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NCT Number: NCT02541006

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 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).

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiotropium 18 mcg

Drug

tiotropium 18 mcg once a day

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Neutec Ar-Ge San ve Tic A.Ş

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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