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Proposal 1377

Title of the Proposed Research

The association between patient outcomes under two treatments (ABOUT) in cross-over trials

Lead Researcher

Marc Buyse, ScD

Affiliation

IDDI
30 avenue provinciale
1340 Louvain-la-Neuve
Belgium

Funding Source

Research funded by IDDI

Potential Conflicts of Interest

None

Data Sharing Agreement Date

6 April 2016

Lay Summary

In the so-called cross-over clinical trial, each patient eventually receives all treatments being compared, one at each period of time. For instance, in the simple randomized “two-treatment, two-period” cross-over clinical trial, each patient receives both a period of experimental treatment and a period of control, with the order of these two periods varying from patient to patient randomly. Therefore, researchers can measure the response of each patient to both the experimental treatment and to control. Cross-over clinical trials are usually analyzed with the aim of determining if the experimental treatment is better (or worse, sometimes) than control, and this is done by taking “an average difference” between the effects of the treatment and the control. Here, we propose to analyze responses to both experimental treatment and control in each individual patient. Our goal is to find out if the responses in individual patients are linked (if most patients tend to respond or not to respond to both treatment and control) or whether they are independent (if the response of most patients is a random event with a probability that depends on the treatment type). Depending on our findings, future medical studies may use our results in order to decide on the most appropriate assumptions for some types of statistical analyses.

