Chronic Obstructive Pulmonary DisorderPhase 3NCT02727660
A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)
A Phase 3 study testing BFF MDI (PT009) 320/9.6 μg, BFF MDI (PT009) 160/9.6 μg and FF MDI (PT005) 9.6 μg in people with Chronic Obstructive Pulmonary Disorder, run by Pearl Therapeutics, Inc. at 282 sites in 19 countries.
Trial summary
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disorder
- What is being tested?
- BFF MDI (PT009) 320/9.6 μg, BFF MDI (PT009) 160/9.6 μg and FF MDI (PT005) 9.6 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,876 participants
- Where
- 282 sitesin 19 countries
- Study dates
- 29 Apr 2016to 4 Apr 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give their signed written informed consent to participate
- At least 40 years of age and no older than 80 years of age
- COPD patients who are symptomatic
- Must be receiving one or more inhaled bronchodilators as maintenance therapy
- Must have a documented history of COPD exacerbations
Who cannot join
- Current diagnosis of asthma
- COPD due to α1-Antitrypsin Deficiency
- Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
- Long-term-oxygen therapy (≥ 15 hours a day).
Trial locations and contacts
282 sites in 19 countries.
282 sites in 19 countries
United States121 sites
Research Site
Amarillo, Texas, 79106
Research Site
Anderson, South Carolina, 29621
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Atlanta, Georgia, 30345
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Aurora, Illinois, 60506
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Austin, Texas, 78758
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Baytown, Texas, 77521
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Biddeford, Maine, 04005
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Boulder, Colorado, 80301
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Boynton Beach, Florida, 33472
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Brooklyn, New York, 11215
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Brownsburg, Indiana, 46112
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Canton, Ohio, 44718
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Chesterfield, Missouri, 63017
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Chicago, Illinois, 60607
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Chiefland, Florida, 32626
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Cincinnati, Ohio, 45242
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Clearwater, Florida, 33765
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Columbus, Ohio, 43207
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Columbus, Ohio, 43213
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Costa Mesa, California, 92627
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Cumberland, Rhode Island, 02864
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Dacula, Georgia, 30019
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Dallas, Texas, 75234
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Dayton, Ohio, 45417
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Daytona Beach, Florida, 32117
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Decatur, Georgia, 30033
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Denver, Colorado, 80246
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Dothan, Alabama, 36305
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East Providence, Rhode Island, 02914
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Edmond, Oklahoma, 73034
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Evansville, Indiana, 47714
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Everett, Washington, 98208
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Flagstaff, Arizona, 86001
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Franklin, Tennessee, 37067
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Gaffney, South Carolina, 29340
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Gaffney, South Carolina, 29341
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Gastonia, North Carolina, 28054
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Gold River, California, 95670
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Hazard, Kentucky, 41701
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Hialeah, Florida, 33012
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Hickory, North Carolina, 28601
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Hickory, North Carolina, 28602
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Houston, Texas, 77030
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Huntsville, Alabama, 35801
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Iowa City, Iowa, 52242
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Johnstown, Pennsylvania, 15905
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Kansas City, Missouri, 64128
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Kerrville, Texas, 78028
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Kissimmee, Florida, 34741
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Knoxville, Tennessee, 37909
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Lancaster, South Carolina, 29720
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Leesburg, Florida, 34748
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Lehigh Acres, Florida, 33971
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Lenoir, North Carolina, 28645
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Lewisville, Texas, 75067
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Lincoln, California, 95648
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Lincoln, Nebraska, 68510
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Long Beach, California, 90822
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Lufkin, Texas, 75904
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Manassas, Virginia, 20110
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Marion, Ohio, 43302
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McKinney, Texas, 75069
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McKinney, Texas, 75070
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Medford, Oregon, 97504
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Merritt Island, Florida, 32952
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Metairie, Louisiana, 70006
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Miami, Florida, 33126
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Miami, Florida, 33145
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Miami, Florida, 33155
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Miami, Florida, 33165
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Miami, Florida, 33173
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Milwaukee, Wisconsin, 53226
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New Haven, Connecticut, 06716
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New York, New York, 10029
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Olathe, Kansas, 66061
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Orangeburg, South Carolina, 29118
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Orlando, Florida, 32825
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Ormond Beach, Florida, 32174
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Palo Alto, California, 94304
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Peoria, Illinois, 61602
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Plano, Texas, 75093
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Port Arthur, Texas, 77640
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Port Orange, Florida, 32127
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Portland, Oregon, 97220
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Reno, Nevada, 89506
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Renton, Washington, 98055
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Rochester, Minnesota, 55905
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Rock Hill, South Carolina, 29732
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Saint Charles, Missouri, 63301
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Salt Lake City, Utah, 94102
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San Diego, California, 92103
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San Diego, California, 92117
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San Diego, California, 92120
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Sarasota, Florida, 34239
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Scottdale, Pennsylvania, 15683
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Seneca, South Carolina, 29678
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Sheffield, Alabama, 35660
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Sherman, Texas, 75092
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Smyrna, Tennessee, 37167
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Snellville, Georgia, 30078
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Spartanburg, South Carolina, 29303
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Spring, Texas, 77379
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St Louis, Missouri, 63122
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Stockbridge, Georgia, 30281
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Sunset, Louisiana, 70584
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Syracuse, New York, 13210
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Tabor City, North Carolina, 28463
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Tampa, Florida, 33603
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Tampa, Florida, 33607
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The Bronx, New York, 10459
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Toms River, New Jersey, 08755
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Topeka, Kansas, 66604
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Upland, California, 91786
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Valparaiso, Indiana, 46383
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Waco, Texas, 76712
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Warwick, Rhode Island, 02886
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Winston-Salem, North Carolina, 27104
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Winter Park, Florida, 32789
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Wooster, Ohio, 44691
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Wyomissing, Pennsylvania, 19610
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Yorba Linda, California, 92886
Argentina21 sites
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Buenos Aires, C1414AIF
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CABA, 1426
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CABA, C1056ABJ
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CABA, C1425BEN
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CABA
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Ciudad Autónoma de Buenos Aire, C1440BRR
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Ciudad Autonomade Buenos Aires, 1426
