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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01009463
Other study ID # 102871
Secondary ID
Status Completed
Phase Phase 3
First received November 5, 2009
Last updated October 9, 2017
Start date September 25, 2009
Est. completion date October 31, 2011

Study information

Verified date October 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)


Recruitment information / eligibility

Status Completed
Enrollment 1626
Est. completion date October 31, 2011
Est. primary completion date October 1, 2011
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Type of subject: outpatient

- Informed consent: Subjects must give their signed and dated written informed consent to participate.

- Gender: Male or female subjects A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<140 pmol/L) is confirmatory. OR

Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):

- Complete abstinence from intercourse from screening until the Follow-Up Phone Contact; or

- Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or

- Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or

- Injectable progestogen administered for at least 1 month prior to study medication administration and administered until the Follow-Up Phone Contact; or

- Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or

- Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or

- An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or

- Estrogenic vaginal ring; or

- Percutaneous contraceptive patches

- Age: =40 years of age at Screening (Visit 1)

- COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.

- Tobacco use: Subjects with a current or prior history of =10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history. Number of pack years = (number of cigarettes per day/20) x number of years smoked

- Severity of Disease:

- Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of =0.70 at Screening (Visit 1)

- Subjects with a measured post-albuterol/salbutamol FEV1 <70% of predicted normal values calculated (via centralized vendor equipment) using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1). Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The study provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values.

- History of Exacerbations: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable.

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.

- Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)

- a1-antitrypsin deficiency: Subjects with a1-antitrypsin deficiency as the underlying cause of COPD

- Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases

- Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1)

- Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT scan is not available within 6 months prior to Visit 1. For sites in Germany, if a chest X-ray (or CT scan) is not available in the 6 months preceding Screening (Visit 1), the subject will not be eligible for the study.

- Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's, Myasthenia Gravis, etc).

- A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).

- Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least = 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).

- Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.

- Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.

- Hypertension: Subjects with clinically significant hypertension that is uncontrolled.

- Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.

- Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.

- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years

- Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol and/or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.

- Additional medication: Unable to stop using certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)

- Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., =12 hours per day) is not exclusionary.

- Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.

- Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.

- Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.

- Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.

- Prior use of study medication/other investigational drugs: Subjects who have previously been randomized to treatment with GW642444 Inhalation Powder in the B2C111045 study, randomized to treatment in the HZC111348 study or have participated in the HZC112207, HZC102871, HZC102970, or HZC110946 studies. Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer.

- Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
FF/GW642444 Inhalation Powder
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) delivered within one dry powder inhaler (DPI) device for COPD
GW642444 Inhalation Powder
Long Acting Beta Agonist(LABA) Inhalation Powder via DPI

