A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
NCT ID: NCT03086460
Last Updated: 2021-08-16
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
67 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-08
Study Completion Date
2018-07-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To evaluate the dose-response of different doses of CHF 1531 pressurized metered dose inhaler (pMDI) containing formoterol fumarate, on lung function and other clinical outcomes and to identify the optimal dose(s) with regard to benefit/ risk ratio for further development in the target subject population.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
NCT02105012
Asthma
COMPLETED
PHASE2
Study in Patients With Asthma
NCT00215371
Asthma
COMPLETED
PHASE2
The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)
NCT00076076
Asthma
COMPLETED
PHASE3
Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
NCT07301736
Asthma
RECRUITING
PHASE2
A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma
NCT00862394
Asthma
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a phase II, randomized, double-blind, placebo and active controlled dose-ranging, 6 arm incomplete block cross-over study to identify the optimal dose of CHF 1531 pMDI (containing formoterol fumarate), with regard to lung function and other clinical efficacy and safety outcome measures.
After a 2 week run-in period under rescue albuterol 'as needed' and background inhaled corticosteroid (ICS), subjects qualifying for the study were required to complete 4 treatment intervals of 2 weeks each, separated by 2 week wash-out intervals.
During each treatment interval, the subject were randomly assigned to take one of 5 double-blind study treatments twice daily (BID) i.e. one of 4 doses of CHF 1531 pMDI or a matching placebo or the open-label active control treatment (Perforomist® Inhalation Solution \[IS\]) also BID. During the entire study, all subjects concomitantly received ICS treatment with QVAR® inhaler (beclomethasone dipropionate 40 or 80 µg /actuation) twice daily at a dose that matches their pre-enrollment ICS and an albuterol inhaler to use as asthma rescue medication on 'as needed' basis. The subjects visited the study center every 2 weeks to undergo study procedures, and received a safety follow-up phone call one week after their last visit. In total, the study lasted 18 weeks and required 10 visits to the study center.
During the study, daily asthma symptoms, peak expiratory flow, rescue and background medication use, and compliance with the study medication were recorded in a subject diary. Treatment-Emergent Adverse Events (TEAEs) were assessed and recorded throughout the study. A full physical exam, routine hematology, blood chemistry, spirometry, vital signs measurement, 12-lead ECG, and pregnancy testing were performed before enrollment and at the end of the study. Furthermore, on Day 1 and 14 of each treatment interval, serial spirometry, 12-lead ECGs, blood pressure measurements (BP), serum potassium, and serum glucose were measured at the study center for up to 12 hours post-dose.
After a 2 week run-in period under rescue albuterol 'as needed' and background inhaled corticosteroid (ICS), subjects qualifying for the study were required to complete 4 treatment intervals of 2 weeks each, separated by 2 week wash-out intervals.
During each treatment interval, the subject were randomly assigned to take one of 5 double-blind study treatments twice daily (BID) i.e. one of 4 doses of CHF 1531 pMDI or a matching placebo or the open-label active control treatment (Perforomist® Inhalation Solution \[IS\]) also BID. During the entire study, all subjects concomitantly received ICS treatment with QVAR® inhaler (beclomethasone dipropionate 40 or 80 µg /actuation) twice daily at a dose that matches their pre-enrollment ICS and an albuterol inhaler to use as asthma rescue medication on 'as needed' basis. The subjects visited the study center every 2 weeks to undergo study procedures, and received a safety follow-up phone call one week after their last visit. In total, the study lasted 18 weeks and required 10 visits to the study center.
During the study, daily asthma symptoms, peak expiratory flow, rescue and background medication use, and compliance with the study medication were recorded in a subject diary. Treatment-Emergent Adverse Events (TEAEs) were assessed and recorded throughout the study. A full physical exam, routine hematology, blood chemistry, spirometry, vital signs measurement, 12-lead ECG, and pregnancy testing were performed before enrollment and at the end of the study. Furthermore, on Day 1 and 14 of each treatment interval, serial spirometry, 12-lead ECGs, blood pressure measurements (BP), serum potassium, and serum glucose were measured at the study center for up to 12 hours post-dose.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Asthma
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
OTHER
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment A
Treatment A, CHF 1531 pMDI:
CHF 1531 pMDI 6 μg total daily dose (TDD):
1 inhalation of CHF 1531 pMDI 3 μg/actuation plus 1 inhalation of CHF 1531 matched Placebo BID.