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Ciudad de Buenos Aires, 1425
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Concepción del Uruguay, 3260
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Córdoba, X5003DCE
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Mar del Plata, 7600
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Mar del Plata, B7600FZN
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Mar del Plata, B7600GNY
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Mendoza, 5500
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Mendoza, M5500GIP
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Nueve de Julio, B6500EZL
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Ranelagh, 1886
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Rosario, S2000DEJ
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San Fernando, 1646
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San Juan Bautista, 1888
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San Miguel de Tucumán, 4000
Italy13 sites
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Bari, 70124
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Catania, 95123
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Ferrara, 44121
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Legnago, 37045
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Monza, 20900
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Naples, 80131
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Padova, 35128
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Pavia, 27100
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Riccione, 47838
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Rimini, 47921
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Roma, 00100
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Roma, 00168
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Sassari, 07100
Brazil12 sites
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Botucatu, 18618-970
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Porto Alegre, 90035074
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Porto Alegre, 90470-340
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Porto Alegre, 90610-000
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Porto Alegre, 91350-200
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Santo André, 09080-110
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São Bernardo do Campo, 09750-420
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São Paulo, 01228-200
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São Paulo, 04039-901
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Sorocaba, 18040-425
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Uberlândia, 38411-186
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Vitória, 29055-450
Russia12 sites
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Izhevsk, 426035
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Moscow, 105077
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Novosibirsk, 630008
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Novosibirsk, 630084
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Omsk, 644043
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Penza, 440067
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Perm, 614000
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Saint Petersburg, 196601
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Saint Petersburg, 197022
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StPetersburg, 191180
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Ulyanovsk, 432009
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Yekaterinburg, 620039
Spain12 sites
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Alicante, 03114
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Alzira (Valencia), 46600
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Benalmádena (Málaga), 29631
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Cáceres, 10003
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Jerez de la Frontera, 11407
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Laredo, 39770
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Loja (Granada), 18300
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Málaga, 29010
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Marbella (Málaga), 29603
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Palma de Mallorca, 07010
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Sagunto(Valencia), 46520
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Sant Boi de Llobregat, 08830
Peru11 sites
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Chancay, 15131
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Cusco
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Lima, 41
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Lima, L18
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Lima, L27
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Lima, L41
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Lima, LIMA 1
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Lima, LIMA 21
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Lima, LIMA 31
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Lima, LIMA 32
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Piura
South Africa11 sites
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Bloemfontein, 9301
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Cape Town, 1730
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Cape Town, 7570
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Cape Town, 7764
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Durban, 4001
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Johannesburg, 2001
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KwaDukuza, 4450
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Lenasia Ext8, 1820
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Mowbray, 7700
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Parow
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Pretoria, 184
Germany10 sites
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Berlin, 10119
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Berlin, 12157
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Berlin, 13187
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Berlin, 14059
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Cologne, 51069
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Cottbus, 03044
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Frankfurt, 60596
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Leipzig, 04357
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Lübeck, 23552
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Rodgau-Dudenhofen, 63110
Mexico9 sites
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Durango, 43080
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Guadalajara, 44100
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Guadalajara, 44130
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Guadalajara, 44200
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Mexico City, 6760
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Minatitlán, 96730
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Monterrey, 64460
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Sonora, 83000
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Villahermosa, 86035
Denmark8 sites
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Aalborg, 9000
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Aarhus N, 8200
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Hvidovre, 2650
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København NV, 2400
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Kolding, 6000
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Odense C, 5000
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Roskilde, 4000
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Silkeborg, 8600
Canada7 sites
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Ajax, Ontario, L1S 2J5
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Québec, Quebec, G1V 4G5
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Québec, Quebec, G2J 0C4
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Saint-Charles-Borromée, Quebec, J6E 2B4
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Trois-Rivières, Quebec, G8T 7A1
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Windsor, Ontario, N8X 1T3
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Windsor, Ontario, N8X 5A6
United Kingdom7 sites
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Bradford, BD9 6RJ
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Chertsey, KT16 0PZ
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Chester, CH2 1UL
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Doncaster, DN2 5LT
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Lancaster, LA1 4RP
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Sheffield, S5 7AU
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Wishaw, ML2 0DP
Belgium6 sites
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Brussels, 1070
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Erpent, 5101
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Gilly, 6060
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Jambes, 5100
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Liège, 4000
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Roeselare, 8800
Norway6 sites
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Arendal, 4841
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Hønefoss, N-3515
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Kråkeroy, N-1671
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Stavanger, N-4005
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Svelvik, 3060
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Trondheim, 7030
Chile5 sites
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Curicó, 3341643
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Santiago, 8380453
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Santiago, 8380456
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Talca, 3465584
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Talcahuano, 4270918
Sweden5 sites
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Lund, 221 85
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Lund, 222 21
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Malmö, 21152
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Stockholm, 114 46
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Uppsala, 75237
Austria4 sites
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Bludenz, 6700
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Feldbach, A-8330
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Hallein, 5400
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Linz, 04020
Puerto Rico2 sites
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Ponce, 00717
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San Juan, 00927
About this study
Official title: A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
Read the detailed description
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.
