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Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02541006
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

Brief Summary:
The objective of this study is to compare the bronchodilator efficacy a of tiotropium inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Condition or disease Intervention/treatment Phase
COPD Drug: Tiotropium 18 mcg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-group, Phase IV Study to Compare the Bronchodilator Efficacy of Tiotropium (18 µg Once Daily [od]) Delivered Via a DISCAIR With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
Study Start Date : November 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tiotropium 18 mcg dry powder for inhalation
Tiotropium 18 mcg dry powder for inhalation, one inhalation, once daily with the DISCAIR
Drug: Tiotropium 18 mcg
tiotropium 18 mcg once a day

Active Comparator: SPIRIVA 18 mcg HANDIHALER
Tiotropium 18 mcg dry powder capsul for inhalation one capsule once daily with the HandiHaler
Drug: Tiotropium 18 mcg
tiotropium 18 mcg once a day




Primary Outcome Measures :
  1. Median maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) [ Time Frame: prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose ]
  2. Percantage (%) change from baseline in FEV1 and FVC [ Time Frame: prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose ]
  3. Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours -Post-dose [ Time Frame: Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose ]
  4. - Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response [ Time Frame: Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose ]

Secondary Outcome Measures :
  1. Time to onset of bronchodilator effect and maximum effect [ Time Frame: 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose ]
  2. Adverse Events [ Time Frame: predose and up to 24 hours postdose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 40 years and older with moderate to severe COPD diagnosis
  • Current/former smokers with at least a 10 pack-year history of cigarette smoking
  • Patients with established clinical COPD and severity defined as a post-broncodilator FEV1/FVC ratio of ≤0.70 and FEV1 ≤80 % of predicted normal at screening
  • Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
  • Have no excacerbation within last 4 weeks
  • Hava capability of communicate with investigator
  • Accept to adapt the procedures of study protocol
  • Signed and dated informed consent

Exclusion Criteria:

  • History of hypersensitivity to anticholinergics
  • Diagnosis of asthma
  • History of alergic rinit and athopy
  • Current or history of lung cancer
  • Known symptomatic prostatic hypertrophy requiring drug therapy
  • Known narrow-angle glaucoma requiring drug therapy
  • Have experienced exacerbation of COPD or lower respiratory inflammatory disease requiring use of antibiotics, oral or parenteral corticosteroids (CS) within 4 weeks prior to screening visit and/or during run-in period
  • Patients vaccinated with poored virüs vaccinate within 2 weeks prior to screening visit and/or during run-in period
  • Patients with a recent history of myocardial infarction, acute ischemic cardiac disease or severe cardiac arrhythmia requiring drug therapy
  • Women who are pregnant or lactating or are planning on becoming pregnant during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541006


Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş
Investigators
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Study Director: Neutec Ar-Ge San ve Tic A.S Neutec Ar-Ge San ve Tic A.S Clinical Trial
Publications:
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Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT02541006    
Other Study ID Numbers: Neu-21.12
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: November 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neutec Ar-Ge San ve Tic A.Ş:
FEV1
FVC
AUC 0-24
bronchodilator efficacy
tiotropium
Additional relevant MeSH terms:
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Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action