Group Type
EXPERIMENTAL
CHF 1531 pMDI
Intervention Type
DRUG
Dose Response: Test one of five different doses of CHF 1531
Treatment B
Treatment B, CHF 1531 pMDI:
CHF 1531 pMDI 12 μg TDD:
1 inhalation of CHF 1531 pMDI 6 μg/actuation plus 1 inhalation of CHF 1531 matched Placebo BID.
Group Type
EXPERIMENTAL
CHF 1531 pMDI
Intervention Type
DRUG
Dose Response: Test one of five different doses of CHF 1531
Treatment C
Treatment C, CHF 1531 pMDI:
CHF 1531 pMDI 24 μg TDD: 2 inhalations of CHF 1531 pMDI 6 μg/actuation BID.
Group Type
EXPERIMENTAL
CHF 1531 pMDI
Intervention Type
DRUG
Dose Response: Test one of five different doses of CHF 1531
Treatment D
Treatment D, CHF 1531 pMDI
CHF 1531 pMDI 48 μg TDD: 2 inhalations of CHF 1531 pMDI 12 μg/actuation BID.
Group Type
EXPERIMENTAL
CHF 1531 pMDI
Intervention Type
DRUG
Dose Response: Test one of five different doses of CHF 1531
Treatment E
Treatment E, Matched placebo
Placebo: 2 inhalations of CHF 1531 pMDI matched Placebo BID.
Group Type
EXPERIMENTAL
Placebo pMDI
Intervention Type
DRUG
Matched Placebo
Treatment F
Treatment F, Formoterol fumarate inhalation solution (IS)
Perforomist® IS (active comparator, open-label) 40 μg TDD: 1 inhalation, 20 μg/ 2 mL vial, 1 vial BID.
Group Type
ACTIVE_COMPARATOR
Formoterol Inhalation Solution
Intervention Type
DRUG
Active Control
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHF 1531 pMDI
Dose Response: Test one of five different doses of CHF 1531
Intervention Type
DRUG
Formoterol Inhalation Solution
Active Control
Intervention Type
DRUG
Placebo pMDI
Matched Placebo
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
PERFOROMIST® 20 μg/ 2 mL vial, 1 vial BID
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female subjects aged ≥18 and ≤75 years who have signed an Informed Consent Form prior to initiation of any study-related procedure.
* A diagnosis of asthma as defined in the Global Initiative for Asthma (GINA) Report, 2016, documented for at least 1 year prior to screening.
* Poorly controlled or uncontrolled asthma evidenced by a score ≥1.5 on the Asthma Control Questionnaire 7 © (ACQ-7)
* A pre-bronchodilator Forced Expiratory Volume in the 1st Second ( FEV1) ≥60% and \<85% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits
* Subjects with a positive response to a reversibility test at screening, defined as change in FEV1 (ΔFEV1) ≥12% and ≥200 mL over baseline within 30 minutes after inhaling 4 puffs of albuterol hydrofluoroalkane(HFA) 90 µg/actuation.
* Use of ICS (low/medium dose according to GINA Report, 2016) with or without a long-acting bronchodilator for 3 months (at a stable dose in the last 4 weeks) before screening visit.
* A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhaler.
* A diagnosis of asthma as defined in the Global Initiative for Asthma (GINA) Report, 2016, documented for at least 1 year prior to screening.
* Poorly controlled or uncontrolled asthma evidenced by a score ≥1.5 on the Asthma Control Questionnaire 7 © (ACQ-7)
* A pre-bronchodilator Forced Expiratory Volume in the 1st Second ( FEV1) ≥60% and \<85% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits
* Subjects with a positive response to a reversibility test at screening, defined as change in FEV1 (ΔFEV1) ≥12% and ≥200 mL over baseline within 30 minutes after inhaling 4 puffs of albuterol hydrofluoroalkane(HFA) 90 µg/actuation.
* Use of ICS (low/medium dose according to GINA Report, 2016) with or without a long-acting bronchodilator for 3 months (at a stable dose in the last 4 weeks) before screening visit.
* A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhaler.
Exclusion Criteria
* Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS they are willing to use a highly effective birth control methods
* Subjects who suffer from Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Strategy for Prevention, Diagnosis and Management of COPD (GOLD) Report, 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as described in the GINA Report, 2016.
