Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma

Browse trials for

• Asthma 3,921

Keywords

• wheezing, short of breath, laba, inhaler

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 91 is close to the median of 83 across 2,752 interventional studies indexed under Asthma.

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Study arms

• Experimental
  Treatment Period Sequence 1

  Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening

  Drug: Indacaterol 27.5 mcg · Drug: Placebo

• Experimental
  Treatment Period Sequence 2

  Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening

  Drug: Indacaterol 37.5 · Drug: Placebo

• Experimental
  Treatment Period Sequence 3

  Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening

  Drug: Indacaterol 55 mcg · Drug: Placebo

• Experimental
  Treatment Sequence Period 4

  Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening

  Drug: Indacaterol 75 mcg · Drug: Placebo

• Experimental
  Treatment Period Sequence 5

  Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening

  Drug: Indacaterol 150 mcg · Drug: Placebo

• Experimental
  Treatment Period Sequence 6

  Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening

  Drug: Placebo

Interventions

• DrugIndacaterol 27.5 mcg

  indacaterol 27.5 mcg twice daily inhaled once via inhaler

• DrugIndacaterol 37.5

  Indacaterol 37.5 mcg once daily, inhaled once via inhaler

• DrugIndacaterol 55 mcg

  Indacaterol 55 mcg once daily, inhaled once via inhaler

• DrugIndacaterol 75 mcg

  Indacaterol 75 mcg once daily, inhaled once via inhaler

• DrugIndacaterol 150 mcg

  Indacaterol 150 mcg once daily, inhaled once via inhaler

• DrugPlacebo

  Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Primary outcomes

1. Change From Period Baseline in FEV1 (L) AUC(0-24h)

   Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.

   Time frame: Day 1 (24 hours)

Secondary outcomes

1. Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)

   Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 12 hours post-dose period.

   Time frame: Day 1 (12 hours)

2. Change From Period Baseline in Peak FEV1 (L)

   Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points.

   Time frame: Day 1 (24 hours)

3. Change From Period Baseline in Trough FEV1 (L)

   Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements at different time points.

   Time frame: Day 1 (24 hours)

4. Change From Period Baseline in FVC (L) AUC (0-24h)

   Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

   Time frame: Day 1 (24 hours)

Baseline characteristics