests: Pre-Methacholine Challenge, Pulmonary function tests: Methacholine Challenge, Pulmonary function tests: Post-Methacholine Challenge
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Lung function testing: Exhaled nitric oxide, pulmonary function tests, Methacholine Challenge. Time: Treatment Period 2, Day 29.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Lung function testing - Treatment Period 1, Day 29

- 2018-04-10 - 1 Formulär, 5 Item-grupper, 28 Dataelement, 1 Språk
Item-grupper: Exhaled nitric oxide, Pulmonary function tests / FEV 1, Pulmonary function tests: Pre-Methacholine Challenge, Pulmonary function tests: Methacholine Challenge, Pulmonary function tests: Post-Methacholine Challenge
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Lung function testing: Exhaled nitric oxide, pulmonary function tests, Methacholine Challenge. Time: Treatment Period 1, Day 29.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Pharmacodynamics - Treatment period 1, Day 29

- 2018-04-10 - 1 Formulär, 6 Item-grupper, 58 Dataelement, 1 Språk
Item-grupper: Baseline FEV1 Measurement - Sputum Induction post-challenge, Sputum induction post-challenge, Sputum post-challenge sample, Sputum hemacytometry post-challenge, Sputum induction post-challenge summary, Sputum slide results post-challenge
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Pharmacodynamics. Time: Treatment period 1, Day 29. Sputum Induction.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Pharmacodynamics - Treatment period 2, Day 29

- 2018-04-10 - 1 Formulär, 6 Item-grupper, 58 Dataelement, 1 Språk
Item-grupper: Baseline FEV1 Measurement - Sputum Induction post-challenge, Sputum induction post-challenge, Sputum post-challenge sample, Sputum hemacytometry post-challenge, Sputum induction post-challenge summary, Sputum slide results post-challenge
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Pharmacodynamics. Time: Treatment period 2, Day 29. Sputum Induction.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Follow-Up Part 1 - Physical Examination, Pulmonary Function Test

- 2018-04-10 - 1 Formulär, 5 Item-grupper, 48 Dataelement, 1 Språk
Item-grupper: Administrative data, Vital signs, Pedal Oedema, Physical examination, Pulmonary function tests / FEV 1
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Follow-Up Part 1: Physical Examination, Vital Signs and Pedal Oedema as well as Pulmonary Function Test.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Lung function testing - Treatment Period 1, Day 28

- 2018-04-10 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Exhaled nitric oxide, Pulmonary function tests / FEV 1
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Lung function testing: Exhaled nitric oxide, pulmonary function tests. Time: Treatment Period 1, Day 28.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Lung function testing - Treatment Period 2, Day 28

- 2018-04-10 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Exhaled nitric oxide, Pulmonary function tests / FEV 1
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Lung function testing: Exhaled nitric oxide, pulmonary function tests. Time: Treatment Period 2, Day 28.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Lung function testing - Treatment Period 1, Day 1

- 2018-04-10 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Exhaled nitric oxide, Pulmonary function tests / FEV 1
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Lung function testing: Exhaled nitric oxide, pulmonary function tests. Time: Treatment Period 1, Day 1.

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