* Inability to carry out pulmonary function testing, to comply with study procedures or with study drug intake.
* Current smokers or ex-smokers (tobacco, vapor cigarettes, marijuana) with a smoking history of \>10 pack-years or having stopped smoking one year or less prior to screening visit.
* History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.
* An asthma exacerbation requiring oral/intravenous corticosteroids ≤ 30 days, intramuscular depot corticosteroid ≤3 months or hospitalization within 6 months prior to screening.
* Subjects with unresolved bacterial or viral respiratory tract, sinus, or middle ear infection affecting asthma status within 2 weeks prior to screening.
* Subjects who received a vaccination within 2 weeks prior to screening or during the run-in.
* Subjects with oral candidiasis at screening and at randomization.
* Subjects with any clinically significant, uncontrolled condition.
* Subjects with serum potassium levels \<3.5 milliequivalents per litre (mEq/L) or (3.5 mmol/L) at screening.
* Subjects who have clinically significant cardiovascular condition.
* Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the patient according to Investigator's judgment.
* Subjects whose 12-lead ECG shows Fridericia's corrected QT interval (QTcF) \>450 ms for males or QTcF \>470 ms for females at screening or randomization visits.
* Subjects with known intolerance/hypersensitivity or contra-indication to treatment with inhaled β2-adrenergic receptor agonists, corticosteroids or propellant gases/excipients.
* Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti- Immunoglobulin E (IgE), anti-Interleukin 5 (IL5) or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
* Use of potent cytochrome P450 3A4 inhibitors and inducers within 4 weeks prior to screening.
* History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening.
* Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
* Subjects who are mentally or legally incapacitated or subjects accommodated in an establishment as a result of an official or judicial order.
* Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.
* Subjects who suffer from Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Strategy for Prevention, Diagnosis and Management of COPD (GOLD) Report, 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as described in the GINA Report, 2016.
* Inability to carry out pulmonary function testing, to comply with study procedures or with study drug intake.
* Current smokers or ex-smokers (tobacco, vapor cigarettes, marijuana) with a smoking history of \>10 pack-years or having stopped smoking one year or less prior to screening visit.
* History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.
* An asthma exacerbation requiring oral/intravenous corticosteroids ≤ 30 days, intramuscular depot corticosteroid ≤3 months or hospitalization within 6 months prior to screening.
* Subjects with unresolved bacterial or viral respiratory tract, sinus, or middle ear infection affecting asthma status within 2 weeks prior to screening.
* Subjects who received a vaccination within 2 weeks prior to screening or during the run-in.
* Subjects with oral candidiasis at screening and at randomization.
* Subjects with any clinically significant, uncontrolled condition.
* Subjects with serum potassium levels \<3.5 milliequivalents per litre (mEq/L) or (3.5 mmol/L) at screening.
* Subjects who have clinically significant cardiovascular condition.
* Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the patient according to Investigator's judgment.
* Subjects whose 12-lead ECG shows Fridericia's corrected QT interval (QTcF) \>450 ms for males or QTcF \>470 ms for females at screening or randomization visits.
* Subjects with known intolerance/hypersensitivity or contra-indication to treatment with inhaled β2-adrenergic receptor agonists, corticosteroids or propellant gases/excipients.
* Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti- Immunoglobulin E (IgE), anti-Interleukin 5 (IL5) or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
* Use of potent cytochrome P450 3A4 inhibitors and inducers within 4 weeks prior to screening.
* History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening.
* Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
* Subjects who are mentally or legally incapacitated or subjects accommodated in an establishment as a result of an official or judicial order.
* Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chiesi Farmaceutici S.p.A.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard Sterling
Role: PRINCIPAL_INVESTIGATOR
Sterling ENT, PA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chiesi Investigational Site
Tucson, Arizona, United States
Site Status
Chiesi Investigational Site
Los Angeles, California, United States
Site Status
Chiesi Investigational Site
Lutherville, Maryland, United States
Site Status
Chiesi Investigational Site
St Louis, Missouri, United States
Site Status
Chiesi Investigational Site
Raleigh, North Carolina, United States
Site Status
Chiesi Investigational Site
Greenville, South Carolina, United States
Site Status
Chiesi Investigational Site
Orangeburg, South Carolina, United States
Site Status
Chiesi Investigational Site
Spartanburg, South Carolina, United States
Site Status
Chiesi Investigational Site
Knoxville, Tennessee, United States
Site Status
Chiesi Investigational Site
Richland, Washington, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.