Locations

Country Name City State
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Cipolletti Río Negro
Argentina GSK Investigational Site Ciudad Autónoma de Buenos Aires
Argentina GSK Investigational Site Ciudad Autónoma de Buenos Aires
Argentina GSK Investigational Site Mendoza
Australia GSK Investigational Site Cairns Queensland
Australia GSK Investigational Site Daw Park South Australia
Australia GSK Investigational Site Frankston Victoria
Australia GSK Investigational Site Garran Australian Capital Territory
Australia GSK Investigational Site Geelong Victoria
Australia GSK Investigational Site Heidelberg Victoria
Australia GSK Investigational Site Kippa Ring Queensland
Australia GSK Investigational Site Nedlands Western Australia
Canada GSK Investigational Site Burlington Ontario
Canada GSK Investigational Site Corunna Ontario
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Quebec
Canada GSK Investigational Site St. John's Newfoundland and Labrador
Canada GSK Investigational Site Sudbury Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Vancouver British Columbia
Chile GSK Investigational Site Santiago
Chile GSK Investigational Site Temuco Región De La Araucania
Chile GSK Investigational Site Valparaiso Valparaíso
Estonia GSK Investigational Site Rakvere
Estonia GSK Investigational Site Tallinn
Estonia GSK Investigational Site Tallinn
Estonia GSK Investigational Site Tartu
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Geesthacht Schleswig-Holstein
Italy GSK Investigational Site Cassano Murge (BA) Puglia
Italy GSK Investigational Site Eboli (SA) Campania
Italy GSK Investigational Site Ferrara Emilia-Romagna
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Roma Lazio
Italy GSK Investigational Site Roma Lazio
Italy GSK Investigational Site Telese Terme (BN) Campania
Italy GSK Investigational Site Torrette (AN) Marche
Italy GSK Investigational Site Tradate (VA) Lombardia
Mexico GSK Investigational Site Guadalajara Jalisco
Mexico GSK Investigational Site Monterrey Nuevo León
Mexico GSK Investigational Site Tijuana Baja California Norte
Mexico GSK Investigational Site Zapopan Jalisco
Netherlands GSK Investigational Site Bunnik
Netherlands GSK Investigational Site Enschede
Netherlands GSK Investigational Site Etten-leur
Netherlands GSK Investigational Site Harderwijk
Netherlands GSK Investigational Site Heerlen
Netherlands GSK Investigational Site Helmond
Netherlands GSK Investigational Site Nijverdal
Netherlands GSK Investigational Site Rotterdam
Netherlands GSK Investigational Site Sneek
Netherlands GSK Investigational Site Spijkenisse
Netherlands GSK Investigational Site Veldhoven
Netherlands GSK Investigational Site Voerendaal
Peru GSK Investigational Site Jesus Maria Lima
Peru GSK Investigational Site Lima
Peru GSK Investigational Site Lima
Peru GSK Investigational Site San Martin de Porres Lima
Philippines GSK Investigational Site Dagupan City
Philippines GSK Investigational Site Quezon City
Philippines GSK Investigational Site Quezon City
Philippines GSK Investigational Site Quezon City
South Africa GSK Investigational Site Boksburg North
South Africa GSK Investigational Site Cape Town
South Africa GSK Investigational Site Cape Town Gauteng
South Africa GSK Investigational Site Durban
South Africa GSK Investigational Site Durban
South Africa GSK Investigational Site Groenkloof
South Africa GSK Investigational Site Lynnwood Manor
South Africa GSK Investigational Site Lyttleton
South Africa GSK Investigational Site Mueckelneck Gauteng
South Africa GSK Investigational Site Paarl
South Africa GSK Investigational Site Panorama
South Africa GSK Investigational Site Reiger Park
South Africa GSK Investigational Site Somerset West
South Africa GSK Investigational Site Witbank
Sweden GSK Investigational Site Göteborg
Sweden GSK Investigational Site Göteborg
Sweden GSK Investigational Site Höllviken
Sweden GSK Investigational Site KIL
Sweden GSK Investigational Site Örebro
United Kingdom GSK Investigational Site Doncaster
United Kingdom GSK Investigational Site High Heaton, Newcastle upon Tyne Tyne & Wear
United Kingdom GSK Investigational Site Liverpool
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site London
United States GSK Investigational Site Abingdon Virginia
United States GSK Investigational Site Anderson South Carolina
United States GSK Investigational Site Austell Georgia
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Avon Indiana
United States GSK Investigational Site Bay Pines Florida
United States GSK Investigational Site Belleville Illinois
United States GSK Investigational Site Billings Montana
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Boerne Texas
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Charlottesville Virginia
United States GSK Investigational Site Chattanooga Tennessee
United States GSK Investigational Site Chester South Carolina
United States GSK Investigational Site Chula Vista California
United States GSK Investigational Site Clearwater Florida
United States GSK Investigational Site Clearwater Florida
United States GSK Investigational Site Columbia Maryland