- Conditions
- Chronic Obstructive Pulmonary Disorder
- Being tested
- BFF MDI (PT009) 320/9.6 μg, BFF MDI (PT009) 160/9.6 μg, FF MDI (PT005) 9.6 μg
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFF MDI (PT009) 320/9.6 μgDrug
Also called Budesonide and Formoterol Fumarate Inhalation Aerosol
Blinded Treatment
BFF MDI (PT009) 160/9.6 μgDrug
Also called Budesonide and Formoterol Fumarate Inhalation Aerosol
Blinded Treatment
FF MDI (PT005) 9.6 μgDrug
Also called Formoterol Fumarate Inhalation
Blinded Treatment
| Study group | Role | What they receive |
|---|---|---|
| BFF MDI (PT009) 320/9.6 μg | Experimental | Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID Receives: Drug: BFF MDI (PT009) 320/9.6 μg |
| BFF MDI (PT009) 160/9.6 μg | Experimental | Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID Receives: Drug: BFF MDI (PT009) 160/9.6 μg |
| FF MDI (PT005) 9.6 μg | Experimental | Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID Receives: Drug: FF MDI (PT005) 9.6 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning Pre-dose Trough FEV1
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
Measured: at Week 12
Secondary outcomes (3)
Time to First Moderate or Severe COPD Exacerbation
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
Measured: over 52 weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use
Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
Measured: over 12 weeks
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.
Measured: at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start29 Apr 2016
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727660
- Sponsor's protocol ID
- PT009003
- Status last verified
- Aug 2019
- First submitted
- 30 Mar 2016
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
PubMed 35815359
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
- ClinicalTrials.gov ID
- NCT02727660
- Acronym / sponsor ID
- PT009003
- Conditions
- Chronic Obstructive Pulmonary Disorder
- Keywords
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,876 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2016 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Posted 26 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
Detailed description
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BFF MDI (PT009) 320/9.6 μg | Experimental | Drug: BFF MDI (PT009) 320/9.6 μgBudesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID |
| BFF MDI (PT009) 160/9.6 μg | Experimental | Drug: BFF MDI (PT009) 160/9.6 μgBudesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID |
| FF MDI (PT005) 9.6 μg | Experimental | Drug: FF MDI (PT005) 9.6 μgFormoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Give their signed written informed consent to participate
- At least 40 years of age and no older than 80 years of age
- COPD patients who are symptomatic
- Must be receiving one or more inhaled bronchodilators as maintenance therapy
- Must have a documented history of COPD exacerbations
Key exclusion criteria (4 listed)
- Current diagnosis of asthma
- COPD due to α1-Antitrypsin Deficiency
- Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
- Long-term-oxygen therapy (≥ 15 hours a day).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFF MDI (PT009) 320/9.6 μgAlso: Budesonide and Formoterol Fumarate Inhalation AerosolBlinded Treatment | Drug | BFF MDI (PT009) 320/9.6 μg |
| BFF MDI (PT009) 160/9.6 μgAlso: Budesonide and Formoterol Fumarate Inhalation AerosolBlinded Treatment | Drug | BFF MDI (PT009) 160/9.6 μg |
| FF MDI (PT005) 9.6 μgAlso: Formoterol Fumarate InhalationBlinded Treatment | Drug | FF MDI (PT005) 9.6 μg |
Primary outcome
Morning Pre-dose Trough FEV1
Time frame: at Week 12
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
3 secondary outcomes
Time to First Moderate or Severe COPD Exacerbation
Time frame: over 52 weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use
Time frame: over 12 weeks
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: at Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35815359Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
282 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BFF MDI (PT009) 320/9.6 μg, BFF MDI (PT009) 160/9.6 μg and FF MDI (PT005) 9.6 μg in people with Chronic Obstructive Pulmonary Disorder, run by Pearl Therapeutics, Inc. at 282 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 282 sites in United States, Argentina, Italy, Brazil, Russia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morning Pre-dose Trough FEV1 (time frame: at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.