Reference Type
BACKGROUND
Tilert T, Dillon C, Paulose-Ram R, Hnizdo E, Doney B. Estimating the U.S. prevalence of chronic obstructive pulmonary disease using pre- and post-bronchodilator spirometry: the National Health and Nutrition Examination Survey (NHANES) 2007-2010. Respir Res. 2013 Oct 9;14(1):103. doi: 10.1186/1465-9921-14-103.
Reference Type
BACKGROUND
Mannino DM. COPD: epidemiology, prevalence, morbidity and mortality, and disease heterogeneity. Chest. 2002 May;121(5 Suppl):121S-126S. doi: 10.1378/chest.121.5_suppl.121s.
Reference Type
BACKGROUND
Tonnesen P. Smoking cessation and COPD. Eur Respir Rev. 2013 Mar 1;22(127):37-43. doi: 10.1183/09059180.00007212.
Reference Type
BACKGROUND
van Eerd EA, van der Meer RM, van Schayck OC, Kotz D. Smoking cessation for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Aug 20;2016(8):CD010744. doi: 10.1002/14651858.CD010744.pub2.
Reference Type
BACKGROUND
Kew KM, Mavergames C, Walters JA. Long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 15;2013(10):CD010177. doi: 10.1002/14651858.CD010177.pub2.
Reference Type
BACKGROUND
McGarvey L, Niewoehner D, Magder S, Sachs P, Tetzlaff K, Hamilton A, Korducki L, Bothner U, Vogelmeier C, Koch A, Ferguson GT. One-Year Safety of Olodaterol Once Daily via Respimat(R) in Patients with GOLD 2-4 Chronic Obstructive Pulmonary Disease: Results of a Pre-Specified Pooled Analysis. COPD. 2015;12(5):484-93. doi: 10.3109/15412555.2014.991864. Epub 2015 Feb 18.
Reference Type
BACKGROUND
Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.
Reference Type
BACKGROUND
Keating GM. Tiotropium bromide inhalation powder: a review of its use in the management of chronic obstructive pulmonary disease. Drugs. 2012 Jan 22;72(2):273-300. doi: 10.2165/11208620-000000000-00000.
Reference Type
BACKGROUND
Casaburi R, Kukafka D, Cooper CB, Witek TJ Jr, Kesten S. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest. 2005 Mar;127(3):809-17. doi: 10.1378/chest.127.3.809.
Reference Type
BACKGROUND
Kesten S, Casaburi R, Kukafka D, Cooper CB. Improvement in self-reported exercise participation with the combination of tiotropium and rehabilitative exercise training in COPD patients. Int J Chron Obstruct Pulmon Dis. 2008;3(1):127-36. doi: 10.2147/copd.s2389.
Reference Type
BACKGROUND
Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009285. doi: 10.1002/14651858.CD009285.pub2.
Reference Type
BACKGROUND
Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.
Reference Type
BACKGROUND
Yang IA, Clarke MS, Sim EH, Fong KM. Inhaled corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD002991. doi: 10.1002/14651858.CD002991.pub3.
Reference Type
BACKGROUND
Kew KM, Seniukovich A. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014 Mar 10;2014(3):CD010115. doi: 10.1002/14651858.CD010115.pub2.
Reference Type
BACKGROUND
Yawn BP, Li Y, Tian H, Zhang J, Arcona S, Kahler KH. Inhaled corticosteroid use in patients with chronic obstructive pulmonary disease and the risk of pneumonia: a retrospective claims data analysis. Int J Chron Obstruct Pulmon Dis. 2013;8:295-304. doi: 10.2147/COPD.S42366. Epub 2013 Jun 27.
Reference Type
BACKGROUND
Rachelefsky GS, Liao Y, Faruqi R. Impact of inhaled corticosteroid-induced oropharyngeal adverse events: results from a meta-analysis. Ann Allergy Asthma Immunol. 2007 Mar;98(3):225-38. doi: 10.1016/S1081-1206(10)60711-9.
Reference Type
BACKGROUND
Roland NJ, Bhalla RK, Earis J. The local side effects of inhaled corticosteroids: current understanding and review of the literature. Chest. 2004 Jul;126(1):213-9. doi: 10.1378/chest.126.1.213.