United States GSK Investigational Site Dayton Ohio
United States GSK Investigational Site Decatur Georgia
United States GSK Investigational Site Elizabeth City North Carolina
United States GSK Investigational Site Fort Myers Florida
United States GSK Investigational Site Fort Worth Texas
United States GSK Investigational Site Fredericksburg Virginia
United States GSK Investigational Site Gaffney South Carolina
United States GSK Investigational Site Gainesville Florida
United States GSK Investigational Site Greenwood South Carolina
United States GSK Investigational Site Greer South Carolina
United States GSK Investigational Site Iowa City Iowa
United States GSK Investigational Site Jasper Alabama
United States GSK Investigational Site Johnston Rhode Island
United States GSK Investigational Site Kingwood Texas
United States GSK Investigational Site Lafayette Indiana
United States GSK Investigational Site Lake Jackson Texas
United States GSK Investigational Site Lakewood Washington
United States GSK Investigational Site Lawrenceville Georgia
United States GSK Investigational Site Lebanon New Hampshire
United States GSK Investigational Site Lenexa Kansas
United States GSK Investigational Site Lincoln California
United States GSK Investigational Site Long Beach California
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Medford Oregon
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Minneapolis Minnesota
United States GSK Investigational Site Minneapolis Minnesota
United States GSK Investigational Site Mission Viejo California
United States GSK Investigational Site Muncie Indiana
United States GSK Investigational Site Munfordville Kentucky
United States GSK Investigational Site New Orleans Louisiana
United States GSK Investigational Site New Tazewell Tennessee
United States GSK Investigational Site New York New York
United States GSK Investigational Site New York New York
United States GSK Investigational Site Newburgh Indiana
United States GSK Investigational Site Ocean City New Jersey
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Ormond Beach Florida
United States GSK Investigational Site Owensboro Kentucky
United States GSK Investigational Site Palo Alto California
United States GSK Investigational Site Peoria Arizona
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Plymouth Minnesota
United States GSK Investigational Site Poway California
United States GSK Investigational Site Rancho Mirage California
United States GSK Investigational Site Richmond Virginia
United States GSK Investigational Site River Forest Illinois
United States GSK Investigational Site Riverside California
United States GSK Investigational Site Rolling Hills Estates California
United States GSK Investigational Site Saint Charles Missouri
United States GSK Investigational Site Saint Joseph Michigan
United States GSK Investigational Site Salisbury North Carolina
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Santa Monica California
United States GSK Investigational Site Scottsdale Arizona
United States GSK Investigational Site Sellersville Pennsylvania
United States GSK Investigational Site Seneca South Carolina
United States GSK Investigational Site Sepulveda California
United States GSK Investigational Site South Burlington Vermont
United States GSK Investigational Site Southfield Michigan
United States GSK Investigational Site Spokane Washington
United States GSK Investigational Site Stamford Connecticut
United States GSK Investigational Site Sunset Louisiana
United States GSK Investigational Site Tacoma Washington
United States GSK Investigational Site Tamarac Florida
United States GSK Investigational Site Temple Texas
United States GSK Investigational Site Torrance California
United States GSK Investigational Site Tulsa Oklahoma
United States GSK Investigational Site Virginia Beach Virginia
United States GSK Investigational Site Wenatchee Washington
United States GSK Investigational Site Wichita Kansas
United States GSK Investigational Site Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  Estonia,  Germany,  Italy,  Mexico,  Netherlands,  Peru,  Philippines,  South Africa,  Sweden,  United Kingdom, 

References & Publications (1)

Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Sanford L, Lettis S, Crim C, Calverley PM. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2013 May;1(3):210-23. doi: 10.1016/S2213-2600(13)70040-7. Epub 2013 Apr 12. Erratum in: Lancet Respir Med. 2013 May;1(3):186. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization. From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal
Secondary Time to First Occurrence of Moderate or Severe COPD Exacerbation Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented. From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Secondary Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization. From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Secondary Change From Baseline in Trough FEV1 at Week 52 (Visit 11) Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions. Baseline to Visit 11 (Week 52)/Early Withdrawal
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