Study Data Provided

Study GSK-FFU105924 : A Randomized, Double-blind, Placebo-controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis
Study GSK-FFU105927: A Randomized, Double-blind, Placebo-controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis
Study GSK-NSG110341: A randomised, double-blind, placebo-controlled, 4-period, incomplete block, crossover study to assess the dose-response curve of intranasal fluticasone propionate (25, 50, 100 and 200 g, once daily for 8 days) in the Vienna Challenge Chamber for the purpose of investigating the sensitivity of the model when evaluating glucocorticosteroids
Study GSK-IPR110723: An 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR)
Study GSK-SIG110762: A randomised, placebo-controlled, incomplete block, three-way cross-over study to evaluate the effect of treatment with repeat inhaled doses of GW870086X on the allergen-induced early and late asthmatic response in subjects with mild asthma
Study GSK-TRX109011: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) vs. Butalbital-containing Combination Medications for the Acute Treatment of Migraine when administered during the Moderate-Severe Migraine Pain, 1 of 2
Study GSK-NKI110334: A multi-centre, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of GW597599 and GR205171 on sleep continuity, PSG sleep recordings, subjective sleep assessment and daytime cognitive function in subjects with primary insomnia
Study GSK-FFA112202: A Multi-Centre, Randomized, Double Blind Cross-over study to assess the non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients with Asthma
Study GSK-RES104385: 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.
Study GSK-HZC110946: A three-way incomplete block crossover study to investigate the 24-hour pulmonary function of three dosage strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder vs. Placebo, in subjects with Chronic Obstructive Pulmonary Disease (COPD)
Study GSK-HZA113090: A randomised, double-blind, placebo-controlled, three-way crossover, repeat dose pilot study comparing the effect of inhaled fluticasone furoate/GW642444M combination and fluticasone furoate on the allergen-induced early asthmatic response in subjects with mild asthma
Study GSK-HZA113126: A randomised, double-blind, placebo-controlled, four-way crossover, repeat dose study comparing the effect of inhaled fluticasone furoate/GW642444M combination, GW642444M and fluticasone furoate on the allergen-induced asthmatic response in subjects with mild asthma
Study GSK-HZA113310: A multi-center, randomized, double-blind, placebo-controlled, five period cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of GW642444 administered via a novel dry powder inhaler (NDPI) in subjects ≥18 years of age with persistent asthma
Study GSK-LPA114255: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeterol 50mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects ≥ 12 Years of Age
Study GSK-SCO104962: A randomised, double-blind, double dummy, 3 way crossover study evaluating the effects of a combination of Seretide 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual agents (tiotropium bromide 18mcg alone and Seretide50/500mcg alone) in the treatment of subjects with COPD
Study GSK-FFR105693: A Randomized, Single-Blind, Cross-Over, Multicenter Study to Validate the Preference Module of the Experience with Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Administered to Adult Subjects with Seasonal Allergic Rhinitis during a Three-week Cross-over Study
Study GSK-AC4115321: A randomized, double blind, placebo controlled, incomplete block, crossover, dose ranging study to evaluate the dose response of GSK573719 administered once or twice daily over 7 days in patients with Chronic Obstructive Pulmonary Disease (COPD)
Study GSK-VLX103596: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Way Crossover Study to Investigate the Effect of VALTREX 1g Once Daily for 60 Days on Viral Shedding in HSV-2 Seropositive Subjects with No Previous History of Symptomatic Genital Herpes Infection.
Study LILLY-B4Z-MC-LYCK: A Randomized, Double-Blind, Crossover Comparison of Atomoxetine and Placebo in Child Outpatients With Attention-Deficit/Hyperactivity Disorder, Reading Disorder, or Comorbid Attention-Deficit/Hyperactivity Disorder and Reading Disorder
Study BI-1222.40: A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
Study BI-205.291: A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study GSK-LPA111834: A randomised, double-blind, placebo-controlled, 2-period cross-over study to evaluate the effect of treatment with GSK2190915 on the allergen-induced asthmatic response in subjects with mild asthma
Study GSK-LPA112025: A multi-centre, randomized, double-blind, five-way crossover study evaluating the dose response and duration of action of GSK2190915 compared to placebo in subjects with mild asthma who experience exercise induced bronchoconstriction.
Study GSK-VR1114974 : A randomised, double blind, placebo controlled, 2-way cross-over study in adults with non-allergic rhinitis to evaluate the effect of once daily administration of intranasal SB-705498 12mg for two weeks and the response to a chamber challenge of cold dry air
Study GSK-NKP106254: Randomised, double-blind, placebo controlled, cross-over study comparing the effects of both single dose and repeated dosing treatment for 14 days of vestipitant or vestipitant / paroxetine combination in an enriched population of subjects with tinnitus & hearing loss
Study TAKEDA-01-02-TL-375-017: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects With Chronic Insomnia
Study TAKEDA-TAK-375/CCT-001: A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation
Study GSK-RES114748: A randomized, double blind, placebo-controlled three-way crossover study in mild asthmatics to evaluate the effect of smoking status on the attenuation by inhaled corticosteroids of the allergen-induced asthmatic response.
Study GSK-LPA112356: A randomised, double-blind, placebo-controlled, 3-period cross-over study to evaluate the effect of two doses of GSK2190915 on the allergen-induced early asthmatic response in subjects with mild asthma
Study GSK-LPA114387: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Treatment, Three 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 300mg as Compared to Adding Montelukast 10mg or Placebo Tablets QD to Fluticasone Propionate/Salmeterol 250/50mcg Diskus BID
Study GSK-DB2114956: A 4-Week Randomized Cross-Over Study to Evaluate Daily Lung Function Following the Administration of Albuterol/Salbutamol and Ipratropium in Subjects with Chronic Obstructive Pulmonary Disease
Study GSK-TRX103635: A randomized, double-blind, multi-center, placebo-controlled, cross-over study to determine the consistency of response for Trexima* (sumatriptan 85mg/naproxen sodium 500mg) administered during the mild pain phase for the acute treatment of multiple migraine attacks (*Treximet)
Study GSK-HHI110159: A randomised, double-blind, placebo-controlled, 3-period crossover study to assess the efficacy and safety of single dose intranasal GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic rhinitis
Study GSK-HHI112864: A randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis
Study GSK-HH3110163: A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis
Study GSK-SIG112851: A randomised, double-blind, placebo-controlled, 2-way crossover study to determine the efficacy of repeat inhaled doses of GW870086X on FEV1 in mild to moderate asthmatics

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.