Reference Type
BACKGROUND
Tashkin DP, Murray HE, Skeans M, Murray RP. Skin manifestations of inhaled corticosteroids in COPD patients: results from Lung Health Study II. Chest. 2004 Oct;126(4):1123-33. doi: 10.1016/S0012-3692(15)31287-3.
Reference Type
BACKGROUND
Crim C, Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Willits LR, Yates JC, Vestbo J. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J. 2009 Sep;34(3):641-7. doi: 10.1183/09031936.00193908. Epub 2009 May 14.
Reference Type
BACKGROUND
Crim C, Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Lettis S, Calverley PM. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD. Ann Am Thorac Soc. 2015 Jan;12(1):27-34. doi: 10.1513/AnnalsATS.201409-413OC.
Reference Type
BACKGROUND
Pavord ID, Lettis S, Anzueto A, Barnes N. Blood eosinophil count and pneumonia risk in patients with chronic obstructive pulmonary disease: a patient-level meta-analysis. Lancet Respir Med. 2016 Sep;4(9):731-741. doi: 10.1016/S2213-2600(16)30148-5. Epub 2016 Jul 23.
Reference Type
BACKGROUND
Johnell O, Pauwels R, Lofdahl CG, Laitinen LA, Postma DS, Pride NB, Ohlsson SV. Bone mineral density in patients with chronic obstructive pulmonary disease treated with budesonide Turbuhaler. Eur Respir J. 2002 Jun;19(6):1058-63. doi: 10.1183/09031936.02.00276602.
Reference Type
BACKGROUND
Ferguson GT, Calverley PMA, Anderson JA, Jenkins CR, Jones PW, Willits LR, Yates JC, Vestbo J, Celli B. Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study. Chest. 2009 Dec;136(6):1456-1465. doi: 10.1378/chest.08-3016. Epub 2009 Jul 6.
Reference Type
BACKGROUND
Loke YK, Cavallazzi R, Singh S. Risk of fractures with inhaled corticosteroids in COPD: systematic review and meta-analysis of randomised controlled trials and observational studies. Thorax. 2011 Aug;66(8):699-708. doi: 10.1136/thx.2011.160028. Epub 2011 May 20.
Reference Type
BACKGROUND
Suissa S, Kezouh A, Ernst P. Inhaled corticosteroids and the risks of diabetes onset and progression. Am J Med. 2010 Nov;123(11):1001-6. doi: 10.1016/j.amjmed.2010.06.019. Epub 2010 Oct 1.
Reference Type
BACKGROUND
Wang JJ, Rochtchina E, Tan AG, Cumming RG, Leeder SR, Mitchell P. Use of inhaled and oral corticosteroids and the long-term risk of cataract. Ophthalmology. 2009 Apr;116(4):652-7. doi: 10.1016/j.ophtha.2008.12.001. Epub 2009 Feb 25.
Reference Type
BACKGROUND
Miller DP, Watkins SE, Sampson T, Davis KJ. Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database. Int J Chron Obstruct Pulmon Dis. 2011;6:467-76. doi: 10.2147/COPD.S14247. Epub 2011 Sep 16.
Reference Type
BACKGROUND
Andrejak C, Nielsen R, Thomsen VO, Duhaut P, Sorensen HT, Thomsen RW. Chronic respiratory disease, inhaled corticosteroids and risk of non-tuberculous mycobacteriosis. Thorax. 2013 Mar;68(3):256-62. doi: 10.1136/thoraxjnl-2012-201772. Epub 2012 Jul 10.
Reference Type
BACKGROUND
Aaron SD, Vandemheen KL, Fergusson D, Maltais F, Bourbeau J, Goldstein R, Balter M, O'Donnell D, McIvor A, Sharma S, Bishop G, Anthony J, Cowie R, Field S, Hirsch A, Hernandez P, Rivington R, Road J, Hoffstein V, Hodder R, Marciniuk D, McCormack D, Fox G, Cox G, Prins HB, Ford G, Bleskie D, Doucette S, Mayers I, Chapman K, Zamel N, FitzGerald M; Canadian Thoracic Society/Canadian Respiratory Clinical Research Consortium. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2007 Apr 17;146(8):545-55. doi: 10.7326/0003-4819-146-8-200704170-00152. Epub 2007 Feb 19.
Reference Type
BACKGROUND
Singh D, Brooks J, Hagan G, Cahn A, O'Connor BJ. Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD. Thorax. 2008 Jul;63(7):592-8. doi: 10.1136/thx.2007.087213. Epub 2008 Feb 1.
Reference Type
BACKGROUND
Hanania NA, Crater GD, Morris AN, Emmett AH, O'Dell DM, Niewoehner DE. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med. 2012 Jan;106(1):91-101. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29.
Reference Type
BACKGROUND
Frith PA, Thompson PJ, Ratnavadivel R, Chang CL, Bremner P, Day P, Frenzel C, Kurstjens N; Glisten Study Group. Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial. Thorax. 2015 Jun;70(6):519-27. doi: 10.1136/thoraxjnl-2014-206670. Epub 2015 Apr 3.
Reference Type
BACKGROUND
Siler TM, Kerwin E, Singletary K, Brooks J, Church A. Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies. COPD. 2016;13(1):1-10. doi: 10.3109/15412555.2015.1034256. Epub 2015 Oct 9.
Reference Type
BACKGROUND
Singh D, Papi A, Corradi M, Pavlisova I, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Vestbo J. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting beta2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016 Sep 3;388(10048):963-73. doi: 10.1016/S0140-6736(16)31354-X. Epub 2016 Sep 1.
Reference Type
BACKGROUND
Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006 Jan;129(1):15-26. doi: 10.1378/chest.129.1.15.
Reference Type
BACKGROUND
Wijesinghe M, Weatherall M, Perrin K, Harwood M, Beasley R. Risk of mortality associated with formoterol: a systematic review and meta-analysis. Eur Respir J. 2009 Oct;34(4):803-11. doi: 10.1183/09031936.00159708.
Reference Type
BACKGROUND
Chowdhury BA, Dal Pan G. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med. 2010 Apr 1;362(13):1169-71. doi: 10.1056/NEJMp1002074. Epub 2010 Feb 24. No abstract available.
Reference Type
BACKGROUND
Drazen JM, O'Byrne PM. Risks of long-acting beta-agonists in achieving asthma control. N Engl J Med. 2009 Apr 16;360(16):1671-2. doi: 10.1056/NEJMe0902057. No abstract available.
Reference Type
BACKGROUND
Chowdhury BA, Seymour SM, Levenson MS. Assessing the safety of adding LABAs to inhaled corticosteroids for treating asthma. N Engl J Med. 2011 Jun 30;364(26):2473-5. doi: 10.1056/NEJMp1104375. No abstract available.
Reference Type
BACKGROUND
Stempel DA, Raphiou IH, Kral KM, Yeakey AM, Emmett AH, Prazma CM, Buaron KS, Pascoe SJ; AUSTRI Investigators. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. N Engl J Med. 2016 May 12;374(19):1822-30. doi: 10.1056/NEJMoa1511049. Epub 2016 Mar 6.
Reference Type
BACKGROUND
Stempel DA, Szefler SJ, Pedersen S, Zeiger RS, Yeakey AM, Lee LA, Liu AH, Mitchell H, Kral KM, Raphiou IH, Prillaman BA, Buaron KS, Yun Kirby S, Pascoe SJ; VESTRI Investigators. Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. N Engl J Med. 2016 Sep 1;375(9):840-9. doi: 10.1056/NEJMoa1606356.
Reference Type
BACKGROUND
Novartis Pharma. FORADIL®AEROLIZER® US Prescribing Information. Whitehouse Station, New Jersey; 2012 Sep.
Reference Type
BACKGROUND
Chiesi Farmaceutici S.p.A. A randomized, double blind, double dummy, cumulative dose, safety cross-over trial comparing 4 increasing doses of Formoterol-HFA (pMDI) versus 4 increasing doses of formoterol-DPI (Aerolizer®) and placebo (pMDI or Aerolizer ®) in asthmatic patients. RA/PR/3301/002/01.
Reference Type
BACKGROUND
Chiesi Farmaceutici S.p.A. A randomized, double blind, double dummy, single dose, crossover trial comparing the efficacy and safety of a single dose administered via 1 puff of 6 μg or 2 puffs of 6 μg of formoterol-HFA (pMDI) versus a single dose of 12 μg of formoterol- DPI (Foradil®Aerolizer®) and of placebo (pMDI or Aerolizer®) in moderate to severe asthmatic patients. RA/PR/3301/009/03.
Reference Type
BACKGROUND
Bensch G, Lapidus RJ, Levine BE, Lumry W, Yegen U, Kiselev P, Della Cioppa G. A randomized, 12-week, double-blind, placebo-controlled study comparing formoterol dry powder inhaler with albuterol metered-dose inhaler. Ann Allergy Asthma Immunol. 2001 Jan;86(1):19-27. doi: 10.1016/s1081-1206(10)62351-4.
Reference Type
BACKGROUND
Pleskow W, LaForce CF, Yegen U, Matos D, Della Cioppa G. Formoterol delivered via the dry powder Aerolizer inhaler versus albuterol MDI and placebo in mild-to-moderate asthma: a randomized, double-blind, double-dummy trial. J Asthma. 2003;40(5):505-14. doi: 10.1081/jas-120018780.
Reference Type
BACKGROUND
Dahl R, Greefhorst LA, Nowak D, Nonikov V, Byrne AM, Thomson MH, Till D, Della Cioppa G; Formoterol in Chronic Obstructive Pulmonary Disease I Study Group. Inhaled formoterol dry powder versus ipratropium bromide in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):778-84. doi: 10.1164/ajrccm.164.5.2007006.
Reference Type
BACKGROUND
Rossi A, Kristufek P, Levine BE, Thomson MH, Till D, Kottakis J, Della Cioppa G; Formoterol in Chronic Obstructive Pulmonary Disease (FICOPD) II Study Group. Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest. 2002 Apr;121(4):1058-69. doi: 10.1378/chest.121.4.1058.
Reference Type
BACKGROUND
Mylan Specialty L.P. PERFOROMIST® US Prescribing Information. Morgantown, West Virginia; 2013 Mar.
Reference Type
BACKGROUND
Gross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, Denis-Mize K; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008 Feb;102(2):189-97. doi: 10.1016/j.rmed.2007.10.007.
Reference Type
BACKGROUND
Chiesi Farmaceutici S.p.A. CHF 1535 HFA : BDP + formoterol 100/6 μg pressurized inhalation solution : Common Technical Document. Module 2.5: 8.
Reference Type
BACKGROUND
Bousquet J, Guenole E, Duvauchelle T, Vicaut E, Lefrancois G. A randomized, double-blind, double-dummy, single-dose, crossover trial evaluating the efficacy and safety profiles of two dose levels (12 and 24 microg) of formoterol-HFA (pMDI) vs. those of a dose level (24 microg) of formoterol-DPI (Foradil/Aerolizer) and of placebo (pMDI or Aerolizer) in moderate to severe asthmatic patients. Respiration. 2005;72 Suppl 1:13-9. doi: 10.1159/000083688.
Reference Type
BACKGROUND
Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. No abstract available.
Reference Type
BACKGROUND
Houghton CM, Langley SJ, Singh SD, Holden J, Monici Preti AP, Acerbi D, Poli G, Woodcock A. Comparison of bronchoprotective and bronchodilator effects of a single dose of formoterol delivered by hydrofluoroalkane and chlorofluorocarbon aerosols and dry powder in a double blind, placebo-controlled, crossover study. Br J Clin Pharmacol. 2004 Oct;58(4):359-66. doi: 10.1111/j.1365-2125.2004.02172.x.
Reference Type
BACKGROUND
Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2006 Apr;100(4):616-21. doi: 10.1016/j.rmed.2005.08.012. Epub 2005 Oct 13.
Reference Type
BACKGROUND
Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
Reference Type
BACKGROUND
Arievich H, Overend T, Renard D, Gibbs M, Alagappan V, Looby M, Banerji D. A novel model-based approach for dose determination of glycopyrronium bromide in COPD. BMC Pulm Med. 2012 Dec 8;12:74. doi: 10.1186/1471-2466-12-74.
Reference Type
BACKGROUND
Center for Drug Evaluation and Research Medical Review. Clinical Team Leader Memorandum: Formoterol fumarate inhalation solution 20mcg/2mL; NDA # 22-007: 2007 Mar 15.
Reference Type
BACKGROUND
Gross NJ, Kerwin E, Levine B, Kim KT, Denis-Mize K, Hamzavi M, Carpenter M, Rinehart M. Nebulized formoterol fumarate: Dose selection and pharmacokinetics. Pulm Pharmacol Ther. 2008 Oct;21(5):818-23. doi: 10.1016/j.pupt.2008.07.002. Epub 2008 Jul 8.
Reference Type
BACKGROUND
Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
Reference Type
BACKGROUND
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Reference Type
BACKGROUND
Hankinson JL, Kawut SM, Shahar E, Smith LJ, Stukovsky KH, Barr RG. Performance of American Thoracic Society-recommended spirometry reference values in a multiethnic sample of adults: the multi-ethnic study of atherosclerosis (MESA) lung study. Chest. 2010 Jan;137(1):138-45. doi: 10.1378/chest.09-0919. Epub 2009 Sep 9.
Reference Type
BACKGROUND
Hankinson JL, Bang KM. Acceptability and reproducibility criteria of the American Thoracic Society as observed in a sample of the general population. Am Rev Respir Dis. 1991 Mar;143(3):516-21. doi: 10.1164/ajrccm/143.3.516.
Reference Type
BACKGROUND
Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.
Reference Type
BACKGROUND
Virchow JC, Backer V, de Blay F, Kuna P, Ljorring C, Prieto JL, Villesen HH. Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement. Respir Med. 2015 May;109(5):547-56. doi: 10.1016/j.rmed.2015.01.012. Epub 2015 Feb 3.
Reference Type
BACKGROUND
Edwards D, Berry JJ. The efficiency of simulation-based multiple comparisons. Biometrics. 1987 Dec;43(4):913-28.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
http://goldcopd.org/
Global Initiative for Chronic Obstructive Lung Disease, Inc. Global strategy for the diagnosis, management, and prevention of Chronic Obstructive Pulmonary Disease: 2017
http://www.ginasthma.org
Global Initiative for Asthma. Global strategy for asthma management and prevention (2016 update). 2016.
https://www.cdc.gov/asthma/most_recent_data.htm
Centers for Disease Control and Prevention: Asthma
https://www.chiesi.com/en/air/
Chiesi Farmaceutici S.p.A Respiratory
https://www.chiesi.com/en/chiesi-farmaceutici-is-the-first-company-to-submit-a-marketing-authorisation-application-to-the-european-medicine-agency-for-a-triple-combination-for-the-treatment-of-copd-
Chiesi Farmaceutici S.p.A - Press Release: Chiesi Farmaceutifici is the first company to submit a marketing authorisation application to the European Medicine Agency for a triple combination for the treatment of COPD
http://www.rtmagazine.com/2015/10/asthma-copd-foradil-aerolizer-to-be-discontinued/
RT Magazine: Asthma-COPD Therapy Foradil Aerolizer to be Discontinued
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCD-05993AA3-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study in Patients With Asthma
NCT00215410
COMPLETED
PHASE2
Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma
NCT01641081
COMPLETED
PHASE2
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
NCT00393991
COMPLETED
PHASE3
Study in Patients With Asthma
NCT00215397
COMPLETED
PHASE2
A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics
NCT01689571
COMPLETED
PHASE2
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
NCT00130351
COMPLETED
PHASE3
A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma
NCT01591044
COMPLETED
PHASE2
A 12-Week Study in Adult Subjects With Asthma
NCT01516086
COMPLETED
PHASE2
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
NCT06433921
RECRUITING
PHASE1
Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children
NCT01584492
COMPLETED
PHASE2
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
NCT00394199
COMPLETED
PHASE3
Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
NCT01159912
COMPLETED
PHASE3
Study in Patients With Asthma
NCT00215358
COMPLETED
PHASE2
A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma
NCT06702462
COMPLETED
PHASE1
New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma
NCT00393952
COMPLETED
PHASE3
An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects
NCT03084718
COMPLETED
PHASE2
Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol
NCT01711086
UNKNOWN
PHASE1/PHASE2
A Dose-ranging Study of Fluticasone Furoate (FF)
NCT01563029
COMPLETED
PHASE2
Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate
NCT00400855
COMPLETED
PHASE2
A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
NCT00441441
COMPLETED
PHASE3
Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS).
NCT06264674
COMPLETED
PHASE3
GSK2190915 Moderate to Severe Asthma Study
NCT00850642
TERMINATED
PHASE2
A Study to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152A (Test) or HFA-134A (Reference) in Healthy Participants Aged 18 to 55 Inclusive
NCT06433908
COMPLETED
PHASE1
New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma
NCT00394121
COMPLETED
PHASE3